Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

NCT02150954 | Completed Phase 4 Results

• 1 other identifier: Pro00001312
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

Conditions

Induction of Labor

Keywords

induction of labor; pitocin; foley bulb

Outcome Measures

Primary Outcomes (2)

• Time to the Second Stage of Labor

  The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.

  foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)

• Time to Delivery

  Time from foley balloon placement until neonate delivery

  foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)

Secondary Outcomes (7)

• Rate of Cesarean Delivery

  during admission for delivery, up to approximately 4 days

• Time to Active Labor

  during admission for delivery, up to approximately 4 days

• Time to Foley Expulsion or Removal

  foley bulb placement until removal, up to 10 hours

• Incidence of Uterine Hyperstimulation

  during admission for delivery, up to approximately 4 days

• Neonatal Outcome: Birthweight

  at time of birth (0 to 1 hour)

Study Arms (2)

foley bulb induction with low dose pitocin

ACTIVE COMPARATOR

Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.

Drug: pitocin

foley bulb with standard incremental pitocin infusion protocol

ACTIVE COMPARATOR

Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Drug: pitocin

Interventions

pitocin DRUG

Also known as: oxytocin

foley bulb induction with low dose pitocin; foley bulb with standard incremental pitocin infusion protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a singleton pregnancy
• Term pregnancy (\> 37 weeks gestation)
• Age ≥ 18 years
• Bishop score \< 5
• Contractions \< 6/hr
• Reassuring fetal heart tracing

You may not qualify if:

• Rupture of membranes
• Antepartum bleeding
• Fetal death
• Placenta previa or low lying placenta
• Active genital herpes infection
• Previous use of an induction or preinduction agent during the current pregnancy
• EFW \>4500 grams
• Non reassuring fetal testing
• Inability to pass foley through cervix
• Prior cesarean section

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chad Grotegut , MD
• Organization: Duke University Medical Center

chad.grotegut@dm.duke.edu

Study Officials

• Chad Grotegut, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Brennan Fitzpatrick, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 30, 2014
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 26, 2023
• Results First Posted: July 23, 2014

Record last verified: 2014-06