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

Vaginal Birth After Cesarean Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098966
• Other study ID #: TOLAC
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: June 16, 2017
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Birth After Cesarean

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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