Simplified Medical Abortion in Rural India
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|ClinicalTrials.gov Identifier: NCT01827995|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : August 15, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Other: Self assessment Other: Routine assessment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||731 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
Other: Self assessment
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.
Other Name: Duo test
Routine follow up
Follow up in the clinic
Other: Routine assessment
Follow up in the clinic
- Efficacy [ Time Frame: At 10-14 days follow up ]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.
- Safety [ Time Frame: Up to 10-14 days Follow Up ]unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain
- contraceptive uptake [ Time Frame: at approx. 2 weeks after abortion (at FU) ]Number of women who have started a contraceptive method or is planning to start a method
- time consumption [ Time Frame: at 10-14 days Follow Up ]Time spent for clinical visits/contacts
- Acceptability [ Time Frame: at 10-14 days follow up ]Acceptability (evaluated by a questionnaire)of home self assessment of complete pregnancy using a low sensitivity u-hCG test
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- women presenting with a positive urine test and uterine size equivalent to or up to 9 +0 weeks (63 days) of gestation
- opting for medical abortion and
- residing in an area where follow-up is feasible.
- woman agrees for a follow up contact at 10-14 days.
- women with contraindications to medical abortions,
- haemoglobin level less than 85 (Hb < 85) and
- age less than 18 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827995
|Udaipur, Rajasthan, India, 313001|
|Principal Investigator:||Kristina Gemzell Danielsson, MD, PhD||Karolinska Institutet|
|Principal Investigator:||Sharad Iyengar, MD||Arth|
|Responsible Party:||Kristina Gemzell Danielsson, Professor, Karolinska Institutet|
|Other Study ID Numbers:||
|First Posted:||April 10, 2013 Key Record Dates|
|Last Update Posted:||August 15, 2014|
|Last Verified:||August 2014|
Low sensitivity urinary hCG