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Completed

NCT Number: NCT03670836

Comparison of Misoprostol Ripening Efficacy With Dilapan

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.

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Key information

Conditions

Labor Onset and Length Abnormalities Induced; Birth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York Presbyterian - Allen Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Aquacryl Hydrogel

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.

Other names: Cytotec

Primary outcomes

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

    Time frame: Up to 36 hours after intervention

    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.

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

    Time frame: Up to 36 hours after intervention

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

Secondary outcomes

  1. Change in Bishop Score

    Time frame: Baseline and 12 hours after intervention

    The Bishop Score (also known as Pelvic Score) is the most commonly used method to rate the readiness of the cervix for induction of labor. The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix. It ranges from 0 to 13. Higher score is associated with increased likelihood of vaginal delivery.

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

    Time frame: Up to 24 hours after intervention

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

  3. Overall Vaginal Delivery Rate

    Time frame: Approximately up to 48 hours

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

  4. Number of Participants With Cesarean Deliveries

    Time frame: Start of cervical ripening to delivery, up to 36 hours

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

  5. Total Length of Hospital Stay

    Time frame: Up to 4 days

    This is to measure the cost-effectiveness of either Dilapan or Misoprostol for cervical ripening. Length will be measured in number of days from hospital admission until discharge.

  6. Percentage of Women Who Developed Chorioamnionitis

    Time frame: From delivery until two weeks after discharge (approximately up to 3 weeks)

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

  7. Percentage of Women Who Developed Postpartum Hemorrhage

    Time frame: From delivery until two weeks after discharge (approximately up to 3 weeks)

    This is to measure the safety of either Dilapan or Misoprostol for cervical ripening, postpartum hemorrhage is defined as estimated blood loss (EBL) > 1000cc and/or drop in Hematocrit (HCT) by 10 points.

  8. Percentage of Newborns With Apgar Score <7 at 5 Min

    Time frame: 5 minutes following birth

    This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns

  9. Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1

    Time frame: From birth until two weeks after birth

    This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns

  10. Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention

    Time frame: From birth until two weeks after birth

    This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns

  11. Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention

    Time frame: From birth until two weeks after birth

    This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Medicem International CR s.r.o.

Registry information

Official study title

Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]

Acronym: COMRED

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2018
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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