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

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Oxytocin; High Risk Pregnancy; Misoprostol
• Intervention / Treatment: Drug: Oxytocin; Drug: Misoprostol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin with Mechanical Dilation; 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; Intervention; Other Names: Mechanical Dilation
Active Comparator: Misoprostol with Mechanical Dilation; 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; Control; Other Names: Mechanical Dilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: 20D.435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No