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| Name | Class |
|---|---|
| Medicem International CR s.r.o. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachana Gavara, MD | rg2460@cumc.columbia.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian - Allen Hospital | New York | New York | 10034 | United States | ||
| University of Texas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | 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. | |
| 35675605 | 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. |
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A total of 306 participants were needed , 153 in each group, to evaluate the primary outcome with 85% power to confirm the noninferiority with one sided confidence level of 97.5%
A total of 1755 women presenting for Induction of labor to labor and delivery units were screened for eligibility at Columbia University Medical Center and UTMB Texas. 307 were enrolled and randomized, 154 to Dilapan and 153 to Oral Misoprostol group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol Group- 153 | 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. 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. |
| FG001 | Dilapan Group 154 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intent-to-treat Population (ITT) |
|
| ||||||||||||||||||
| Per Protocol Population (PP) |
|
Baseline Characteristics were analyzed in the intent to treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 36 hours after intervention |
|
Data was collected from the time of randomization to 2 weeks after delivery for the enrolled subjects and their neonates .
A serious event is defined a new condition that develops during the course of study and will require significantly higher level of care like transfer to ICU for blood transfusion of multiple units .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Postpartum hemorrhag | Systematic Assessment | Blood loss of more than 1000cc immediately after delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| uterine tachysystole | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Too frequent uterine contractions during labor induction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachana Gavara | Columbia University Medical center | 914-356-2730 | rg2460@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2020 | Jun 18, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2021 | Jul 6, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| 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. |
|
|
| 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 | Up to 24 hours after intervention |
| Overall Vaginal Delivery Rate | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening | 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 | 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. | Up to 4 days |
| Percentage of Women Who Developed Chorioamnionitis | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening | 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. | 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 | 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 | 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 | 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 | From birth until two weeks after birth |
| Galveston |
| Texas |
| 77555 |
| United States |
| NOT COMPLETED |
|
|
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gestational age at randomization < 39 weeks | Count of Participants | Participants |
|
| Parity at randomization- Nulliparous/ multiparous | Count of Participants | Participants |
|
| BMI at randomization | Mean | Standard Deviation | kg/m^2 |
|
| GBS positive status | Count of Participants | Participants |
|
| Indication for induction - Diabetes | Count of Participants | Participants |
|
| Hypertensive disorders of pregnancy | Count of Participants | Participants |
|
| Post term pregnancy | Count of Participants | Participants |
|
| Fetal growth restriction | Count of Participants | Participants |
|
| Oligohydramnios | Count of Participants | Participants |
|
| Cholestasis | Count of Participants | Participants |
|
| Elective induction | Number of participants who underwent elective induced labor | Count of Participants | Participants |
|
| OG001 | 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. 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. |
|
|
| Primary | 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. | The Per Protocol (PP) population is a subset of ITT population. PP population is comprised of participants who completed the treatment originally allocated with complete adherence to the protocol. | Posted | Count of Participants | Participants | Up to 36 hours after intervention |
|
|
|
| Secondary | 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. | Intent to treat population | Posted | Median | Full Range | score on a scale | Baseline and 12 hours after intervention |
|
|
|
| Secondary | 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 | Intent to treat population | Posted | Count of Participants | Participants | Up to 24 hours after intervention |
|
|
|
| Secondary | Overall Vaginal Delivery Rate | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening | Intent to treat population | Posted | Count of Participants | Participants | Approximately up to 48 hours |
|
|
|
| Secondary | Number of Participants With Cesarean Deliveries | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening | ITT population | Posted | Count of Participants | Participants | Start of cervical ripening to delivery, up to 36 hours |
|
|
|
| Secondary | 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. | Intent to treat population | Posted | Mean | Standard Deviation | hours | Up to 4 days |
|
|
|
| Secondary | Percentage of Women Who Developed Chorioamnionitis | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening | Intent to treat population | Posted | Count of Participants | Participants | From delivery until two weeks after discharge (approximately up to 3 weeks) |
|
|
|
| Secondary | 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. | Intent to treat population | Posted | Count of Participants | Participants | From delivery until two weeks after discharge (approximately up to 3 weeks) |
|
|
|
| Secondary | 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 | Intent to treat population | Posted | Count of Participants | Participants | 5 minutes following birth |
|
|
|
| Secondary | 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 | Intent to treat population | Posted | Count of Participants | Participants | From birth until two weeks after birth |
|
|
|
| Secondary | 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 | Intent to treat population | Posted | Count of Participants | Participants | From birth until two weeks after birth |
|
|
|
| Secondary | 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 | Intent to treat population | Posted | Count of Participants | Participants | From birth until two weeks after birth |
|
|
|
| 0 |
| 151 |
| 1 |
| 151 |
| 39 |
| 151 |
| EG001 | 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. 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. | 0 | 152 | 3 | 152 | 81 | 152 |
|
|
| uterine tachy systole with abnormal fetal heart tracing | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |