Comparison of Misoprostol Ripening Efficacy With Dilapan

NCT ID: NCT03670836

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2021-07-21

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.

Detailed Description

In developed nations 25 % of pregnant women undergo labor induction for various indications. Likelihood of vaginal delivery depends on the degree of ripeness of cervix. Majority of women undergoing induction of labor are candidates for cervical ripening. Dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. It has been proven safe for use for induction of Labor (IOL) at term. Misoprostol is a synthetic prostaglandin E1 analogue, widely used for cervical ripening and IOL in United States and is considered as standard of care.

This is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing IOL at >37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive Dilapan or Misoprostol for cervical ripening.

After randomization all participants will undergo assessment as per standard of care. Participants will have either 1-5 Dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. Participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. A diagnosis of failed IOL will be made if patient does not go into active labor within 24 hours after initiation of Oxytocin and Artificial Rupture Of Membranes (AROM). Intrapartum management will be according to institutional guidelines. All participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction.

Conditions

Labor Onset and Length Abnormalities; Induced; Birth

Study Design

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

Study Groups

Dilapan group

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.

Group Type: EXPERIMENTAL

Dilapan

Intervention Type: 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.

Misoprostol group

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.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: 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.

Interventions

Dilapan

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.

Intervention Type: DEVICE

Misoprostol

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.

Intervention Type: DRUG

Other Intervention Names

Aquacryl Hydrogel; Cytotec

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Live fetus with in cephalic presentation

3. Singleton pregnancy

4. Able to provide informed consent for participation in the study

Exclusion Criteria

1. Contraindication for vaginal delivery

2. Age less than 18 years

3. Prior uterine scar from a cesarean section or myomectomy

4. Patients who have HELLP syndrome or eclampsia

5. Active genital herpes at the time of labor induction

6. Complex medical problems that may require assistance with second stage of labor

7. Bishop score ≥ 6

8. Major fetal congenital anomalies (as assessed by investigator)

9. Premature rupture of membranes

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medicem International CR s.r.o.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rachana Gavara

Assistant Professor of Obstetrics and Gynecology at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachana Gavara, MD

Role: PRINCIPAL_INVESTIGATOR

rg2460@cumc.columbia.edu

Locations

New York Presbyterian - Allen Hospital

New York, New York, United States

University of Texas

Galveston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35675605 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AAAR8566

Identifier Type: -

Identifier Source: org_study_id