Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-28 @ 9:33 AM
Study NCT ID:
NCT06502158
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone vs Misoprostol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants achieving Intended dilation', 'timeFrame': 'At time of surgery', 'description': 'The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure.'}], 'secondaryOutcomes': [{'measure': 'Cervical dilation at start of procedure', 'timeFrame': 'Start of the Procedure', 'description': 'Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics.'}, {'measure': 'Surgical time', 'timeFrame': 'Start to end of procedure, up to 4 hours', 'description': 'Total surgical time will quantified and reported by treatment arm using basic descriptive statistics.'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Start to end of procedure, up to 4 hours', 'description': 'Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics.'}, {'measure': 'Presence of Intraoperative Complications', 'timeFrame': 'From preoperative visit to discharge, up to 2 days', 'description': 'The presence of peri-operative complications, defined as instances of hemorrhage, use of uterotonic medications, passage of products of conception prior to time of surgery, instances of extramural delivery, or need for unscheduled procedures, will be summarized and reported as "Yes" or "No" using basic descriptive statistics.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'From preoperative visit to discharge, up to 2 days', 'description': 'Patient Satisfaction will be assessed by responses to a survey administered in the Postoperative Care Unit (PACU) following the procedure. The patient will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.'}, {'measure': 'Provider Satisfaction', 'timeFrame': 'From preoperative visit to discharge, up to 2 days', 'description': 'Provider Satisfaction will be assessed by responses to a survey administered following the procedure. The care provider will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procedural Abortion', 'Surgical Abortion', 'Abortion, First Trimester', 'Cervical Dilators'], 'conditions': ['Cervical Preparation']}, 'referencesModule': {'references': [{'pmid': '26683499', 'type': 'BACKGROUND', 'citation': "Allen RH, Goldberg AB. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). Contraception. 2016 Apr;93(4):277-291. doi: 10.1016/j.contraception.2015.12.001. Epub 2015 Dec 9."}, {'pmid': '20166091', 'type': 'BACKGROUND', 'citation': 'Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.'}, {'pmid': '24331860', 'type': 'BACKGROUND', 'citation': "Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11."}, {'pmid': '11035353', 'type': 'BACKGROUND', 'citation': 'Ashok PW, Flett GM, Templeton A. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study. Am J Obstet Gynecol. 2000 Oct;183(4):998-1002. doi: 10.1067/mob.2000.106767.'}, {'pmid': '22682721', 'type': 'BACKGROUND', 'citation': 'Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.'}, {'pmid': '27132200', 'type': 'BACKGROUND', 'citation': 'Ohannessian A, Baumstarck K, Maruani J, Cohen-Solal E, Auquier P, Agostini A. Mifepristone and misoprostol for cervical ripening in surgical abortion between 12 and 14 weeks of gestation: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:151-5. doi: 10.1016/j.ejogrb.2016.04.007. Epub 2016 Apr 11.'}, {'pmid': '32007418', 'type': 'BACKGROUND', 'citation': "Diedrich JT, Drey EA, Newmann SJ. Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation. Contraception. 2020 May;101(5):286-292. doi: 10.1016/j.contraception.2020.01.002. Epub 2020 Jan 31."}, {'type': 'BACKGROUND', 'citation': 'Ranji, U., Diep, K., & Salganicoff, A. (2023). Key Facts on Abortion in the United States. Retrieved from https://www.kff.org/womens-health-policy/report/key-factson- abortion-in-the-united-states/#Where-do-people-get-abortion-care.'}, {'pmid': '36404279', 'type': 'BACKGROUND', 'citation': 'Jones RK, Kirstein M, Philbin J. Abortion incidence and service availability in the United States, 2020. Perspect Sex Reprod Health. 2022 Dec;54(4):128-141. doi: 10.1363/psrh.12215. Epub 2022 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.', 'detailedDescription': "Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experiences. Furthermore, using misoprostol can pose logistical challenges in hospital-based main operating room environments, where abortions occur concurrently with all other surgical cases. Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration, which can pose logistical challenges.\n\nSeveral studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.\n\nWhile most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English or Spanish-speaking\n* Capacity to consent\n* Seeking induced abortion of a singleton pregnancy\n* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)\n\nExclusion Criteria:\n\n* History of more than two prior Cesarean deliveries\n* Sonographic evidence of placenta previa\n* Sonographic concern for morbidly adherent placenta\n* Prior obstetric hemorrhage requiring transfusion\n* Obstructive cervical or lower uterine segment fibroid\n* Current therapeutic anticoagulation use\n* Cerclage in situ\n* History of more than one prior cervical excisional procedure\n* BMI greater than 50 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT06502158', 'briefTitle': 'Mifepristone vs Misoprostol', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': "Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial", 'orgStudyIdInfo': {'id': '2024-15999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone', 'description': 'Patients will be randomized to Mifepristone-alone in a 1:1 manner prior to procedural abortions. A paracervical block of 20 cubic centimeters (cc) 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.', 'interventionNames': ['Drug: Mifepristone']}, {'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'description': 'Patients will be randomized to Misoprostol-alone in a 1:1 ratio prior to procedural abortions. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': '200 milligrams (mg)', 'armGroupLabels': ['Mifepristone']}, {'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': '600 micrograms (ug)', 'armGroupLabels': ['Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Fletcher, MD, MPH', 'role': 'CONTACT', 'email': 'lfletcher@montefiore.org', 'phone': '516-587-3297'}, {'name': 'Antoinette Danvers, MD, MSCR, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Laura Fletcher, MD, MPH', 'role': 'CONTACT', 'email': 'lfletcher@montefiore.org', 'phone': '516-587-3297'}, {'name': 'Antoinette Danvers, MD, MSCR, MBA', 'role': 'CONTACT', 'email': 'adanvers@montefiore.org', 'phone': '718-405-8260'}], 'overallOfficials': [{'name': 'Antoinette Danvers, MD, MSCR, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}