Comparison of Misoprostol Ripening Efficacy With Dilapan

NCT03670836 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 1 other identifier: AAAR8566
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.

Conditions

Labor Onset and Length Abnormalities; Induced; Birth

Keywords

Misoprostol; Dilapan; Induction of labor; Aquacryl hydrogel

Outcome Measures

Primary Outcomes (2)

• Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population

  This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. Intent-to-treat Population (ITT) includes all patients that were randomized into the study. ITT participants will be analyzed in accordance with their randomized study treatment (i.e. in the treatment group they were originally allocated, regardless of treatment actually received). ITT will be used for evaluation of the baseline characteristics and as the primary population for efficacy assessments.

  Up to 36 hours after intervention

• Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population

  This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening.

  Up to 36 hours after intervention

Secondary Outcomes (11)

• Change in Bishop Score

  Baseline and 12 hours after intervention

• Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention

  Up to 24 hours after intervention

• Overall Vaginal Delivery Rate

  Approximately up to 48 hours

• Number of Participants With Cesarean Deliveries

  Start of cervical ripening to delivery, up to 36 hours

• Total Length of Hospital Stay

  Up to 4 days

Study Arms (2)

Dilapan group

EXPERIMENTAL

Patients who are randomized to receive Dilapan, will have 3-5 rods of Dilapan-S® inserted in their cervix by the supervising provider, under aseptic precautions with a speculum exam, either digitally or using a sponge forceps, as per manufacturer's recommendations. The Bishop score at the time of eligibility assessment and number of rods inserted will be recorded. Dilapan will be left in cervix for 12 hours. Patients will be allowed to ambulate, shower and have light meals as long as they meet the criteria based on institutional guidelines for intermittent fetal heart monitoring. "Nothing per vagina" including douching and no bathing is allowed.

Device: Dilapan

Misoprostol group

EXPERIMENTAL

Patients who are randomized to Misoprostol group, after the baseline assessment and a reassuring cardiotocograms (CTG) monitoring for 20 minutes to a maximum of 6 doses. All subjects will have continuous fetal monitoring. A dose will be held if patient is noted to have uterine tachysystole, hyperstimulation, fetal heart tracing abnormalities or 3 or more painful uterine contractions over a period of 10 minutes (indicating onset of labor). Administration of Misoprostol will be done by the nurse assigned to the patient.

Drug: Misoprostol

Interventions

Dilapan DEVICE

Dilapan-S® is a mechanical method for cervical ripening using rods made of a patented hydrogel Aquacryl, it is marketed in form of rods of 3 and 4 mm diameter. It is FDA approved for cervical ripening.

Also known as: Aquacryl Hydrogel

Dilapan group

Misoprostol DRUG

25mcg of Misoprostol will be administered orally every 2 hours (maximum of 6 doses) Misoprostol is a prostaglandin E1 analog approved for treatment and prevention of gastric ulcers. The use of Misoprostol appears to be safe and effective for induction of labor when used in low dose.

Also known as: Cytotec

Misoprostol group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks)
• Live fetus with in cephalic presentation
• Singleton pregnancy
• Able to provide informed consent for participation in the study

You may not qualify if:

• Contraindication for vaginal delivery
• Age less than 18 years
• Prior uterine scar from a cesarean section or myomectomy
• Patients who have HELLP syndrome or eclampsia
• Active genital herpes at the time of labor induction
• Complex medical problems that may require assistance with second stage of labor
• Bishop score ≥ 6
• Major fetal congenital anomalies (as assessed by investigator)
• Premature rupture of membranes

Sponsors & Collaborators

• Columbia University: lead
• Medicem International CR s.r.o.: collaborator

Study Sites (2)

New York Presbyterian - Allen Hospital

New York, New York, 10034, United States

Location

University of Texas

Galveston, Texas, 77555, United States

Location

Related Publications (2)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

• Gavara R, Saad AF, Wapner RJ, Saade G, Fu A, Barrow R, Nalgonda S, Bousleiman S, Almonte C, Alnafisee S, Holman A, Burgansky A, Heikkila P. Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1083-1091. doi: 10.1097/AOG.0000000000004799. Epub 2022 May 2.

  PMID: 35675605 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Rachana Gavara
• Organization: Columbia University Medical center

rg2460@cumc.columbia.edu

914-356-2730

Study Officials

• Rachana Gavara, MD

  rg2460@cumc.columbia.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology at the Columbia University Medical Center

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: November 15, 2018
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)