Simplified Medical Abortion in Rural India

NCT01827995 | Completed Phase 4 DMC

• 1 other identifier: WDuo2013
• Study Type: interventional
• Target: 731
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Low sensitivity urinary hCG; follow up; medical abortion; rural India; RCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety

  Up to 10-14 days Follow Up

Other Outcomes (3)

• contraceptive uptake

  at approx. 2 weeks after abortion (at FU)

• time consumption

  at 10-14 days Follow Up

• Acceptability

  at 10-14 days follow up

Study Arms (2)

Duo test

OTHER

Self assessment

Other: Self assessment

Routine follow up

OTHER

Follow up in the clinic

Other: Routine assessment

Interventions

Self assessment OTHER

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.

Also known as: Duo test

Duo test

Routine assessment OTHER

Follow up in the clinic

Routine follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• women with contraindications to medical abortions,
• haemoglobin level less than 85 (Hb \< 85) and
• age less than 18 years.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

ARTH

Udaipur, Rajasthan, 313001, India

Location

Related Publications (4)

• 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.

  PMID: 27745552 DERIVED

• 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.

  PMID: 26327217 DERIVED

• 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.

  PMID: 26275330 DERIVED

• 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.

  PMID: 25127545 DERIVED

MeSH Terms

Interventions

Diagnostic Self Evaluation

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kristina Gemzell Danielsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Sharad Iyengar, MD

  Arth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

IN (1)