Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml

Induction of Labor Clinical Trial

Official title:

Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451308
• Other study ID #: H4114729401-01
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2007
• Last updated: July 31, 2013
• Start date: November 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.

Description:

All potential candidates will be approached for the study and undergo written consent if willing to participate. Each candidate will be randomized to 30ml or 60 ml Foley balloon catheter volume. A random number generator will be used and within a sealed envelope will be placed the assignment. Nulliparous and multiparous patients will be randomized separately. The patient will be positioned for a standard cervical exam - either for digital or speculum exam, depending on the individual patient preference and provider choice. For digital exam, a sterile Foley balloon catheter will be digitally placed in the endocervical canal, into the extraamniotic space (between the fetal head, external to the unruptured amniotic sac, above the internal os of the cervix). For speculum exam, the cervix is wiped three times with a Betadine cleansing solution, and a sterile Foley balloon catheter bulb will be placed under direct visualization into the endocervical canal, into the extraamniotic space. Once the balloon is in place the provider inserts 30ml of sterile saline. The provider then leaves the room. The patient's nurse opens the envelope and if the patient is allocated to the 60ml volume group, the nurse adds an additional 30ml of sterile saline. If the patient is in the 30ml group, the RN staff will simulate placement of additional saline into the foley balloon without actually placing any additional saline in order to also blind the patients to their assigned group. The MD/CNM providers will then return to the room, blinded to the inflation of the Foley balloon, and the balloon catheter will be placed under tension by taping the external end to the patient's inner thigh. Oxytocin will be started within 30 minutes of the Foley balloon catheter placement, using the standard intravenous oxytocin protocol. Additional manual traction on the Foley balloon catheter will be performed every 30 minutes until Foley balloon catheter expulsion. A sterile cervical exam will be performed after spontaneous Foley catheter expulsion to evaluate post-balloon cervical dilation. No further procedures or tests specific to this study will be required beyond this point; only data collection on the above study outcomes during the remaining course of the patient's labor will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Reproductive aged women, pregnant, term gestation (>37 weeks), undergoing induction of labor, cervical exam acceptable as a candidate for Foley balloon catheter placement (Bishop score <5), cephalic fetal presentation.

Exclusion Criteria:

• Regular contractions on admission, rupture of membranes, previous uterine scar, low-lying placenta (measured <3cm to internal os), Bishop score > 5, contraindication to attempt at vaginal birth, non-English/Spanish speaking, unable to give consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Procedure:
• Induction of labor with foley balloon - 60cc of saline
60 cc of fluid
• Induction of labor with foley balloon with 30cc
30cc of saline in foley

Locations

Country	Name	City	State
United States	University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of vaginal delivery within 24 hours		within 24 hours	No
Secondary	Cervical dilation after Foley balloon catheter expulsion		within 24hours	No
Secondary	Time to catheter expulsion		hours	No
Secondary	Duration of the first stage of labor		hours	No
Secondary	Time interval from induction to active labor		hours	No
Secondary	Induction to delivery interval		hours	No
Secondary	Presence of abnormal vaginal bleeding		hours	Yes
Secondary	Peak oxytocin requirement during induction and labor augmentation		hours	No
Secondary	Epidural utilization, diagnosis of chorioamnionitis		hours	No
Secondary	Meconium stained amniotic fluid, placental abruption		hours	Yes
Secondary	Cesarean delivery rate, operative vaginal delivery rate		hours	No
Secondary	Indication for operative vaginal or cesarean delivery		hours	No
Secondary	Rate of cervical laceration		hours	Yes
Secondary	Birthweight		hours	No
Secondary	5 minute Apgar score		hours	Yes
Secondary	Umbilical cord arterial blood pH analysis		hours	Yes