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Trial record 1 of 1 for:    NCT01827995
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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

Tracking Information
First Submitted Date  ICMJE April 3, 2013
First Posted Date  ICMJE April 10, 2013
Last Update Posted Date August 15, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 15, 2013)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: April 5, 2013)
  • contraceptive uptake [ Time Frame: at approx. 2 weeks after abortion (at FU) ]
    Numer 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
 
Descriptive Information
Brief Title  ICMJE Simplified Medical Abortion in Rural India
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • 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
  • Other: Routine assessment
    Follow up in the clinic
Study Arms  ICMJE
  • Duo test
    Self assessment
    Intervention: Other: Self assessment
  • Routine follow up
    Follow up in the clinic
    Intervention: Other: Routine assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2014)
731
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
716
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827995
Other Study ID Numbers  ICMJE WDuo2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristina Gemzell Danielsson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristina Gemzell Danielsson, MD, PhD Karolinska Institutet
Principal Investigator: Sharad Iyengar, MD Arth
PRS Account Karolinska Institutet
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP