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

• ClinicalTrials.gov Identifier: NCT03976037
• Recruitment Status: Completed
• First Posted: June 5, 2019
• Last Update Posted: February 26, 2021
• Sponsor: Christiana Care Health Services
• Information provided by (Responsible Party): Helen Beatriz Gomez, Christiana Care Health Services

Tracking Information

• First Submitted Date: May 31, 2019
• First Posted Date: June 5, 2019
• Last Update Posted Date: February 26, 2021
• Actual Study Start Date: June 4, 2019
• Actual Primary Completion Date: January 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2019)

time to delivery (hours) defined [ Time Frame: through study completion, an average of 2 year ]

as time from initiation of induction method to delivery time, regardless of mode of delivery.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 4, 2019)

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

Original Secondary Outcome Measures (submitted: June 4, 2019)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Induction of Labor

Intervention

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 Name: cytotec

Study Arms

• 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.

  Intervention: Drug: Misoprostol
• 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.

  Intervention: Drug: Misoprostol

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 4, 2019): 216
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 1, 2021
• Actual Primary Completion Date: January 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03976037
• Other Study ID Numbers: DDD# 604291
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Helen Beatriz Gomez, Christiana Care Health Services
• Original Responsible Party: Same as current
• Current Study Sponsor: Christiana Care Health Services
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Helen B Gomez, MD; Christiana Care Health Services

• PRS Account: Christiana Care Health Services
• Verification Date: February 2021