Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb (BEGIN)

Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.

Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.

Study Overview

• Status: Completed
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: Misoprostol

Detailed Description

This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.

This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ≥18 years of age
• full term (≥37 weeks) gestations determined by routine obstetrical guidelines
• singleton gestation in cephalic presentation
• Both nulliparous and multiparous women
• Intact membranes
• Cervical dilation ≤2cm

Exclusion Criteria:

• Any contraindication to a vaginal delivery or to misoprostol
• fetal demise
• Multifetal gestation
• prior uterine surgery, previous cesarean section
• Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
• women with HIV, and women with medical conditions requiring an assisted second stage
• Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies

As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Vaginal Misoprostol in combination with foley bulb; Women in the vaginal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of misoprostol per vagina along with the insertion of a16F Foley catheter with a stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Vaginal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.	Drug: Misoprostol; Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.; Other Names: cytotec
ACTIVE_COMPARATOR: Buccal Misoprostol in combination with foley bulb; misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.	Drug: Misoprostol; Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.; Other Names: cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to delivery (hours) defined	as time from initiation of induction method to delivery time, regardless of mode of delivery.	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Cesarean delivery	yes/no	through study completion, an average of 2 year
Time to active labor	s time from initiation of induction method to dilatation ≥6cm	through study completion, an average of 2 year
Maternal length of stay	defined as length of time from admission for induction to discharge postpartum, days	through study completion, an average of 2 year
Indication for cesarean delivery	The reason for induction: NRFHT, arrest of dilation, arrest of descent, failed IOL, other	through study completion, an average of 2 year
Rate of 3rd/4th degree perineal laceration	yes/no	through study completion, an average of 2 year
Rate of Maternal Blood transfusion	yes/no	through study completion, an average of 2 year
Rate of Endometritis	yes/no; fundal tenderness and fever that required treatment with antibiotics	through study completion, an average of 2 year
Rate of Wound separation-infection	the need for additional wound closure or the need for antibiotics	From time of delivery to time of hospital discharge; up to 6 weeks
Rate of Venous thromboembolism	yes/no	through study completion, an average of 2 year
Rate of Hysterectomy	yes/no	through study completion, an average of 2 year
Rate of Intensive care unit admission	yes/no	through study completion, an average of 2 year
Rate of Maternal Death	yes/no	through study completion, an average of 2 year
Rate of Chorioamnionitis	the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness	through study completion, an average of 2 year
Rate of terbutaline use	yes/no	through study completion, an average of 2 year
Rate of Intrauterine pressure catheter use	yes/no	through study completion, an average of 2 year
Rate of Amnioinfusion	yes/no	through study completion, an average of 2 year
Rate of Analgesia use	yes/no	through study completion, an average of 2 year
Rate of Severe respiratory distress syndrome	defined as intubation and mechanical ventilation for a minimum of 12 hours	From time of delivery to hospital discharge; up to 6 weeks
Rate of Culture proven-presumed neonatal sepsis	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of Neonatal blood transfusion	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of Hypoxic ischemic encephalopathy	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of Intraventricular hemorrhage grade 3 or 4	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of Necrotizing enterocolitis	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of head cooling.	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Rate of NICU admission	yes/no	From time of delivery to hospital discharge; up to 6 weeks

Collaborators and Investigators

• Sponsor: Christiana Care Health Services

Publications and helpful links

General Publications

• Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
• Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol. 2003 Oct;189(4):1031-5. doi: 10.1067/s0002-9378(03)00842-1.
• Gomez HB, Hoffman MK, Caplan R, Ruhstaller K, Young MHH, Sciscione AC. Buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial. Am J Obstet Gynecol. 2021 May;224(5):524.e1-524.e8. doi: 10.1016/j.ajog.2021.02.016. Epub 2021 Feb 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2019
• Primary Completion (ACTUAL): January 20, 2020
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: DDD# 604291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No