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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00706264
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Hospital Universitario de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Preterm Birth
Intervention Device: Silicon ring (Arabin Pessary)
Enrollment 385
Recruitment Details You are right that our fi rst planned sample size was 2780 patients. However, after the first interim analysis, and in accordance with the advice of our Data Monitoring Committee, the protocol was amended to reach the new and fi nal sample size.
Pre-assignment Details  
Arm/Group Title Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Hide Arm/Group Description Expectant management: Current conventional management.

Placement of arabin pessary since 23 weeks until 37 weeks

Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.

Period Title: Overall Study
Started 193 192
Completed 190 190
Not Completed 3 2
Arm/Group Title Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks Total
Hide Arm/Group Description Both groups were seen by the clinical team of the trial at each centre every month until delivery. Transabdominal ultrasonography was done for fetal biometries and wellbeing, clinical questionnaire was administered for confi rmation of correct device placement in the pessary group (fi gure 2), vaginal swab was taken for study of bacteriological infection, and transvaginal ultra sonography was done to measure cervical length (fi gure 3) The pessary was removed during the 37th week of gestation. Indications for pessary removal before this time were active vaginal bleeding, risk of preterm labour with persistent contractions despite tocolysis, or severe patient discomfort. Total of all reporting groups
Overall Number of Baseline Participants 190 190 380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 190 participants 380 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
190
 100.0%
190
 100.0%
380
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 190 participants 380 participants
29.6  (5.4) 30.3  (5.1) 30.1  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 190 participants 380 participants
Female
190
 100.0%
190
 100.0%
380
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 190 participants 380 participants
Hispanic or Latino
56
  29.5%
58
  30.5%
114
  30.0%
Not Hispanic or Latino
134
  70.5%
132
  69.5%
266
  70.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 190 participants 190 participants 380 participants
190 190 380
1.Primary Outcome
Title Spontaneous Delivery Before 34 Completed Weeks
Hide Description Number of spontaneous preterm births before 34 weeks occurred in each group.
Time Frame Between 24 and 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
51
  26.8%
12
   6.3%
2.Secondary Outcome
Title Birthweight Less Than 1500 g
Hide Description Number of newborns whose birthweight is less than 1500 grams
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
26
  13.7%
9
   4.7%
3.Secondary Outcome
Title Birthweight Less Than 2500 g
Hide Description Number of newborns whose birthweight is less than 2500 grams
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Hide Arm/Group Description:
Expectant management: usual management
Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
56
  29.5%
17
   8.9%
4.Secondary Outcome
Title Intrauterine Fetal Demise
Hide Description The number of fetal deaths in the pessary group was compared to those in the no pessary group
Time Frame Pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Neonatal Death
Hide Description The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.5%
0
   0.0%
6.Secondary Outcome
Title Intraventricular Haemorrhage
Hide Description The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
0
   0.0%
7.Secondary Outcome
Title Respiratory Distress Syndrome
Hide Description The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
23
  12.1%
5
   2.6%
8.Secondary Outcome
Title Retinopathy of Prematurity
Hide Description The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
0
   0.0%
9.Secondary Outcome
Title Necrotising Enterocolitis
Hide Description The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
0
   0.0%
10.Secondary Outcome
Title Treatment for Sepsis
Hide Description The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
12
   6.3%
3
   1.6%
11.Secondary Outcome
Title Composite Adverse Outcomes
Hide Description The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
30
  15.8%
5
   2.6%
12.Secondary Outcome
Title Spontaneous Delivery Before 28 Completed Weeks
Hide Description Number of preterm births before 28 weeks occurred in each group.
Time Frame Between 24 and 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
16
   8.4%
4
   2.1%
13.Secondary Outcome
Title Any Delivery Before 34 Completed Weeks
Hide Description Number of all preterm births before 34 weeks occurred in each group.
Time Frame Between 24 and 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
53
  27.9%
14
   7.4%
14.Secondary Outcome
Title Spontaneous Delivery Before 37 Completed Weeks
Hide Description Number of preterm births before 37 weeks occurred in each group.
Time Frame Between 24 and 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
113
  59.5%
41
  21.6%
15.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Number of weeks of gestation completed by time of delivery
Time Frame At time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Mean (Standard Deviation)
Unit of Measure: weeks
34.9  (4.0) 37.7  (2.0)
16.Secondary Outcome
Title Use of Tocolysis
Hide Description Number of participants required use of tocolytic medication
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
101
  53.2%
64
  33.7%
17.Secondary Outcome
Title Use of Antenatal Steroids
Hide Description Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
121
  63.7%
80
  42.1%
18.Secondary Outcome
Title Chorioamnionitis
Hide Description Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
6
   3.2%
5
   2.6%
19.Secondary Outcome
Title Vaginal Bleeding
Hide Description Number of participants who experienced bleeding from lower genital tract during antepartum period
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
9
   4.7%
7
   3.7%
20.Secondary Outcome
Title Preterm Premature Rupture of Membranes
Hide Description Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
17
   8.9%
3
   1.6%
21.Secondary Outcome
Title Cesarean Delivery
Hide Description Number of participants that underwent cesarean delivery
Time Frame At time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
40
  21.1%
41
  21.6%
22.Secondary Outcome
Title Vaginal Discharge
Hide Description Number of participants who experienced an increased vaginal discharge.
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 190 190
Measure Type: Count of Participants
Unit of Measure: Participants
87
  45.8%
190
 100.0%
23.Secondary Outcome
Title Pessary Repositioning Without Removal
Hide Description Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 0 190
Measure Type: Count of Participants
Unit of Measure: Participants
0
27
  14.2%
24.Secondary Outcome
Title Pessary Withdrawal
Hide Description Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame participants will be followed for the duration of pregnancy, up to nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Intervention: No Pessary Experimental: Pessary
Hide Arm/Group Description:
No pessary will be used. Subjects will receive standard obstetrical care and management.
Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Overall Number of Participants Analyzed 0 190
Measure Type: Count of Participants
Unit of Measure: Participants
0
1
   0.5%
Time Frame Starting at 24 weeks until 28 days after birth
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Hide Arm/Group Description Expectant management: usual management Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
All-Cause Mortality
Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%) 
Hide Serious Adverse Events
Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Expectant Management Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/190 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria M Goya
Organization: Hospital Vall d'Hebron
Phone: 934893085 ext 4652
EMail: maria.goya@vhir.org
Layout table for additonal information
Responsible Party: Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT00706264    
Other Study ID Numbers: PECEP-TRIAL
First Submitted: June 24, 2008
First Posted: June 27, 2008
Results First Submitted: February 11, 2018
Results First Posted: March 17, 2021
Last Update Posted: March 17, 2021