- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325256
Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor
August 24, 2022 updated by: Ahmed Mohamed Abbas, Assiut University
Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study
Induction of labour (IOL) nowadays is a common procedure in obstetric practice.
Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries.
The success of IOL mainly depends upon "favourability" of the cervix which is usually assessed by manual examination and Scored as Bishop Score.
However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Assiut, Cairo, Egypt, 002
- Ahmed Abbas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women who will attend the labor unit for induction
Description
Inclusion Criteria:
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Fetus with longitudinal lie and vertex presentation.
- Intact membranes.
- No vaginal bleeding.
Exclusion Criteria:
- Patients with previous cesarean delivery.
- Previous uterine surgery.
- Antepartum hemorrhage.
- Cephalopelvic disproportion.
- Category II or III non-stress test.
- Malpresentation.
- Intrauterine fetal death.
- Fetal growth restriction.
- Fetuses with major congenital malformations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
study group
All pregnant women who will attend the labor unit for induction of labour due to different indications during the study period will be invited to participate in the study.
|
length of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured.
Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted.
maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of successful induction of labor
Time Frame: 24 hours
|
an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥4 cm within 12 h of initiating oxytocin on the first day of induction
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 25, 2022
Last Update Submitted That Met QC Criteria
August 24, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IOLSC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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