Labor Onset and Length AbnormalitiesPhase 4COMREDNCT03670836
Comparison of Misoprostol Ripening Efficacy With Dilapan
A Phase 4 study testing Dilapan and Misoprostol in people with Labor Onset and Length Abnormalities and Induced; Birth, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities, Induced; Birth
- What is being tested?
- Dilapan and Misoprostol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2018to 21 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Bishop score ≥ 6
- Major fetal congenital anomalies (as assessed by investigator)
- Premature rupture of membranes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas
Galveston, Texas, 77555
New York Presbyterian - Allen Hospital
New York, New York, 10034
About this study
Official title: Dilapan vs Misoprostol for Cervical Ripening [COMRED - 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.
Read the 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.
- Being tested
- Dilapan, Misoprostol
- Keywords
- Misoprostol, Dilapan, Induction of labor, Aquacryl hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DilapanDevice
Also called Aquacryl Hydrogel
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.
MisoprostolDrug
Also called Cytotec
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 36 hours after intervention
Secondary outcomes (11)
Change in Bishop Score
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.
Measured: Baseline and 12 hours after intervention
Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Measured: Up to 24 hours after intervention
Overall Vaginal Delivery Rate
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Measured: Approximately up to 48 hours
Number of Participants With Cesarean Deliveries
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Measured: Start of cervical ripening to delivery, up to 36 hours
Total Length of Hospital Stay
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.
Measured: Up to 4 days
Percentage of Women Who Developed Chorioamnionitis
This is to measure the safety of either Dilapan or Misoprostol for cervical ripening
Measured: From delivery until two weeks after discharge (approximately up to 3 weeks)
Percentage of Women Who Developed Postpartum Hemorrhage
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.
Measured: From delivery until two weeks after discharge (approximately up to 3 weeks)
Percentage of Newborns With Apgar Score <7 at 5 Min
This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Measured: 5 minutes following birth
Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1
This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Measured: From birth until two weeks after birth
Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention
This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Measured: From birth until two weeks after birth
Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention
This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Measured: From birth until two weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start15 Nov 2018
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicem International CR s.r.o.
- Responsible party
- Principal investigator, Rachana Gavara, Columbia University
- Investigators
- Rachana Gavara, MD, Principal investigator, rg2460@cumc.columbia.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670836
- Sponsor's protocol ID
- AAAR8566
- Acronym
- COMRED
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2018
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36996264Gavara 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.
PubMed 35675605
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]
- ClinicalTrials.gov ID
- NCT03670836
- Acronym / sponsor ID
- COMRED / AAAR8566
- Keywords
- Misoprostol, Dilapan, Induction of labor, Aquacryl hydrogel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Medicem International CR s.r.o.
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilapan group | Experimental | Device: DilapanPatients 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. |
| Misoprostol group | Experimental | Drug: MisoprostolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DilapanAlso: Aquacryl HydrogelDilapan-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. | Device | Dilapan group |
| MisoprostolAlso: Cytotec25mcg 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. | Drug | Misoprostol group |
Primary outcome
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.
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.
11 secondary outcomes
Change in Bishop Score
Time frame: Baseline and 12 hours after intervention
Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention
Time frame: Up to 24 hours after intervention
Overall Vaginal Delivery Rate
Time frame: Approximately up to 48 hours
Number of Participants With Cesarean Deliveries
Time frame: Start of cervical ripening to delivery, up to 36 hours
Total Length of Hospital Stay
Time frame: Up to 4 days
Percentage of Women Who Developed Chorioamnionitis
Time frame: From delivery until two weeks after discharge (approximately up to 3 weeks)
Percentage of Women Who Developed Postpartum Hemorrhage
Time frame: From delivery until two weeks after discharge (approximately up to 3 weeks)
Percentage of Newborns With Apgar Score <7 at 5 Min
Time frame: 5 minutes following birth
Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1
Time frame: From birth until two weeks after birth
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
Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention
Time frame: From birth until two weeks after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de 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.
- Derived from this study: PubMed 35675605Gavara 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.
- Individual participant dataSharing planned: No
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachana Gavara, MD principal investigator
rg2460@cumc.columbia.edu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dilapan and Misoprostol in people with Labor Onset and Length Abnormalities and Induced; Birth, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670836, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.