Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions

Study Overview
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Brief Summary
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The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise

Detailed Description
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This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation. In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Official Title
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Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial

Conditions
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Cesarean Section, Misoprostol, Oxytocin, High Risk Pregnancy

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age > 18 years old Singleton, or twins with demise of one Cephalic presentation Intact membranes Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP) Oligohydramnios (AFI< 5cm and/or MVP <2cm) Fetal growth restriction (EFW or AC <10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal movement) prompting induction of labor Suspected placental abruption Poorly controlled pre-gestational diabetes, defined as >50% abnormal glucose values requiring increasing doses of anti-glycemic agents >34 weeks, or requiring delivery Gestational Age > 22 weeks Bishop score < 6 Exclusion Criteria: • Prior cesarean delivery Allergy to misoprostol Allergy to oxytocin Allergy to silicone/latex Contraindication to vaginal delivery including placenta or vasa previa, Placenta accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load >1000 copies/mL

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Oxytocin with Mechanical Dilation<br>If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement. If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation. | Drug: Oxytocin<br>* Intervention<br>* Other names: Mechanical Dilation;|
| Active Comparator: Misoprostol with Mechanical Dilation<br>If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur | Drug: Misoprostol<br>* Control<br>* Other names: Mechanical Dilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cesarean Delivery | Total rate of cesarean delivery | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time interval from induction-to-delivey for vaginal deliveries | Maternal outcome | 48 hours | 
| The number of vaginal births within 24 hours | Maternal outcome | 24 hours | 
| The number of misoprostol doses received by each participant | Maternal outcome | 24 hours | 
| The incidence of uterine tachysystole | Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes | 24 hours | 
| The rate of each indication for the cesarean delivery | Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc. | 48 hours | 
| The rate of operative vaginal delivery | Maternal outcome - includes forceps or vacuum assisted deliveries | 48 hours | 
| The rate of intra-amniotic infection | Maternal outcome | 48 hours | 
| The rate of postpartum hemorrhage | Maternal outcome | 24 hours | 
| The rate of Fetal heart rate abnormaliies | recurrent late decelerations, bradycardia, or prolonged deceleration | 48 hours | 
| The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection | Maternal outcome | 24 hours | 
| The rate of stillbirth | Fetal/Neonatal outcome | 48 hours | 
| The total rate of Neonatal Apgar scores less than 7 at 5 minutes | Neonatal outcome | 5 minutes | 
| The total rate of Neonatal RDS | Neonatal outcome | 96 hours | 
| The total rate of Neonatal admission to the NICU | Neonatal outcome | 96 hours | 
| The total rate of neonatal arterial umbilical blood pH < 7.1 | Neonatal outcome | 96 hours | 
| The rate of neonatal Sepsis | Neonatal outcome | 96 hours | 
| The rate of Neonatal Death | Neonatal outcome | 96 hours |