Simplified Medical Abortion in Rural India

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Pregnancy

Treatments: Other: Routine assessment; Other: Self assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01827995

WDuo2013

Details and patient eligibility

About

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.

Enrollment: 731 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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731 participants in 2 patient groups

Duo test

Other group

Description:

Self assessment

Treatment:

Other: Self assessment

Routine follow up

Other group

Description:

Follow up in the clinic

Treatment:

Other: Routine assessment