Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-04 @ 4:24 PM
Study NCT ID:
NCT05834361
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2023-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Time Point of Carboprost Methylate Administration and Perioperative Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total adverse events', 'timeFrame': 'Baseline (Before surgery)', 'description': 'total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.'}], 'secondaryOutcomes': [{'measure': 'Numerical rating scale (NRS) before surgery', 'timeFrame': 'Baseline (Before surgery)', 'description': 'NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)'}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': '4 hours after surgery', 'description': 'The pond percentage'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Abortion, PONV(Post Operative Nausea and Vomiting)']}, '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': '30377555', 'type': 'BACKGROUND', 'citation': 'Pierce S, Bakker R, Myers DA, Edwards RK. Clinical Insights for Cervical Ripening and Labor Induction Using Prostaglandins. AJP Rep. 2018 Oct;8(4):e307-e314. doi: 10.1055/s-0038-1675351. Epub 2018 Oct 29.'}, {'pmid': '29409965', 'type': 'BACKGROUND', 'citation': 'Hwang JY, Song SH. Optimal Dose of Vaginal Misoprostol for Cervical Ripening before Hysteroscopy: A Randomized Double-Blind Study. J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1031-1034. doi: 10.1016/j.jmig.2018.01.022. Epub 2018 Jan 31.'}, {'pmid': '41088336', 'type': 'DERIVED', 'citation': 'Zhao Y, Xue W, Chen W, Zhang D. Delayed Administration of Carboprost Methylate Reduces Perioperative Complications Without Affecting Cervical Ripening Effect in Surgical Abortion: A Randomized Controlled Trial. J Obstet Gynaecol Res. 2025 Oct;51(10):e70107. doi: 10.1111/jog.70107.'}]}, 'descriptionModule': {'briefSummary': "Artificial abortion is the most widely used procedure in termination of first-trimester pregnancy. Cervical ripening before the operation guarantees operative convenience and decreases complications. An overstrained cervical dilation associates with uterine perforation, cervical laceration and cervical incompetence. To address the issue, various mechanical and pharmaceutical methods have been applied to prepare the cervix before transvaginal procedures. Prostaglandin analogues (PGs) play an important role in ripening the cervix or promoting uterine contraction in gynecology and obstetrics. As most tissues express prostaglandin receptors, vomiting, nausea, fever, diarrhea and abdominal pain can hardly be avoided with PGs administration. Longer PGs action contributes to better cervical ripening, but more uncomfortableness at the same time. These annoying symptoms may affect the participants' satisfaction and increase perioperative risks. To balance the safety and effectiveness of the surgery as well as patients' feeling, a proper timing for cervical ripening should be investigated. However, the administration timing of PGs has not reached a broad consensus, ranging from 16 hours to 2 hours before surgery. Carboprost methylate (CM), a PG-F2α analogue, has been used nationwide for cervical ripening in China. To minimize the side effects of PGs without affecting cervical ripening, the investigators intended to explore shortening the action time of CM in cervical preparation before artificial abortion. Thus, the investigators conducted this prospective cohort study and aimed to examine the efficacy of early and delayed vaginal administration of CM before surgery, and optimized both the perioperative safety and participants' convenience. The investigators hypothesize that early vaginal administration of CM would not affect the cervical ripening status, but will greatly reduce the unpleasant complications among the participants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-59\n* Signed informed consent.\n* Admitted to hospital for surgical termination of unplanned pregnancy\n* Gestational weeks range between 7 to 10\n* Average diameter of the gestational sac was no larger than 4cm\n\nExclusion Criteria:\n\n* Massive vaginal bleeding\n* Severe abdominal pain at admission (numerical rating scale, NRS\\>3)\n* Genital tract infection\n* Contraindication of PGs (including uncontrolled hypertension, asthma, glaucoma, severe heart disease or allergy to prostaglandins, etc.)\n* Prior history of vaginal delivery'}, 'identificationModule': {'nctId': 'NCT05834361', 'briefTitle': 'The Time Point of Carboprost Methylate Administration and Perioperative Complications', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion', 'orgStudyIdInfo': {'id': 'K23C0074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early administration of carboprost methylate', 'description': 'Shortening the vaginal administration time of carboprost methylate, approximately 20 minutes before the surgery. Carboprost methylate was given when patients enter the operation room area.', 'interventionNames': ['Drug: early vaginal administration of carboprost methylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'delayed administration of carboprost methylate', 'description': 'Delay the vaginal administration time of carboprost methylate, approximately 2 hours before the surgery. Carboprost methylate was given when patients were in the ward.', 'interventionNames': ['Drug: delayed vaginal administration of carboprost methylate']}], 'interventions': [{'name': 'early vaginal administration of carboprost methylate', 'type': 'DRUG', 'description': 'In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.', 'armGroupLabels': ['early administration of carboprost methylate']}, {'name': 'delayed vaginal administration of carboprost methylate', 'type': 'DRUG', 'description': 'In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.', 'armGroupLabels': ['delayed administration of carboprost methylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}