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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

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ClinicalTrials.gov Identifier: NCT00703014
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : November 24, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Conditions Pregnancy
Neonates
Interventions Drug: Corifollitropin Alfa 150 μg
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
Drug: Placebo for Corifollitropin Alfa
Drug: Placebo for RecFSH/Follitropin beta
Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
Drug: Ganirelix
Biological: hCG
Biological: Progesterone
Enrollment 541
Recruitment Details  
Pre-assignment Details Period one consists of mothers from the Base Trial P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of mothers (N = 541) who enrolled in trial P05712. Period three consists of miscarried/stillborn fetuses and infants born in trial P05712.
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses/Infants recFSH 200 IU
Hide Arm/Group Description Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800) Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Period Title: Mothers Base Trial P05787 (NCT00696800)
Started 757 [1] 752 [1] 0 0
Treated 756 [2] 750 [3] 0 0
Embryo Transfer 672 [4] 704 [4] 0 0
Completed 295 [5] 286 [5] 0 0
Not Completed 462 466 0 0
[1]
Randomized in Base Trial P05787 (NCT00696800)
[2]
Intent-To-Treat (ITT) group in Base Trial P05787 (NCT00696800)
[3]
ITT group in Base Trial P05787 (NCT006968000)
[4]
Embryo transfer (ET) in Base Trial P05787 (NCT006968000)
[5]
ITT group in P05712, ongoing pregnancy at 10 weeks after ET in Base Trial P05787 (NCT006968000)
Period Title: Mothers Follow Up Trial P05712
Started 274 [1] 267 [1] 0 0
Completed 241 [2] 235 [2] 0 0
Not Completed 33 32 0 0
Reason Not Completed
Did not complete follow up in P05712             33             32             0             0
[1]
Eligible participants who completed Base Trial P05787 and then enrolled in Follow Up Trial P05712
[2]
Completed Follow Up in Trial P05712
Period Title: Fetuses/Infants Follow Up Trial P05712
Started 0 0 352 [1] 326 [1]
Live Born Infants 0 0 344 [2] 315 [2]
Completed 0 0 305 [3] 284 [3]
Not Completed 0 0 47 42
Reason Not Completed
Did not complete follow up in P05712             0             0             47             42
[1]
Fetuses in Follow Up Trial P05712
[2]
Live born infants in Follow Up Trail P05712
[3]
Infants in P05712 with Follow Up Completed
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Total
Hide Arm/Group Description Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Total of all reporting groups
Overall Number of Baseline Participants 274 267 541
Hide Baseline Analysis Population Description
Eligible mothers from the Base Trial P05787 (NCT00696800) who enrolled in Follow Up Trial P05712
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 267 participants 541 participants
31.4  (3.2) 31.3  (3.5) 31.3  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 267 participants 541 participants
Female
274
 100.0%
267
 100.0%
541
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time Frame Up to one day following delivery (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU
Hide Arm/Group Description:
Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Overall Number of Participants Analyzed 274 267
Measure Type: Number
Unit of Measure: Participants
222 214
2.Primary Outcome
Title Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
Hide Description A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame Up to one day following delivery (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU
Hide Arm/Group Description:
Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Overall Number of Participants Analyzed 274 267
Measure Type: Number
Unit of Measure: Participants
129 117
3.Primary Outcome
Title Number of Infants Born in Current Follow Up Trial Experiencing AEs
Hide Description An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time Frame Up to 12 weeks following delivery (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.
Arm/Group Title Infants Corifollitropin Alfa 150 µg Infants recFSH 200 IU
Hide Arm/Group Description:
Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Overall Number of Participants Analyzed 344 315
Measure Type: Number
Unit of Measure: Participants
164 161
4.Primary Outcome
Title Number of Infants in Current Follow Up Trial Experiencing SAEs
Hide Description A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame Up to 12 weeks following delivery (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.
Arm/Group Title Infants Corifollitropin Alfa 150 µg Infants recFSH 200 IU
Hide Arm/Group Description:
Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Overall Number of Participants Analyzed 344 315
Measure Type: Number
Unit of Measure: Participants
106 94
5.Primary Outcome
Title Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
Hide Description The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Time Frame At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU
Hide Arm/Group Description:
Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Overall Number of Participants Analyzed 756 750
Measure Type: Number
Unit of Measure: Percentage of Participants
35.6 34.4
6.Primary Outcome
Title Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
Hide Description The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Time Frame At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU
Hide Arm/Group Description:
Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Overall Number of Participants Analyzed 672 704
Measure Type: Number
Unit of Measure: Percentage of Participants
40.0 36.6
Time Frame Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth
Adverse Event Reporting Description All study treatments were considered to be administered to the mother.
 
Arm/Group Title Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses/Infants recFSH 200 IU
Hide Arm/Group Description Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800) Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
All-Cause Mortality
Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses/Infants recFSH 200 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses/Infants recFSH 200 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   129/274 (47.08%)      117/267 (43.82%)      106/352 (30.11%)      94/326 (28.83%)    
Blood and lymphatic system disorders         
Anaemia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 6/352 (1.70%)  6 3/326 (0.92%)  3
Haemorrhagic anaemia  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Placental transfusion syndrome  1  0/274 (0.00%)  0 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Splenomegaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Thrombocytopenia  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Thrombocytopenia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Cardiac disorders         
Bradycardia foetal  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Bradycardia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Cardiac arrest  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Cardiac hypertrophy  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Cardio-respiratory arrest neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Myocardial ischaemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Nodal rhythm  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Pulmonary valve stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Tachycardia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Tachycardia foetal  1  1/274 (0.36%)  1 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Congenital, familial and genetic disorders         
Abnormal palmar/planta creases  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Accessory auricle  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Ankyloglossia congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Atrial septal defect  1  0/274 (0.00%)  0 0/267 (0.00%)  0 5/352 (1.42%)  5 11/326 (3.37%)  11
Atrioventricular septal defect  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Bat ear  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Cervical rib  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Chondrodystrophy  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Cleft lip  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Cleft palate  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Cleft uvula  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Clinodactyly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital anaemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital aortic anomaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital aortic stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital aortic valve stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital central nervous system anomaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 3/352 (0.85%)  3 0/326 (0.00%)  0
Congenital cerebral cyst  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital choroid plexus cyst  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Congenital coronary artery malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital cyst  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital eyelid malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Congenital foot malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital hand malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital hearing disorder  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital hip deformity  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Congenital hydrocephalus  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Congenital inguinal hernia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital labia pudendi adhesions  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital mitral valve stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital naevus  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Congenital nose malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital optic nerve anomaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital ovarian anomaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital pyelocaliectasis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Congenital spinal cord anomaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Congenital torticollis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Congenital tracheomalacia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Craniotabes  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Cryptorchism  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 2/326 (0.61%)  2
Dacryostenosis congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 3/352 (0.85%)  3 4/326 (1.23%)  4
Duodenal atresia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Exomphalos  1  0/274 (0.00%)  0 0/267 (0.00%)  0 7/352 (1.99%)  7 3/326 (0.92%)  3
Eyelid ptosis congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Fallot's tetralogy  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Gastrointestinal malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Haemangioma congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 4/352 (1.14%)  4 3/326 (0.92%)  3
Heart disease congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Hip dysplasia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 4/352 (1.14%)  4 1/326 (0.31%)  1
Hypertelorism of orbit  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Hypospadias  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Immunodeficiency congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Patent ductus arteriosus  1  0/274 (0.00%)  0 0/267 (0.00%)  0 5/352 (1.42%)  5 6/326 (1.84%)  6
Phimosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Pilonidal cyst congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 3/352 (0.85%)  3 2/326 (0.61%)  2
Plagiocephaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Pulmonary artery stenosis congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Pulmonary valve stenosis congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Pyloric stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Rhesus haemolytic disease of newborn  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Single umbilical artery  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Skull malformation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Strabismus congenital  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Supernumerary nipple  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Syndactyly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 0/326 (0.00%)  0
Talipes  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 2/326 (0.61%)  2
Tracheo-oesophageal fistula  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Trisomy 21  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Ventricular septal defect  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 6/326 (1.84%)  6
Ear and labyrinth disorders         
Hearing impaired  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Hypoacusis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Endocrine disorders         
Secondary hypogonadism  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Eye disorders         
Dacryostenosis acquired  1  0/274 (0.00%)  0 0/267 (0.00%)  0 5/352 (1.42%)  5 2/326 (0.61%)  2
Eye disorder  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Lacrimal cyst  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Retinopathy of prematurity  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 1/326 (0.31%)  1
Gastrointestinal disorders         
Anal stenosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Diarrhoea  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Dysphagia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Gastrooesophageal reflux disease  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Inguinal hernia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Intestinal perforation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Necrotising enterocolitis neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Short-bowel syndrome  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
General disorders         
Death  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Drug withdrawal syndrome neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Fever neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Inflammation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Neonatal multi-organ faillure  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Sudden infant death syndrome  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Hepatobiliary disorders         
Hyperbilirubinaemia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 9/352 (2.56%)  9 8/326 (2.45%)  8
Jaundice cholestatic  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Neonatal cholestasis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Immune system disorders         
Anaphylactic shock  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Infections and infestations         
Appendicitis  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Bacterial sepsis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Genital herpes  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Klebsiella sepsis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Incision site infection  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Infection  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Lobar pneumonia  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Meningitis streptococcal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Neonatal infection  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Neonatal pneumonia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Oral candidiasis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Respiratory syncytial virus bronchiolitis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Respiratory syncytial virus infection  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Sepsis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Sepsis neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 7/352 (1.99%)  7 5/326 (1.53%)  5
Upper respiratory tract infection  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Urinary tract infection  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Viral infection  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Injury, poisoning and procedural complications         
Fall  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Joint dislocation  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Post procedural haemorrhage  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Rib fracture  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Investigations         
Acoustic stimulation tests abnormal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Amniotic fluid volume decreased  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Blood glucose decreased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Blood glucose fluctuation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Blood sodium increased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Body temperature decreased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
C-reactive protein increased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 0/326 (0.00%)  0
Cardiac murmur  1  0/274 (0.00%)  0 0/267 (0.00%)  0 6/352 (1.70%)  6 3/326 (0.92%)  3
Cytomegalovirus antibody positive  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Foetal heart rate abnormal  1  3/274 (1.09%)  3 2/267 (0.75%)  2 2/352 (0.57%)  2 0/326 (0.00%)  0
Foetal heart rate decreased  1  1/274 (0.36%)  1 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Haemoglobin Barts present  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Heart rate decreased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Hepatic enzyme increased  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Metabolism and nutrition disorders         
Cow's milk intolerance  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Dehydration  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Fatty acid deficiency  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Gestational diabetes  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Hyperglycaemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Hypermagnesaemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Hypocalcaemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Hypoglycaemia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 3/352 (0.85%)  3 3/326 (0.92%)  3
Loctose intolerance  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Metabolic acidosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Neonatal hyponatraemia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 3/326 (0.92%)  3
Musculoskeletal and connective tissue disorders         
Back pain  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Head deformity  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Hypotonia neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Joint range of motion decreased  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 0/326 (0.00%)  0
Osteopenia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Positional plagiocephaly  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Posture abnormal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Haemangioma of skin  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Lymphangioma  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Nervous system disorders         
Brain oedema  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Cerebral haemorrhage neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Cerebral infarction  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Cerebral ventricle dilatation  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Convulsion neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 0/326 (0.00%)  0
Dizziness  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Encephalopathy neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Intraventricular haemorrhage neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Neurological symptom  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Superior sagittal sinus thrombosis  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  2/274 (0.73%)  2 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Antepartum haemorrhage  1  2/274 (0.73%)  2 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Arrested labour  1  12/274 (4.38%)  12 15/267 (5.62%)  15 0/352 (0.00%)  0 0/326 (0.00%)  0
Breech presentation  1  26/274 (9.49%)  26 23/267 (8.61%)  23 0/352 (0.00%)  0 0/326 (0.00%)  0
Caput succedaneum  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Cephalo-pelvic disproportion  1  5/274 (1.82%)  5 3/267 (1.12%)  3 0/352 (0.00%)  0 0/326 (0.00%)  0
Cervical incompetence  1  4/274 (1.46%)  4 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Chorioamnionitis  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Discordant twin  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 2/326 (0.61%)  2
Face presentation  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Failed induction of labour  1  4/274 (1.46%)  4 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Foetal distress syndrome  1  6/274 (2.19%)  6 13/267 (4.87%)  13 1/352 (0.28%)  1 2/326 (0.61%)  2
Foetal growth retardation  1  4/274 (1.46%)  4 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Foetal hypokinesia  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Foetal macrosomia  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Foetal malposition  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Foetal malpresentation  1  4/274 (1.46%)  4 4/267 (1.50%)  4 0/352 (0.00%)  0 0/326 (0.00%)  0
HELLP syndrome  1  2/274 (0.73%)  2 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Hydrops foetalis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Hyperemesis gravidarum  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Imminent abortion  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Intrapartum haemorrhage  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Jaundice neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 8/352 (2.27%)  8 8/326 (2.45%)  8
Meconium in amniotic fluid  1  0/274 (0.00%)  0 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Meconium stain  1  0/274 (0.00%)  0 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Multiple pregnancy  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Oligohydramnios  1  1/274 (0.36%)  1 3/267 (1.12%)  3 0/352 (0.00%)  0 0/326 (0.00%)  0
Placenta accreta  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Placenta praevia  1  5/274 (1.82%)  5 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Polyhydramnios  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Postpartum haemorrhage  1  2/274 (0.73%)  2 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Pre-eclampsia  1  12/274 (4.38%)  12 10/267 (3.75%)  10 0/352 (0.00%)  0 0/326 (0.00%)  0
Pregnancy induced hypertension  1  4/274 (1.46%)  4 3/267 (1.12%)  3 0/352 (0.00%)  0 0/326 (0.00%)  0
Premature baby  1  0/274 (0.00%)  0 0/267 (0.00%)  0 56/352 (15.91%)  56 48/326 (14.72%)  48
Premature labour  1  37/274 (13.50%)  37 33/267 (12.36%)  33 0/352 (0.00%)  0 0/326 (0.00%)  0
Premature rupture of membranes  1  8/274 (2.92%)  8 6/267 (2.25%)  6 0/352 (0.00%)  0 0/326 (0.00%)  0
Premature separation of placenta  1  6/274 (2.19%)  6 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Previous caesarean section  1  3/274 (1.09%)  3 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Prolonged labour  1  2/274 (0.73%)  2 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Small for dates baby  1  0/274 (0.00%)  0 0/267 (0.00%)  0 3/352 (0.85%)  3 6/326 (1.84%)  6
Stillbirth  1  1/274 (0.36%)  1 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Threatened labour  1  10/274 (3.65%)  10 11/267 (4.12%)  11 0/352 (0.00%)  0 0/326 (0.00%)  0
Transverse presentation  1  3/274 (1.09%)  3 3/267 (1.12%)  3 0/352 (0.00%)  0 0/326 (0.00%)  0
Twin pregnancy  1  16/274 (5.84%)  16 15/267 (5.62%)  15 0/352 (0.00%)  0 0/326 (0.00%)  0
Umbilical cord abnormality  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Umbilical cord around neck  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Umbilical cord prolapse  1  1/274 (0.36%)  1 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Uterine contractions during pregnancy  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Uterine hypotonus  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Psychiatric disorders         
Agitation neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Post-traumatic stress disorder  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Renal colic  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Renal failure neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Renal tubular necrosis  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Reproductive system and breast disorders         
Cervix oedema  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Chordee  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Haemorrhagic ovarian cyst  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Ovarian enlargement  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Ovarian hyperstimulation syndrome  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Ovarian torsion  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Pelvic pain  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Shortened cervix  1  0/274 (0.00%)  0 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Uterine atony  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Vaginal haemorrhage  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Apnoea  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Apparent life threatening event  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Atelectasis neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Bronchopulmonary dysplasia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Infantile apnoeic attack  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 3/326 (0.92%)  3
Neonatal hypoxia  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Neonatal respiratory distress syndrome  1  0/274 (0.00%)  0 0/267 (0.00%)  0 13/352 (3.69%)  13 12/326 (3.68%)  12
Neonatal respiratory failure  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 4/326 (1.23%)  4
Neonatal tachypnoea  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Pneumomediastinum  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Pneumothorax  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 2/326 (0.61%)  2
Pulmonary oedema  1  0/274 (0.00%)  0 2/267 (0.75%)  2 0/352 (0.00%)  0 0/326 (0.00%)  0
Respiratory disorder neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Sleep apnoea syndrome  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Transient tachypnoea of the newborn  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 4/326 (1.23%)  4
Skin and subcutaneous tissue disorders         
Hair growth abnormal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 0/326 (0.00%)  0
Pruritus  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Surgical and medical procedures         
Abortion induced  1  1/274 (0.36%)  1 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Appendicectomy  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Caesarean section  1  0/274 (0.00%)  0 5/267 (1.87%)  5 0/352 (0.00%)  0 0/326 (0.00%)  0
Evacuation of retained products of conception  1  1/274 (0.36%)  1 0/267 (0.00%)  0 0/352 (0.00%)  0 0/326 (0.00%)  0
Labour induction  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Selective abortion  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  0/274 (0.00%)  0 1/267 (0.37%)  1 0/352 (0.00%)  0 0/326 (0.00%)  0
Hypertension neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 2/352 (0.57%)  2 0/326 (0.00%)  0
Hypoperfusion  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Lymphocele  1  0/274 (0.00%)  0 0/267 (0.00%)  0 0/352 (0.00%)  0 1/326 (0.31%)  1
Neonatal hypotension  1  0/274 (0.00%)  0 0/267 (0.00%)  0 1/352 (0.28%)  1 1/326 (0.31%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mothers Corifollitropin Alfa 150 µg Mothers recFSH 200 IU Fetuses/Infants Corifollitropin Alfa 150 µg Fetuses/Infants recFSH 200 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/274 (40.88%)      118/267 (44.19%)      37/352 (10.51%)      41/326 (12.58%)    
Blood and lymphatic system disorders         
Anaemia  1  20/274 (7.30%)  20 17/267 (6.37%)  17 0/352 (0.00%)  0 0/326 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  15/274 (5.47%)  16 22/267 (8.24%)  23 2/352 (0.57%)  2 8/326 (2.45%)  8
Dyspepsia  1  27/274 (9.85%)  31 22/267 (8.24%)  23 0/352 (0.00%)  0 0/326 (0.00%)  0
Gastrooesophageal reflux disease  1  6/274 (2.19%)  6 3/267 (1.12%)  3 16/352 (4.55%)  16 17/326 (5.21%)  17
Vomiting  1  20/274 (7.30%)  22 14/267 (5.24%)  15 0/352 (0.00%)  0 3/326 (0.92%)  3
Nausea  1  34/274 (12.41%)  38 27/267 (10.11%)  29 0/352 (0.00%)  0 2/326 (0.61%)  2
General disorders         
Fatigue  1  17/274 (6.20%)  19 15/267 (5.62%)  17 0/352 (0.00%)  0 0/326 (0.00%)  0
Oedema Peripheral  1  21/274 (7.66%)  26 13/267 (4.87%)  16 0/352 (0.00%)  0 0/326 (0.00%)  0
Metabolism and nutrition disorders         
Gestational diabetes  1  10/274 (3.65%)  10 14/267 (5.24%)  14 0/352 (0.00%)  0 0/326 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  25/274 (9.12%)  28 20/267 (7.49%)  25 0/352 (0.00%)  0 0/326 (0.00%)  0
Nervous system disorders         
Headache  1  24/274 (8.76%)  31 31/267 (11.61%)  37 0/352 (0.00%)  0 0/326 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Antepartum haemorrhage  1  19/274 (6.93%)  21 14/267 (5.24%)  19 0/352 (0.00%)  0 0/326 (0.00%)  0
Jaundice neonatal  1  0/274 (0.00%)  0 0/267 (0.00%)  0 22/352 (6.25%)  22 20/326 (6.13%)  20
Threatened labour  1  18/274 (6.57%)  18 15/267 (5.62%)  15 0/352 (0.00%)  0 0/326 (0.00%)  0
Reproductive system and breast disorders         
Pelvic pain  1  14/274 (5.11%)  18 10/267 (3.75%)  16 0/352 (0.00%)  0 0/326 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any scientific paper, presentation, or other communication concerning the clinical trial will first be presented to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent. The Sponsor shall have the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00703014     History of Changes
Other Study ID Numbers: P05712
2004-004772-36 ( EudraCT Number )
38821 ( Other Identifier: Organon )
MK-8962-005 ( Other Identifier: Merck )
First Submitted: June 18, 2008
First Posted: June 20, 2008
Results First Submitted: November 18, 2014
Results First Posted: November 24, 2014
Last Update Posted: April 17, 2017