Simplified Medical Abortion in Rural India

Phase 4

Completed

• Conditions: Pregnancy
• Interventions: Other: Routine assessment; Other: Self assessment

• Registration Number: NCT01827995
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 731

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine follow up	Routine assessment	Follow up in the clinic
Duo test	Self assessment	Self assessment

Primary Outcome Measures

Name	Time	Method
Efficacy	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

Name	Time	Method
Safety	Up to 10-14 days Follow Up	unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain

Trial Locations

Locations (1)

ARTH; 🇮🇳 Udaipur, Rajasthan, India