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

NCT ID: NCT04492072

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2022-05-26

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.

Conditions

Cesarean Section; Misoprostol; Oxytocin; High Risk Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Intervention

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Control

Interventions

Oxytocin

Intervention

Intervention Type: DRUG

Misoprostol

Control

Intervention Type: DRUG

Other Intervention Names

Mechanical Dilation; Mechanical Dilation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Leen Al-Hafez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

Al-Hafez L, Khanuja K, Mendez-Figueroa H, Al-Kouatly HB, Mascio DD, Chauhan SP, Berghella V. Misoprostol with balloon vs oxytocin with balloon in high-risk pregnancy induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101175. doi: 10.1016/j.ajogmf.2023.101175. Epub 2023 Oct 6.

Reference Type: DERIVED

PMID: 37806650 (View on PubMed)

Other Identifiers

20D.435

Identifier Type: -

Identifier Source: org_study_id