Trial Outcomes & Findings for Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital (NCT NCT03098966)
NCT ID: NCT03098966
Last Updated: 2018-01-26
Results Overview
Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).
Recruitment status
COMPLETED
Target enrollment
368 participants
Primary outcome timeframe
24 hours after onset of trial of labor
Results posted on
2018-01-26
Participant Flow
This is a retrospective study that was performed at Ain Shams University Maternity Hospital during the 3-year period from January 2013 to December 2015.
Participant milestones
| Measure |
Trial Of Labour After Caesarean Section
The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:
-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy
-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
|
|---|---|
|
Overall Study
STARTED
|
368
|
|
Overall Study
COMPLETED
|
368
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
Baseline characteristics by cohort
| Measure |
Trial Of Labour After Caesarean Section
n=368 Participants
The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:
-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy
-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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
368 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 4.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
368 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Egypt
|
368 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 hours after onset of trial of laborMode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).
Outcome measures
| Measure |
Trial Of Labour After Caesarean Section
n=368 Participants
The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:
-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy
-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
|
|---|---|
|
Number of Participants With Successful Vaginal Birth
|
317 Participants
|
SECONDARY outcome
Timeframe: 48 hours after onset of trial of labor• Maternal morbidity: * Uterine rupture * Surgical injuries (during emergency CS) * Hemorrhage and blood transfusion * Peripartum hysterectomy
Outcome measures
| Measure |
Trial Of Labour After Caesarean Section
n=368 Participants
The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:
-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy
-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
|
|---|---|
|
Number of Participants Who Had Maternal Morbidity
|
338 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Trial Of Labour After Caesarean Section
n=368 Participants
The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:
-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy
-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
|
|---|---|
|
Adverse Perinatal Outcomes
|
332 Participants
|
Adverse Events
Trial Of Labour After Caesarean Section
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place