- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06680804
Factors Affecting Success of Vaginal Birth After Cesarean Section
November 7, 2024 updated by: Nahla Rashwan Ezz-eldine, Sohag University
Factors Affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- Clinical data will be collected from the participants including demographic details such as age, maternal age, parity, BMI, gestational age based on last menstrual period or early ultrasound scans available.
- Full medical and surgical history, previous CS details as an indication, and previous complications.
- Patients' clinical abdominal and per vaginal examination on admission (cervical dilatation, effacement head station, and position).
- CTG attached on admission (to exclude fetal distress).
- Laboratory investigations that will be done before delivery and postpartum, Labor progress on the partogram will be assessed as regard duration of both first and second stages of labor if any instrumental delivery will be done.
- Radiology investigations such as US.
- Records for patients' vital signs, fetal cardiac activity during labor, vaginal bleeding, delivery notes, fetal weight, and 5 minutes APGAR score, and any recorded maternal or fetal complications.
- If failed VBAC: Causes of failure maternal and fetal outcomes will be recorded and immediate CS to be done
Study Type
Observational
Enrollment (Estimated)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nahla Rashwan ezzeldine, master
- Phone Number: 01013774970
- Email: nashwa_rashwan_post@med.sohag.edu.eg
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
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
All patients admitted for vaginal delivery with previous lower segment cesarean section .
Age from 20 to 40 years.Time interval more than 1.5 years from previous caesarean section.
Description
Inclusion Criteria:
• Age from 20 to 40 years.
- Time interval more than 1.5 years from previous caesarean section.
- Single viable full-term pregnancy in vertex presentation.
- Reactive cardiotocography (CTG) on admission.
- Spontaneous labor onset.
- Clinically adequate pelvis.
- Single fetus
- Average AFI fetus
Exclusion Criteria:
• Women with previous upper segment cesarean section or hysterotomy scar.
- Any obstetric complications such as fetal malpresentation, placenta previa, or medical disorders like diabetes mellitus or preeclampsia.
- Presence of any signs and symptoms of scar dehiscence or ruptured uterus, known uterine fibroid or anomaly.
- Suspected fetal macrosomia (weight more than 4 kg).
- Multifetal pregnancy.
- Parturient women who refused the trial of vaginal birth after caesarean section.
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 |
|---|---|
|
Group I: Successful VBAC group
Successful VBAC group whose take chance for vaginal delivery.
|
chance for vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
|
|
Group II: Failed VBAC group
Failed VBAC group whose take chance for vaginal delivery.
|
chance for vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
successful vaginal delivery
Time Frame: From November 2024 to April 2025
|
successful vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
|
From November 2024 to April 2025
|
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 (Estimated)
December 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
November 7, 2024
First Submitted That Met QC Criteria
November 7, 2024
First Posted (Estimated)
November 8, 2024
Study Record Updates
Last Update Posted (Estimated)
November 8, 2024
Last Update Submitted That Met QC Criteria
November 7, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- soh-Ned-15-10_9MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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