Vaginal Birth After CesareanNCT03098966
Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
An observational study of Vaginal Birth After Cesarean, run by Ain Shams University.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Vaginal Birth After Cesarean
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Adult
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.
Who may be able to join
- Women admitted in labour
- One prior caesarean section
- Singleton pregnancy
- Vertex-presenting fetus
Who cannot join
- 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
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- 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
About this study
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.
Read the 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
- Conditions
- Vaginal Birth After Cesarean
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours after onset of trial of labor
Secondary outcomes (2)
Number of Participants Who Had Maternal Morbidity
- Maternal morbidity:
- Uterine rupture
- Surgical injuries (during emergency CS)
- Hemorrhage and blood transfusion
- Peripartum hysterectomy
Measured: 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
Measured: 48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startJan 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal Birth After CesareanStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098966
- Sponsor's protocol ID
- TOLAC
- Status last verified
- Jun 2017
- First submitted
- 28 Mar 2017
- Last updated
- 26 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
- ClinicalTrials.gov ID
- NCT03098966
- Acronym / sponsor ID
- TOLAC
- Conditions
- Vaginal Birth After Cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 26 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Women admitted in labour
- One prior caesarean section
- Singleton pregnancy
- Vertex-presenting fetus
Key exclusion criteria (10 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Number of Participants Who Had Maternal Morbidity
Time frame: 48 hours after onset of trial of labor
Adverse Perinatal Outcomes
Time frame: 48 hours postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Birth After Cesarean, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Vaginal Birth (time frame: 24 hours after onset of trial of labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.