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Comparison of Misoprostol Ripening Efficacy With Dilapan (COMRED)

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ClinicalTrials.gov Identifier: NCT03670836
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Medicem International CR s.r.o.
Information provided by (Responsible Party):
Rachana Gavara, Columbia University

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.

Condition or disease Intervention/treatment Phase
Labor Onset and Length Abnormalities Induced; Birth Device: Dilapan Drug: Misoprostol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: 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.
Device: 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.
Other Name: Aquacryl Hydrogel

Experimental: 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.
Drug: 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.

Other Name: Cytotec




Primary Outcome Measures :
  1. Proportion of women achieving vaginal delivery [ Time Frame: Up to 36 hours after intervention ]
    This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening


Secondary Outcome Measures :
  1. Change in Bishop score [ Time Frame: At 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. Rate of cesarean deliveries [ Time Frame: Approximately up to 48 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 endometritis within 14 days of intervention [ 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

  8. 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.

  9. Percentage of newborns with Apgar score <7 at 5 min [ 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 cord arterial blood potential hydrogen (pH) < 7 [ 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 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670836


Contacts
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Contact: Rachana Gavara, MD 212-304-6929 rg2460@cumc.columbia.edu
Contact: Barouyr Ajemian, MD 646-891-7934 ba2532@cumc.columbia.edu

Locations
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United States, New York
New York Presbyterian - Allen Hospital Recruiting
New York, New York, United States, 10034
Contact: Barouyr Ajemian, MD    646-891-7934    ba2532@cumc.columbia.edu   
Principal Investigator: Rachana Gavara, MD         
Sponsors and Collaborators
Columbia University
Medicem International CR s.r.o.
Investigators
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Principal Investigator: Rachana Gavara, MD rg2460@cumc.columbia.edu

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Responsible Party: Rachana Gavara, Assistant Professor of Obstetrics and Gynecology at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT03670836     History of Changes
Other Study ID Numbers: AAAR8566
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rachana Gavara, Columbia University:
Misoprostol
Dilapan
Induction of labor
Aquacryl hydrogel
Additional relevant MeSH terms:
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Congenital Abnormalities
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics