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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Labor Complications
• Intervention / Treatment: Device: Cook double balloon catheter; Drug: PGE1 tablet

• Study Type: Interventional
• Enrollment (Anticipated): 624
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 169
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Cook double balloon catheter
Active Comparator: PGE1 tablet insertion; 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.	Drug: PGE1 tablet; Other Names: Prostaglandin E1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cesarian section rate	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of excessive uterine activity Incidence of excessive uterine activity	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.	24 hours
Active labor onset		24 hours
Proportion of vaginal delivery		24 hours
Treatment failure	Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening	12-24 hours
The ripening-to-delivery time interval		24 hours
Need for oxytocin induction and/or augmentation of labor		24 hours
Mode of delivery	NVD vs. instrumental	24 hours
Intra-partum or postpartum fever		48 hours
Incidence of meconium staining		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	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).	48 hours

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Saja Murra Anabosy, MD, Hillel Yaffe Medical Center; Study Chair: Asnat Walfisch, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Induction of labor; Labor complications; Mechanical cervical ripening
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: 0033-14-HYMC