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

Hillel Yaffe Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Labor Complications; Obesity

Treatments: Device: Cook double balloon catheter; Drug: PGE1 tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02223949

0033-14-HYMC

Details and patient eligibility

About

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.

Enrollment: 624 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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624 participants in 2 patient groups

Cook double balloon catheter

Experimental group

Description:

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.

Treatment:

Device: Cook double balloon catheter

PGE1 tablet insertion

Active Comparator group

Description:

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.

Treatment:

Drug: PGE1 tablet