Simplified Medical Abortion in Rural India

• ClinicalTrials.gov Identifier: NCT01827995
• Recruitment Status: Completed
• First Posted: April 10, 2013
• Last Update Posted: August 15, 2014
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Kristina Gemzell Danielsson, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy	Other: Self assessment; Other: Routine assessment	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 731 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Study Start Date: April 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Duo test; Self assessment	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.; Other Name: Duo test
Routine follow up; Follow up in the clinic	Other: Routine assessment; Follow up in the clinic

Outcome Measures

Primary Outcome Measures :

1. Efficacy [ Time Frame: 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 :

1. Safety [ Time Frame: Up to 10-14 days Follow Up ]
   unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain

Other Outcome Measures:

1. contraceptive uptake [ Time Frame: at approx. 2 weeks after abortion (at FU) ]
   Number of women who have started a contraceptive method or is planning to start a method
2. time consumption [ Time Frame: at 10-14 days Follow Up ]
   Time spent for clinical visits/contacts
3. Acceptability [ Time Frame: at 10-14 days follow up ]
   Acceptability (evaluated by a questionnaire)of home self assessment of complete pregnancy using a low sensitivity u-hCG test

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

India

ARTH

Udaipur, Rajasthan, India, 313001

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Kristina Gemzell Danielsson, MD, PhD; Karolinska Institutet
• Principal Investigator: Sharad Iyengar, MD; Arth

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

• Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01827995
• Other Study ID Numbers: WDuo2013
• First Posted: April 10, 2013
• Last Update Posted: August 15, 2014
• Last Verified: August 2014

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:

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