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

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hillel Yaffe Medical Center
• Treatments: Alprostadil

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.