Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-01 @ 6:57 PM
Study NCT ID:
NCT01827995
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2013-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplified Medical Abortion in Rural India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059026', 'term': 'Diagnostic Self Evaluation'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 731}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2013-04-03', 'studyFirstSubmitQcDate': '2013-04-05', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'contraceptive uptake', 'timeFrame': 'at approx. 2 weeks after abortion (at FU)', 'description': 'Number of women who have started a contraceptive method or is planning to start a method'}, {'measure': 'time consumption', 'timeFrame': 'at 10-14 days Follow Up', 'description': 'Time spent for clinical visits/contacts'}, {'measure': 'Acceptability', 'timeFrame': 'at 10-14 days follow up', 'description': 'Acceptability (evaluated by a questionnaire)of home self assessment of complete pregnancy using a low sensitivity u-hCG test'}], 'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'At 10-14 days follow up', 'description': 'efficacy of self-assessment, measured as the rate of complete abortion, relative to routine follow up . The percentage of women requiring surgical intervention, extra visits and administration of additional misoprostol will be used to monitor incomplete abortion.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 10-14 days Follow Up', 'description': 'unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low sensitivity urinary hCG', 'follow up', 'medical abortion', 'rural India', 'RCT'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '27745552', 'type': 'DERIVED', 'citation': 'Paul M, Iyengar SD, Essen B, Gemzell-Danielsson K, Iyengar K, Bring J, Klingberg-Allvin M. Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial. BMC Public Health. 2016 Oct 17;16(1):1087. doi: 10.1186/s12889-016-3726-1.'}, {'pmid': '26327217', 'type': 'DERIVED', 'citation': 'Paul M, Iyengar K, Essen B, Gemzell-Danielsson K, Iyengar SD, Bring J, Soni S, Klingberg-Allvin M. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Sep 1;10(9):e0133354. doi: 10.1371/journal.pone.0133354. eCollection 2015.'}, {'pmid': '26275330', 'type': 'DERIVED', 'citation': 'Iyengar K, Paul M, Iyengar SD, Klingberg-Allvin M, Essen B, Bring J, Soni S, Gemzell-Danielsson K. Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial. Lancet Glob Health. 2015 Sep;3(9):e537-45. doi: 10.1016/S2214-109X(15)00150-3.'}, {'pmid': '25127545', 'type': 'DERIVED', 'citation': 'Paul M, Iyengar K, Iyengar S, Gemzell-Danielsson K, Essen B, Klingberg-Allvin M. Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India--study protocol and intervention adaptation of a randomised control trial. BMC Womens Health. 2014 Aug 15;14:98. doi: 10.1186/1472-6874-14-98.'}]}, 'descriptionModule': {'briefSummary': "It is estimated that around 50 000 women die every year due to consequences of unsafe abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC) would mean important improvements for the concerned women and their families (Singh, 2006) as well as for the societies at large. Recommended improvements concern increased access to the safest and most cost-effective methods such as medical abortion provided at primary level facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled trials within the field of medical abortion are conducted in high-income settings with good access to emergency health care services (Kulier et al, 2004). A simplified regime for medical abortion, which could be used at primary level facilities, would contribute to the reduction of maternal mortality and morbidity related to unsafe abortions globally. However, there is a knowledge gap in order to determine if a simplified follow up of medical abortion is equally effective as the standard procedure in a low-income setting. The results will provide evidence-based information to be used in revising training and service delivery guidelines' in order to reduce maternal mortality and morbidity in both low and high-income setting."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women presenting with a positive urine test and uterine size equivalent to or up to 9 +0 weeks (63 days) of gestation\n* opting for medical abortion and\n* residing in an area where follow-up is feasible.\n* woman agrees for a follow up contact at 10-14 days.\n\nExclusion Criteria:\n\n* women with contraindications to medical abortions,\n* haemoglobin level less than 85 (Hb \\< 85) and\n* age less than 18 years.'}, 'identificationModule': {'nctId': 'NCT01827995', 'briefTitle': 'Simplified Medical Abortion in Rural India', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'orgStudyIdInfo': {'id': 'WDuo2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Duo test', 'description': 'Self assessment', 'interventionNames': ['Other: Self assessment']}, {'type': 'OTHER', 'label': 'Routine follow up', 'description': 'Follow up in the clinic', 'interventionNames': ['Other: Routine assessment']}], 'interventions': [{'name': 'Self assessment', 'type': 'OTHER', 'otherNames': ['Duo test'], 'description': 'Intervention group: Simplified followup Mifepristone at outpatient clinic, followed by the administration of misoprostol 24-48 hours later (in the clinic or at home). The women will not return to the clinic for routine follow up visit, but are given instructions on how to use a checklist and a low sensitivity pregnancy test around day 10-14. They are asked only to return if they have any health problems or screen positively. The low sensitivity urinary-hCG (with HCG of 1000 IU/ml) test will be used. Women will be provided the pregnancy test free of cost along with a pictorial checklist. A research assistant or a nurse will explain in detail how to use the pregnancy test as well as the checklist, and provide phone numbers in case of any questions or doubts. Follow-up interviews will be conducted through home visits or phone (if woman has one) during the next 1-2 days to screen for on-going pregnancies and assess acceptability the self-assessment.', 'armGroupLabels': ['Duo test']}, {'name': 'Routine assessment', 'type': 'OTHER', 'description': 'Follow up in the clinic', 'armGroupLabels': ['Routine follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313001', 'city': 'Udaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'ARTH', 'geoPoint': {'lat': 24.58584, 'lon': 73.71346}}], 'overallOfficials': [{'name': 'Kristina Gemzell Danielsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Sharad Iyengar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kristina Gemzell Danielsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}