Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Birth After Cesarean

Detailed Description

This is a retrospective study that was performed at Ain Shams University Maternity Hospital.

The following data will be gathered (whenever available), tabulated and subjected to the proper statistical analysis:

History:

• Age
• Duration of marriage
• Inter-pregnancy interval
• Gestational age (by menstrual dates or US)
• Obstetric history (parity, mode of delivery, assisted vaginal delivery, previous vaginal birth after cesarean section, neonatal outcome)
• Present and past history of any medical, surgical or obstetric problems; history of infection after previous CS

General examination:

• General condition
• Vital data

Abdominal examination:

• Fundal level
• Estimated fetal weight (clinically or by US)
• Scar tenderness

Vaginal examination on admission:

• Cervical status
• Station of presenting part
• Membranes status
• Pelvic adequacy

Investigations performed:

• Complete Blood Count
• Ultrasonography

Intrapartum management:

• Progress and duration of labor according to partogram (or admission-delivery time)
• Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any

Mode of delivery:

• Vaginal delivery (spontaneous, assisted, complications)
• Cesarean section (indication, scar dehiscence)

Postpartum Data:

• Postpartum hemorrhage
• Blood transfusion
• Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality

• Study Type: Observational
• Enrollment (Actual): 368

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Women admitted in labour
• One prior caesarean section
• Singleton pregnancy
• Vertex-presenting fetus

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Had Maternal Morbidity	• Maternal morbidity: Uterine rupture; Surgical injuries (during emergency CS); Hemorrhage and blood transfusion; Peripartum hysterectomy	48 hours after onset of trial of labor
Adverse Perinatal Outcomes	• Adverse perinatal outcomes: Apgar score; Neonatal Intensive Care Unit admission; Respiratory morbidity, e.g. transient tachypnoea of the newborn; Hypoxic ischaemic encephalopathy; Birth trauma; Mortality	48 hours postpartum

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TOLAC

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