Clinical trial NCT03976037: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Induction of Labor
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: time to delivery (hours) defined
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Rate of Cesarean delivery
timeFrame: through study completion, an average of 2 year
measure: Time to active labor
timeFrame: through study completion, an average of 2 year
measure: Maternal length of stay
timeFrame: through study completion, an average of 2 year
measure: Indication for cesarean delivery
timeFrame: through study completion, an average of 2 year
measure: Rate of 3rd/4th degree perineal laceration
timeFrame: through study completion, an average of 2 year
measure: Rate of Maternal Blood transfusion
timeFrame: through study completion, an average of 2 year
measure: Rate of Endometritis
timeFrame: through study completion, an average of 2 year
measure: Rate of Wound separation-infection
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: Rate of Venous thromboembolism
timeFrame: through study completion, an average of 2 year
measure: Rate of Hysterectomy
timeFrame: through study completion, an average of 2 year
measure: Rate of Intensive care unit admission
timeFrame: through study completion, an average of 2 year
measure: Rate of Maternal Death
timeFrame: through study completion, an average of 2 year
measure: Rate of Chorioamnionitis
timeFrame: through study completion, an average of 2 year
measure: Rate of terbutaline use
timeFrame: through study completion, an average of 2 year
measure: Rate of Intrauterine pressure catheter use
timeFrame: through study completion, an average of 2 year
measure: Rate of Amnioinfusion
timeFrame: through study completion, an average of 2 year
measure: Rate of Analgesia use
timeFrame: through study completion, an average of 2 year
measure: Rate of Severe respiratory distress syndrome
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of Culture proven-presumed neonatal sepsis
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of Neonatal blood transfusion
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of Hypoxic ischemic encephalopathy
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of Intraventricular hemorrhage grade 3 or 4
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of Necrotizing enterocolitis
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of head cooling.
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Rate of NICU admission
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Helen B Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.