Evidence map›Paper›PMID 26327217›Full record

Trial reportPloS one2015

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.

Mandira Paul, Kirti Iyengar, Birgitta Essén, Kristina Gemzell-Danielsson, Sharad D Iyengar, Johan Bring, Sunita Soni, Marie Klingberg-Allvin

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01827995 (Simplified Medical Abortion in Rural India), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01827995 phase4completednot on this map

Simplified Medical Abortion in Rural India

TypeinterventionalSponsorKarolinska InstitutetRan2013 to 2014Enrolled731ConditionsPregnancyArmsSelf assessment, Routine assessment
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. How task-sharing in abortion care became the norm in Sweden: A case study of historic and current determinants and events.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2020
    Article
  7. Preimplantation genetic testing to reduce preterm births in assisted reproductive technology.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2020
    Review
  8. Article
  9. Article
  10. Telehealth Interventions Designed for Women: an Evidence Map.Journal of general internal medicine · 2018
    Review
  11. A research agenda for moving early medical pregnancy termination over the counter.BJOG : an international journal of obstetrics and gynaecology · 2017
    Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mandira PaulDepartment of Women's and Children's health, Uppsala University, Uppsala, Sweden.
Kirti IyengarDepartment of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden; Action Research & Training for Health (ARTH), Udaipur, Rajasthan, India.
Birgitta EssénDepartment of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden.
Kristina Gemzell-DanielssonDepartment of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden.
Sharad D IyengarAction Research & Training for Health (ARTH), Udaipur, Rajasthan, India.
Johan BringStatisticon, Stockholm, Sweden.
Sunita SoniAction Research & Training for Health (ARTH), Udaipur, Rajasthan, India.
Marie Klingberg-AllvinDepartment of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden; School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education.

objectiveTo investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India.

designSecondary outcome of a randomised, controlled, non-inferiority trial.

settingOutpatient primary health care clinics in rural and urban Rajasthan, India. POPULATION: Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85 mg/l and were below 18 years.

methodsAbortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible.

main outcome measuresWomen's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups.

results731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001).

conclusionHome-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women's preference should be offered to foster women's reproductive autonomy.

trial registrationClinicalTrials.gov NCT01827995.

Indexed as

Developing CountriesHome Care ServicesPatient SatisfactionAbortion, InducedAdolescentAdultFemaleHumansIndiaMiddle AgedPatient Acceptance of Health CarePregnancyYoung Adult

Identifiers

PMID26327217
PMCPMC4556554

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.