Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
1 other identifier
observational
368
0 countries
N/A
Brief Summary
The purpose of the study to evaluate the practice and short term maternal and perinatal outcomes of trial of labor after cesarean section offered to women at Ain Shams University Maternity Hospital (ASUMH) during the 3-year period from January 2013 to December 2015.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedResults Posted
Study results publicly available
January 26, 2018
CompletedJanuary 26, 2018
June 1, 2017
2.8 years
March 28, 2017
April 4, 2017
June 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Successful Vaginal Birth
Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).
24 hours after onset of trial of labor
Secondary Outcomes (2)
Number of Participants Who Had Maternal Morbidity
48 hours after onset of trial of labor
Adverse Perinatal Outcomes
48 hours postpartum
Eligibility Criteria
This is a retrospective study that was performed at Ain Shams University Maternity Hospital Records of hospital admissions during the planned time frame were reviewed. Subjects eligible for conduction of a Trial Of Labor After Cesarean section (TOLAC), were included, while those ineligible for TOLAC were excluded from the study dataset.
You may qualify if:
- Women admitted in labour
- One prior caesarean section
- Singleton pregnancy
- Vertex-presenting fetus
You may not qualify if:
- Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy or myomectomy
- Short inter-delivery interval (\<12 months)
- Complications in the previous CS (e.g. puerperal sepsis)
- Obstetric indication for CS (either elective or emergency):
- Placenta praevia
- Placental abruption
- Documented evidence of cephalopelvic disproportion
- Fetal macrosomia (estimated fetal weight \>4 kg)
- Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus
- Fetal distress or non-reassuring Cardiotocography pattern
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Results Point of Contact
- Title
- Dr.Rehab Mohamed Abdelrahman
- Organization
- Ain Shams University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 4, 2017
Study Start
January 1, 2013
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
January 26, 2018
Results First Posted
January 26, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share