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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
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Self assessment Other: Routine assessment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
Allocation: Randomized
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

Arm Intervention/treatment
Duo test
Self assessment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. time consumption [ Time Frame: at 10-14 days Follow Up ]
    Time spent for clinical visits/contacts

  3. 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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • women with contraindications to medical abortions,
  • haemoglobin level less than 85 (Hb < 85) and
  • age less than 18 years.

Information from the National Library of Medicine

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


Locations
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India
ARTH
Udaipur, Rajasthan, India, 313001
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Kristina Gemzell Danielsson, MD, PhD Karolinska Institutet
Principal Investigator: Sharad Iyengar, MD Arth
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01827995    
Other Study ID Numbers: WDuo2013
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
Low sensitivity urinary hCG
follow up
medical abortion
rural India
RCT