Outpatient Labor Induction With the Transcervical Foley Balloon

NCT ID: NCT02210598

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

Brief Summary

This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.

Detailed Description

This is a randomized controlled trial.

Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induction of labor, or at a later clinic date. If they agree to participate, patients will be randomized and enrolled in the study at that time. Those who consent will be randomized into Group A (Experimental Group) and Group B (Control Group). No stratification criteria will be used.

Patients randomized to the control group will undergo induction of labor using the standard foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position, an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Patients randomized to the experimental group will undergo outpatient induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per protocol.

In accordance with the Friedman curve and current LAC+USC practice, primigravid participants will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and multigravid participants will be given 14 hours before a failed induction is diagnosed. Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any obstetric indication as decided by the on-duty house staff. Finally, at patient request, intravenous or regional anesthesia will be made available at any time during the labor and delivery process.

Conditions

Pregnancy; Labor; Forced or Induced, Affecting Fetus or Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inpatient Foley balloon induction

Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Group Type: ACTIVE_COMPARATOR

inpatient Foley balloon induction

Intervention Type: DEVICE

The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Oxytocin

Intervention Type: DRUG

When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.

Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.

outpatient Foley balloon induction

Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.

Group Type: EXPERIMENTAL

outpatient Foley balloon induction

Intervention Type: DEVICE

The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.

Oxytocin

Intervention Type: DRUG

When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.

Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.

Interventions

inpatient Foley balloon induction

The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Intervention Type: DEVICE

outpatient Foley balloon induction

The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.

Intervention Type: DEVICE

Oxytocin

When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.

Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.

Intervention Type: DRUG

Other Intervention Names

18-French Bard catheter; 18-French Bard catheter

Eligibility Criteria

Inclusion Criteria

• Viable Intrauterine Pregnancy
• Greater than or equal to 37 weeks gestation on date of induction
• Cephalic Presentation
• Medically indicated induction of labor
• AFI greater than or equal to 5
• Patient able to be contacted by phone and demonstrates an understanding of the return instructions
• Cervical Dilation 2cm or less

Exclusion Criteria

• Placenta Previa/Low Lying Placenta
• Placenta accreta/increta/percreta
• Undiagnosed vaginal bleeding
• Preeclampsia or HELLP Syndrome
• Intrauterine Growth Restriction
• Rupture of Membranes
• Prior cesarean section or transfundal uterine surgery
• Twin Gestation
• Fetal Anomaly
• Rh Isoimmunization
• Fetal Demise
• Uterine Tachysystole
• Less than 18 years of age
• HIV Infection
• Active herpes, hepatitis B or C infection
• Latex Allergy
• EFW>4000g
• Chorioamnionitis
• Non-English or Non-Spanish Speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Patrick M Mullin, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick M Mullin, MD

Role: STUDY_DIRECTOR

University of Southern California

Yen Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Richard Lee, MD

Role: STUDY_DIRECTOR

University of Southern California

Locations

Los Angeles County + University of Southern California Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick M Mullin, MD

Role: CONTACT

pmullin@usc.edu

References

Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

Reference Type: RESULT

PMID: 11704164 (View on PubMed)

Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.

Reference Type: RESULT

PMID: 19370687 (View on PubMed)

Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.

Reference Type: RESULT

PMID: 23356673 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

Reference Type: DERIVED

PMID: 32852803 (View on PubMed)

Other Identifiers

HS-13-00740

Identifier Type: -

Identifier Source: org_study_id