Simplified Medical Abortion in Rural India

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827995
• Other study ID #: WDuo2013
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2013
• Last updated: August 13, 2014
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian council of medical research, New Delhi
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• Routine assessment
Follow up in the clinic

Locations

Country	Name	City	State
India	ARTH	Udaipur	Rajasthan

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	contraceptive uptake	Number of women who have started a contraceptive method or is planning to start a method	at approx. 2 weeks after abortion (at FU)	No
Other	time consumption	Time spent for clinical visits/contacts	at 10-14 days Follow Up	No
Other	Acceptability	Acceptability (evaluated by a questionnaire)of home self assessment of complete pregnancy using a low sensitivity u-hCG test	at 10-14 days follow up	No
Primary	Efficacy	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.	At 10-14 days follow up	No
Secondary	Safety	unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain	Up to 10-14 days Follow Up	Yes