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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098966
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 368 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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.
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
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Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT03098966    
Other Study ID Numbers: TOLAC
First Posted: April 4, 2017    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: January 26, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No