ARTH
Udaipur, Rajasthan, 313001, India
NCT Number: NCT01827995
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.
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Notify Me18 year and older
Female
Interventional
Phase 4
Udaipur, Rajasthan, 313001, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Duo test
Follow up in the clinic
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.
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
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 frame: at 10-14 days Follow Up
Time spent for clinical visits/contacts
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
Karolinska Institutet
Other
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