Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Study Overview
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Brief Summary
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This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 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 either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Official Title
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Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Procedure: amniotomy
* Device: Foley Catheter
* 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 Bishop score of ≤6 and cervical dilation ≤2cm Exclusion Criteria: Any contraindication to a vaginal delivery or to misoprostol fetal demise Multifetal gestation major fetal anomaly prior uterine surgery, previous cesarean section women with HIV, hepatitis C, hepatitis B, 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.

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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No

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: Early Amniotomy<br>Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen. | Procedure: amniotomy<br>* Artificially rupturing membranes<br>Device: Foley Catheter<br>* Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.<br>Drug: Misoprostol<br>* Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.<br>|
| Active Comparator: Delayed Amniotomy<br>Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given. | Procedure: amniotomy<br>* Artificially rupturing membranes<br>Device: Foley Catheter<br>* Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.<br>Drug: Misoprostol<br>* Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to delivery | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery. | Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery rate | binary; yes/no | At time of delivery | 
| Time to vaginal delivery | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery | At time of delivery | 
| Maternal length of stay | time from admission to discharge | through study completion, an average of 4 days | 
| Indication for cesarean delivery | discrete | At time of delivery | 
| Chorioamnionitis | defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness | At time of delivery | 
| 3rd/4th degree perineal laceration | binary; yes/no | at time of delivery | 
| Blood transfusion | binary; yes/no | through study completion, an average of 1 year | 
| Endometritis | binary; yes/no | From time of delivery to time of hospital discharge; up to 6 weeks | 
| Wound separation-infection | binary, yes/no; defined by the need for additional wound closure or the need for antibiotics | through study completion, an average of 1 year | 
| Neonatal death | binary, yes/no | through study completion, an average of 1 year |