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Completed

NCT Number: NCT03098966

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Successful Vaginal Birth

    Time frame: 24 hours after onset of trial of labor

    Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).

Secondary outcomes

  1. Number of Participants Who Had Maternal Morbidity

    Time frame: 48 hours after onset of trial of labor

    • Maternal morbidity:
    • Uterine rupture
    • Surgical injuries (during emergency CS)
    • Hemorrhage and blood transfusion
    • Peripartum hysterectomy
  2. Adverse Perinatal Outcomes

    Time frame: 48 hours postpartum

    • 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2017
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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