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

NCT02223949 | Unknown Phase 2 DMC

• 1 other identifier: 0033-14-HYMC
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Labor Complications

Keywords

Obesity; Labor complications; Induction of labor; Mechanical cervical ripening

Outcome Measures

Primary Outcomes (1)

• Cesarian section rate

  24 hours

Secondary Outcomes (12)

• Incidence of excessive uterine activity Incidence of excessive uterine activity

  24 hours

• Active labor onset

  24 hours

• Proportion of vaginal delivery

  24 hours

• Treatment failure

  12-24 hours

• The ripening-to-delivery time interval

  24 hours

Study Arms (2)

Cook double balloon catheter

EXPERIMENTAL

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

PGE1 tablet insertion

ACTIVE COMPARATOR

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

Interventions

Cook double balloon catheter DEVICE

Cook double balloon catheter

PGE1 tablet DRUG

Also known as: Prostaglandin E1

PGE1 tablet insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 169, Israel

Location

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Conditions

Obesity; Obstetric Labor Complications

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Saja Murra Anabosy, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

• Asnat Walfisch, MD

  Hillel Yaffe Medical Center

  STUDY CHAIR

Central Study Contacts

Saja Murra Anabosy, MD

CONTACT

+972 50 9260067; saja83@gmail.com

Asnat Walfisch, MD

CONTACT

+972 50 4492200; asnatwalfisch@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

IL (1)