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PregnancyPhase 4NCT01827995

Simplified Medical Abortion in Rural India

A Phase 4 study testing Self assessment and Routine assessment in people with Pregnancy, run by Karolinska Institutet at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy
What is being tested?
Self assessment and Routine assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
1 siteIndia
Study dates
Apr 2013to Jun 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • ARTH

    Udaipur, Rajasthan, 313001

Other trials in India

About this study

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
Being tested
Self assessment, Routine assessment
Keywords
Low sensitivity urinary hCG, follow up, medical abortion, rural India, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self assessmentOther

    Also called Duo test

    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.

  • Routine assessmentOther

    Follow up in the clinic

Study groups in NCT01827995
Study groupRoleWhat they receive
Duo testOtherSelf assessment
Receives: Other: Self assessment
Routine follow upOtherFollow up in the clinic
Receives: Other: Routine assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 10-14 days follow up

Secondary outcomes (1)

  1. Safety

    unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain

    Measured: Up to 10-14 days Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827995
Sponsor's protocol ID
WDuo2013
Status last verified
Aug 2014
First submitted
3 Apr 2013
Last updated
15 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27745552

  • 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.

    PubMed 26327217

  • 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.

    PubMed 26275330

  • 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.

    PubMed 25127545

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Self assessment and Routine assessment in people with Pregnancy, run by Karolinska Institutet at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (time frame: At 10-14 days follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01827995, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.

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