Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

Induction of Labor Clinical Trial

— BEGIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976037
• Other study ID #: DDD# 604291
• Status: Completed
• Phase: Early Phase 1
• Start date: June 4, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: February 1, 2021
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Cesarean delivery	yes/no	through study completion, an average of 2 year
Secondary	Time to active labor	s time from initiation of induction method to dilatation =6cm	through study completion, an average of 2 year
Secondary	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
Secondary	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
Secondary	Rate of 3rd/4th degree perineal laceration	yes/no	through study completion, an average of 2 year
Secondary	Rate of Maternal Blood transfusion	yes/no	through study completion, an average of 2 year
Secondary	Rate of Endometritis	yes/no; fundal tenderness and fever that required treatment with antibiotics	through study completion, an average of 2 year
Secondary	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
Secondary	Rate of Venous thromboembolism	yes/no	through study completion, an average of 2 year
Secondary	Rate of Hysterectomy	yes/no	through study completion, an average of 2 year
Secondary	Rate of Intensive care unit admission	yes/no	through study completion, an average of 2 year
Secondary	Rate of Maternal Death	yes/no	through study completion, an average of 2 year
Secondary	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
Secondary	Rate of terbutaline use	yes/no	through study completion, an average of 2 year
Secondary	Rate of Intrauterine pressure catheter use	yes/no	through study completion, an average of 2 year
Secondary	Rate of Amnioinfusion	yes/no	through study completion, an average of 2 year
Secondary	Rate of Analgesia use	yes/no	through study completion, an average of 2 year
Secondary	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
Secondary	Rate of Culture proven-presumed neonatal sepsis	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of Neonatal blood transfusion	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of Hypoxic ischemic encephalopathy	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of Intraventricular hemorrhage grade 3 or 4	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of Necrotizing enterocolitis	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of head cooling.	yes/no	From time of delivery to hospital discharge; up to 6 weeks
Secondary	Rate of NICU admission	yes/no	From time of delivery to hospital discharge; up to 6 weeks