Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal Misoprostol in combination with foley bulb<br>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<br>* 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.<br>* Other names: cytotec;|
| Active Comparator: Buccal Misoprostol in combination with foley bulb<br>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<br>* 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.<br>* Other names: cytotec;|

What is the study measuring?
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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 |