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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02223949
• Date of registration: 21/08/2014
• Prospective Registration: Yes
• Primary sponsor: Hillel Yaffe Medical Center
• Public title: Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods
• Scientific 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.
• Date of first enrolment: October 2014
• Target sample size: 624
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02223949
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Israel

Contacts

• Name: Asnat Walfisch, MD
• Affiliation: Hillel Yaffe Medical Center

• Name: Saja Murra Anobosy, MD

• Name: Saja Murra Anabosy, MD

• Name: Saja Murra Anabosy, MD
• Affiliation: Hillel Yaffe Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Labor Complications

Obesity

Intervention(s)

Device: Cook double balloon catheter

Drug: PGE1 tablet

Primary Outcome(s)

Cesarian section rate [Time Frame: 24 hours]

Secondary Outcome(s)

Incidence of excessive uterine activity Incidence of excessive uterine activity [Time Frame: 24 hours]

Intra-partum or postpartum fever [Time Frame: 48 hours]

morbidity and mortality [Time Frame: 48 hours]

Incidence of meconium staining [Time Frame: 24 hours]

Mode of delivery [Time Frame: 24 hours]

Need for oxytocin induction and/or augmentation of labor [Time Frame: 24 hours]

The ripening-to-delivery time interval [Time Frame: 24 hours]

Active labor onset [Time Frame: 24 hours]

Proportion of vaginal delivery [Time Frame: 24 hours]

The number of neonates who were admitted to the neonatal intensive care unit [Time Frame: 48 hours]

The proportion of neonates with 5-minute Apgar scores of less than 7 [Time Frame: 48 hours]

Treatment failure [Time Frame: 12-24 hours]

Secondary ID(s)

0033-14-HYMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors