Clinical trial NCT01827995: Simplified Medical Abortion in Rural India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Low sensitivity urinary hCG
follow up
medical abortion
rural India
RCT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 731
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy
timeFrame: At 10-14 days follow up
Secondary outcomes:
measure: Safety
timeFrame: Up to 10-14 days Follow Up
Other outcomes:
measure: contraceptive uptake
timeFrame: at approx. 2 weeks after abortion (at FU)
measure: time consumption
timeFrame: at 10-14 days Follow Up
measure: Acceptability
timeFrame: at 10-14 days follow up
Locations:
city: Udaipur
country: India
facility: ARTH
state: Rajasthan
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arth
name: Sharad Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paul M, Iyengar SD, Essen B, Gemzell-Danielsson K, Iyengar K, Bring J, Klingberg-Allvin M. Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial. BMC Public Health. 2016 Oct 17;16(1):1087. doi: 10.1186/s12889-016-3726-1.
citation: Paul M, Iyengar K, Essen B, Gemzell-Danielsson K, Iyengar SD, Bring J, Soni S, Klingberg-Allvin M. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Sep 1;10(9):e0133354. doi: 10.1371/journal.pone.0133354. eCollection 2015.
citation: Iyengar K, Paul M, Iyengar SD, Klingberg-Allvin M, Essen B, Bring J, Soni S, Gemzell-Danielsson K. Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial. Lancet Glob Health. 2015 Sep;3(9):e537-45. doi: 10.1016/S2214-109X(15)00150-3.
citation: Paul M, Iyengar K, Iyengar S, Gemzell-Danielsson K, Essen B, Klingberg-Allvin M. Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India--study protocol and intervention adaptation of a randomised control trial. BMC Womens Health. 2014 Aug 15;14:98. doi: 10.1186/1472-6874-14-98.