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

NCT04492072 | Completed

• 1 other identifier: 20D.435
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section; Misoprostol; Oxytocin; High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• Rate of Cesarean Delivery

  Total rate of cesarean delivery

  48 hours

Secondary Outcomes (17)

• The time interval from induction-to-delivey for vaginal deliveries

  48 hours

• The number of vaginal births within 24 hours

  24 hours

• The number of misoprostol doses received by each participant

  24 hours

• The incidence of uterine tachysystole

  24 hours

• The rate of each indication for the cesarean delivery

  48 hours

Study Arms (2)

Oxytocin with Mechanical Dilation

EXPERIMENTAL

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

Misoprostol with Mechanical Dilation

ACTIVE COMPARATOR

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

Interventions

Oxytocin DRUG

Intervention

Also known as: Mechanical Dilation

Oxytocin with Mechanical Dilation

Misoprostol DRUG

Control

Also known as: Mechanical Dilation

Misoprostol with Mechanical Dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 37806650 DERIVED

MeSH Terms

Interventions

Oxytocin; Misoprostol

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 30, 2020
• Study Start: August 17, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)