Clinical trial NCT03098966: Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
Official title: Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Birth After Cesarean
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 368
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Vaginal Birth
timeFrame: 24 hours after onset of trial of labor
Secondary outcomes:
measure: Number of Participants Who Had Maternal Morbidity
timeFrame: 48 hours after onset of trial of labor
measure: Adverse Perinatal Outcomes
timeFrame: 48 hours postpartum
Other outcomes:
Locations:
Study officials:
References: