Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

Phase 2

• Conditions: Obesity; Labor Complications
• Interventions: Drug: PGE1 tablet; Device: Cook double balloon catheter

• Registration Number: NCT02223949
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 624

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGE1 tablet insertion	PGE1 tablet	Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.
Cook double balloon catheter	Cook double balloon catheter	Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.

Primary Outcome Measures

Name	Time	Method
Cesarian section rate	24 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of excessive uterine activity Incidence of excessive uterine activity	24 hours	At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.
Active labor onset	24 hours
The ripening-to-delivery time interval	24 hours
Proportion of vaginal delivery	24 hours
Mode of delivery	24 hours	NVD vs. instrumental
Intra-partum or postpartum fever	48 hours
Incidence of meconium staining	24 hours
Treatment failure	12-24 hours	Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening
Need for oxytocin induction and/or augmentation of labor	24 hours
The proportion of neonates with 5-minute Apgar scores of less than 7	48 hours
The number of neonates who were admitted to the neonatal intensive care unit	48 hours
morbidity and mortality	48 hours	Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel