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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02639429
Other study ID # HSC-MS-15-0895
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2016
Est. completion date June 24, 2018

Study information

Verified date August 2019
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vaginal Misoprostol

Device:
Foley Balloon + Vaginal Misoprostol


Locations

Country Name City State
United States The University of Texas Health Science Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With a Need for Cesarean Delivery Induction to delivery
Secondary Indication for Cesarean Delivery Categories of Indications for Cesarean Delivery:
= Cephalopelvic disproportion
= Failed induction/Failure to progress
= Cord prolapse
= Non-reassuring fetal tracing
= Malpresentation
= Placental abruption
= Other
Induction to delivery
Secondary Induction-to-delivery Interval in Hours Induction to delivery
Secondary Number of Participants With a Need for Oxytocin Augmentation Induction to delivery
Secondary Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated = 5 contractions in a 10 minute period averaged over a 30-minute window. Induction to delivery
Secondary Number of Participants With Clinical Chorioamnionitis Clinical chorioamnionitis is indicated by maternal fever = 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid. Induction to delivery
Secondary Number of Participants With a Need for Operative Vaginal Delivery Induction to delivery
Secondary Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity Measures of maternal morbidity assessed:
Maternal ICU admission
Postpartum endometritis
Surgical-site infections prior to discharge
Venous thromboembolism
Need for transfusion
Maternal death
Induction to discharge (approximately 5 days)
Secondary Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Number of Newborns With Transient Tachypnea (TTN) From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Number of Newborns With Respiratory Distress Syndrome (RDS) From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Number of Newborns With Meconium Aspiration Syndrome From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Number of Newborns With Culture-proven Sepsis From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Number of Newborns With Seizures From delivery to neonatal discharge (approximately 2 to 7 days)
Secondary Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity Measures of neonatal morbidity assessed:
Apgar score = 7 at 5 mins
Umbilical cord potential of hydrogen (pH) < 7.1
Neonatal injury: brachial plexus injury, fracture
Perinatal death
From delivery to neonatal discharge (approximately 2 to 7 days)
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