Obesity Clinical Trial
— CROWNOfficial title:
The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
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 |
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.
Status | Completed |
Enrollment | 236 |
Est. completion date | June 24, 2018 |
Est. primary completion date | June 24, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Nulliparous women aged 18 or above - BMI = 30 at the time of labor induction - Singleton gestation - Cephalic presentation (includes successful external cephalic version) - Intact fetal membranes - Unfavorable cervix (Bishop score of = 6) - Gestational age = 32 weeks Exclusion Criteria - Patient not candidate for IOL with misoprostol as deemed by the treating physician - Multiple gestation - Major fetal anomalies - Fetal demise |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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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