Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

NCT03976037 | Completed Early Phase 1 FDA Drug

• 1 other identifier: DDD# 604291
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Rate of Cesarean delivery

  through study completion, an average of 2 year

• Time to active labor

  through study completion, an average of 2 year

• Maternal length of stay

  through study completion, an average of 2 year

• Indication for cesarean delivery

  through study completion, an average of 2 year

• Rate of 3rd/4th degree perineal laceration

  through study completion, an average of 2 year

Study Arms (2)

Vaginal Misoprostol in combination with foley bulb

ACTIVE COMPARATOR

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

Buccal Misoprostol in combination with foley bulb

ACTIVE COMPARATOR

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

Interventions

Misoprostol DRUG

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.

Also known as: cytotec

Buccal Misoprostol in combination with foley bulb; Vaginal Misoprostol in combination with foley bulb

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Location

Related Publications (3)

• 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.

  PMID: 27824758 BACKGROUND

• 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.

  PMID: 14586350 BACKGROUND

• 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.

  PMID: 33617796 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Helen B Gomez, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: June 4, 2019
• Primary Completion: January 20, 2020
• Study Completion: February 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)