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

Not Applicable

Completed

• Conditions: Cesarean Section; Oxytocin; Misoprostol; High Risk Pregnancy
• Interventions: Drug: Oxytocin; Drug: Misoprostol

• Registration Number: NCT04492072
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-08-17
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin with Mechanical Dilation	Oxytocin	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.
Misoprostol with Mechanical Dilation	Misoprostol	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

Primary Outcome Measures

Name	Time	Method
Rate of Cesarean Delivery	48 hours	Total rate of cesarean delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States