Clinical trial NCT02223949: Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods
Official title: Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obesity
Labor Complications
Keywords: Obesity
Labor complications
Induction of labor
Mechanical cervical ripening
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-22
Enrollment: 624
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.


Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older.
* Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
* Having a Bishop score of 4 points or less.
* Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
* Willingness to comply with the protocol for the duration of the study.
* Has agreed and signed an informed consent after given oral and written explanation.

Exclusion Criteria:

* Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
* Ruptured membranes.
* Previous cesarian section or presence of any uterine scar.
* Documented labor with four or more spontanous uterine contractions per hour.
* Suspected fetal distress necessitating immediate intervention.
* Proven malignancy of the cervix.
* Active vaginal bleeding.
* Active inflammatory or purulent condition of the lower genital tract.
* Active asthma.

Primary outcomes:
measure: Cesarian section rate
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of excessive uterine activity Incidence of excessive uterine activity
timeFrame: 24 hours
measure: Active labor onset
timeFrame: 24 hours
measure: Proportion of vaginal delivery
timeFrame: 24 hours
measure: Treatment failure
timeFrame: 12-24 hours
measure: The ripening-to-delivery time interval
timeFrame: 24 hours
measure: Need for oxytocin induction and/or augmentation of labor
timeFrame: 24 hours
measure: Mode of delivery
timeFrame: 24 hours
measure: Intra-partum or postpartum fever
timeFrame: 48 hours
measure: Incidence of meconium staining
timeFrame: 24 hours
measure: The proportion of neonates with 5-minute Apgar scores of less than 7
timeFrame: 48 hours
measure: The number of neonates who were admitted to the neonatal intensive care unit
timeFrame: 48 hours
measure: morbidity and mortality
timeFrame: 48 hours
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Saja Murra Anabosy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillel Yaffe Medical Center
name: Asnat Walfisch, MD
role: STUDY_CHAIR
References: