Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-29 @ 4:15 AM
Study NCT ID:
NCT07121634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011273', 'term': 'Pregnancy, Prolonged'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}, {'id': 'D020030', 'term': 'Nitric Oxide Donors'}], 'ancestors': [{'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'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'blinded assessors'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1 Arm Title: Misoprostol Group Arm Type: Experimental\n\nArm Description:\n\nParticipants in this group received 25 µg of Misoprostol (Vagiprost; ADWIA Co/Egypt) administered vaginally every 4 hours, up to a maximum of 3 doses, for cervical ripening before induction of labor.\n\nAssigned Intervention:\n\nDrug Name: Misoprostol • Other Names: Vagiprost, synthetic prostaglandin E1 Arm 2 Arm Title: Isosorbide Mononitrate Group Arm Type: Active Comparator\n\nArm Description:\n\nParticipants in this group received 40 mg of Isosorbide Mononitrate (Monomack; Mack Pharmaceutics, Jordan) administered vaginally every 4 hours, up to 3 doses, as a nitric oxide donor agent for cervical ripening.\n\nAssigned Intervention:\n\nDrug Name: Isosorbide Mononitrate\n\n• Other Names: IMN, Monomack, nitric oxide donor'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cesarean Section', 'timeFrame': 'during delivery', 'description': 'Rate of Cesarean Section Proportion of participants who underwent cesarean delivery. Unit of Measure: Percentage of participants (%)'}, {'measure': 'Postpartum Hemorrhage Unit of Measure: Number of participants', 'timeFrame': 'Delivery to 2 hours postpartum', 'description': 'Number of participants with blood loss ≥500 mL during or within 2 hours after delivery.'}, {'measure': 'abnormal fetal heart tracing during labor', 'timeFrame': 'during delivery', 'description': 'number of fetuses who develop abnormal heart tracing'}, {'measure': 'Neonatal Apgar Score <7 at 1 Minute Unit of Measure: Number of neonates', 'timeFrame': 'Time Frame: 1 minute post-delivery', 'description': 'Description: Number of neonates with Apgar score \\<7 at 1 minute after birth.'}, {'measure': 'Neonatal Apgar Score <10 at 5 Minutes', 'timeFrame': '5 minutes post-delivery', 'description': 'Number of neonates with Apgar score \\<10 at 5 minutes after birth.\n\nUnit of Measure: Number of neonates'}], 'primaryOutcomes': [{'measure': 'Cervical Ripening Success', 'timeFrame': 'Time Frame: Up to 40 hours post-intervention', 'description': 'Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate.\n\nUnit of Measure: Percentage of participants (%)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Misoprostol', 'Isosorbide Mononitrate', 'Pregnancy, Prolonged'], 'conditions': ['Cervical Ripening']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.', 'detailedDescription': 'This randomized controlled trial evaluates the effectiveness and safety of misoprostol versus isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies (≥41+0 weeks gestation). Favorable cervical status, reflected by a Bishop Score ≥6, is critical for successful vaginal delivery. Participants are low-risk pregnant women at 41+6 weeks with an unfavorable cervix. They are randomized to receive either 25 mcg of vaginal misoprostol or 40 mg of vaginal IMN, administered every 4 hours for up to 3 doses. Cervical status is assessed at regular intervals to determine the achievement of cervical ripening within 40 hours.\n\nThe primary outcome is the proportion of participants achieving a Bishop Score ≥6. Secondary outcomes include maternal parameters (labor progression, cesarean section rate, postpartum hemorrhage) and neonatal outcomes (Apgar scores, fetal heart rate tracing, and Doppler indices). The study aims to determine which agent more effectively facilitates cervical ripening and supports favorable delivery outcomes in late-term pregnancies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low-risk primigravidae\n* Singleton viable pregnancy\n* Cephalic fetal presentation\n* Confirmed gestational age ≥ 41+0/7 weeks\n* Normal fetal growth pattern\n* No signs of labor at the time of enrollment\n\nExclusion Criteria:\n\n* High-risk pregnancies\n* Body mass index (BMI) \\> 30 kg/m²\n* History of unexplained fetal death\n* Oligohydramnios or fetal distress\n* Abnormal placentation\n* Rh-negative status\n* Pre-existing medical conditions or contraindications to labor induction or study drugs\n* Fetal abnormalities\n* Malpresentation or malposition\n* Inadequate pelvimetry\n* Participants who developed fetal distress or failed to progress during induction and required emergency cesarean section'}, 'identificationModule': {'nctId': 'NCT07121634', 'briefTitle': 'Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Of Anbar'}, 'officialTitle': 'Cervical Ripening With Misoprostol Versus Isosorbide Mononitrate in Late-term Pregnancies: A Prospective Parallel -Arm Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'University of Anbar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol group', 'description': 'Misoprostol Group Arm Type: Experimental\n\nArm Description:\n\nParticipants in this group received 25 µg of Misoprostol (Vagiprost; ADWIA Co/Egypt) administered vaginally every 4 hours, up to a maximum of 3 doses, for cervical ripening before induction of labor.\n\nAssigned Intervention:\n\nDrug Name: Misoprostol\n\n• Other Names: Vagiprost, synthetic prostaglandin E1', 'interventionNames': ['Drug: Misoprostol 25 µg Vaginal']}, {'type': 'EXPERIMENTAL', 'label': 'Isosorbide Mononitrate Group', 'description': 'The Isosorbide Mononitrate group (n=40) were nitric acid donor cases applied to the posterior fornix prior to induction of labor. Isosorbide mononitrate (IMN) (Monomack; Mack Pharmaceutics; Jordan) in a vaginal dose of 40 mg was used every 4 hours (up to 3 doses).', 'interventionNames': ['Drug: Isosorbide Mononitrate']}], 'interventions': [{'name': 'Misoprostol 25 µg Vaginal', 'type': 'DRUG', 'otherNames': ['Cytotec Vagiprost PGE1 analogue'], 'description': 'The Misoprostol group (n=40) were Misoprostol cases, a synthetic PGE1 in the form of vaginal tablets of 25 µg (Vagiprost; ADWIA Co/Egypt) applied locally to the posterior fornix every 4 hours for cervical ripening before induction of labor is started (up to 3-doses).', 'armGroupLabels': ['Misoprostol group']}, {'name': 'Isosorbide Mononitrate', 'type': 'DRUG', 'otherNames': ['IMN, Monomack, Nitric oxide donor'], 'description': 'The Isosorbide Mononitrate group (n=40) were nitric acid donor cases applied to the posterior fornix prior to induction of labor. Isosorbide mononitrate (IMN) (Monomack; Mack Pharmaceutics; Jordan) in a vaginal dose of 40 mg was used every 4 hours (up to 3 doses).\n\nWomen who scored a BS of \\> 6 from the assigned time were labelled as (1), after the passage of 40 hours, while those women whose BS was less than 6 were labelled (0) for construction of the Kaplan Meier curve for both groups.', 'armGroupLabels': ['Isosorbide Mononitrate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10052', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Yarmouk', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Wassan Nori, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Mustansiriyah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raid M. Al-Ani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Raid M. Al-Ani', 'investigatorAffiliation': 'University Of Anbar'}}}}