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Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor

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ClinicalTrials.gov Identifier: NCT02694315
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Cervical Dystocia
Interventions Other: Bishop score
Other: cervical length
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction of Labor
Hide Arm/Group Description

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination

cervical length: measuring cervical length by trans-vaginal ultrasound

Period Title: Overall Study
Started 200
Completed 200
Not Completed 0
Arm/Group Title Induction of Labor
Hide Arm/Group Description

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination

cervical length: measuring cervical length by trans-vaginal ultrasound

Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
Raslan et al., 2013 reported accuracy of cervical length or Bishop score was 72% vs 63%. So, proportion of discordant pairs is 0.37. A sample of 200 would achieve a power of 80% to detect statistical significance for an effect size equivalent to odds ratio of 1.9. Two sided McNemar test was used with a confidence level 95%.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 200 participants
23.5
(21 to 27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
200
 100.0%
Male
0
   0.0%
Gestational age  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 200 participants
39.8
(38.2 to 40.4)
Previous abortions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
no abortions 173
one abortion 22
two abortions 4
three abortions 1
Indication of induction of labor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
severe pre-eclampsia 8
mild pre-eclampsia 11
intrauterine growth restriction 3
oligohydramnios 17
postdate 89
term rupture of membranes 72
Need for oxytocin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
needed oxytocin 116
did not need oxytocin 84
Outcome of induction of labor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
successful vaginal delivery 114
need for cesarean section 86
1.Primary Outcome
Title Cervical Length Prior to Labor Induction
Hide Description median cervical length measured by transvaginal ultrasound in centimetres
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Induction of Labor
Hide Arm/Group Description:

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination

cervical length: measuring cervical length by trans-vaginal ultrasound

Overall Number of Participants Analyzed 200
Median (Inter-Quartile Range)
Unit of Measure: centimetres
successful induction of labor
2.9
(2.8 to 3.1)
failed induction of labor
3
(2.8 to 3.2)
2.Primary Outcome
Title Bishop Score Prior to Induction of Labor
Hide Description

median Bishop score assessed by digital vaginal examination as follows:

  1. Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.
  2. Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.
  3. Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.
  4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.
  5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.

Note that a score more than 10 means patient is in labor not needing induction of labor.

Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Induction of Labor
Hide Arm/Group Description:

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination

cervical length: measuring cervical length by trans-vaginal ultrasound

Overall Number of Participants Analyzed 200
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
successful induction of labor
4
(3 to 5)
failed induction of labor
3
(3 to 4)
Time Frame All participants and their livebirths were followed for 72 hours following delivery for adverse events
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction of Labor
Hide Arm/Group Description

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination

cervical length: measuring cervical length by trans-vaginal ultrasound

All-Cause Mortality
Induction of Labor
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Induction of Labor
Affected / at Risk (%) # Events
Total   0/200 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Induction of Labor
Affected / at Risk (%) # Events
Total   19/200 (9.50%)    
Pregnancy, puerperium and perinatal conditions   
low APGAR score  [1]  10/200 (5.00%)  10
low birth weight  [2]  1/200 (0.50%)  1
neonatal ICU admission  [3]  5/200 (2.50%)  5
maternal traumatic birth injury  [4]  3/200 (1.50%)  3
Indicates events were collected by systematic assessment
[1]
neonatal APGAR score less than 7
[2]
fetal birth weight less than 2500 grams
[3]
number of neonates admitted in neonatal ICU
[4]
any trauma in the birth tract related to delivery
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
Name/Title: amr ahmed mahmoud riad
Organization: Ain Shams Maternity hospital
Phone: 01005347179 ext +2
Responsible Party: Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02694315     History of Changes
Other Study ID Numbers: sonographic cervical length
First Submitted: February 23, 2016
First Posted: February 29, 2016
Results First Submitted: March 11, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016