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

Cesarean Section Clinical Trial

— MODE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492072
• Other study ID #: 20D.435
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: May 26, 2022

Study information

• Verified date: June 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• High Risk Pregnancy
• Misoprostol
• Oxytocin

Intervention

Drug:
• Oxytocin
Intervention
• Misoprostol
Control

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cesarean Delivery	Total rate of cesarean delivery	48 hours
Secondary	The time interval from induction-to-delivey for vaginal deliveries	Maternal outcome	48 hours
Secondary	The number of vaginal births within 24 hours	Maternal outcome	24 hours
Secondary	The number of misoprostol doses received by each participant	Maternal outcome	24 hours
Secondary	The incidence of uterine tachysystole	Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes	24 hours
Secondary	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
Secondary	The rate of operative vaginal delivery	Maternal outcome - includes forceps or vacuum assisted deliveries	48 hours
Secondary	The rate of intra-amniotic infection	Maternal outcome	48 hours
Secondary	The rate of postpartum hemorrhage	Maternal outcome	24 hours
Secondary	The rate of Fetal heart rate abnormaliies	recurrent late decelerations, bradycardia, or prolonged deceleration	48 hours
Secondary	The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection	Maternal outcome	24 hours
Secondary	The rate of stillbirth	Fetal/Neonatal outcome	48 hours
Secondary	The total rate of Neonatal Apgar scores less than 7 at 5 minutes	Neonatal outcome	5 minutes
Secondary	The total rate of Neonatal RDS	Neonatal outcome	96 hours
Secondary	The total rate of Neonatal admission to the NICU	Neonatal outcome	96 hours
Secondary	The total rate of neonatal arterial umbilical blood pH < 7.1	Neonatal outcome	96 hours
Secondary	The rate of neonatal Sepsis	Neonatal outcome	96 hours
Secondary	The rate of Neonatal Death	Neonatal outcome	96 hours