Evidence map›Paper›PMID 30894167›Full record

ArticleBMC pregnancy and childbirth2019

Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

Thaís M Monteiro, Leila Katz, Silvana F Bento, Melania M Amorim, Patrícia C Moriel, Rodolfo C Pacagnella

Abstract read
In one paragraph

Article in BMC pregnancy and childbirth, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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  6. An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study.Health expectations : an international journal of public participation in health care and health policy · 2020
    Trial
  7. Article
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  9. Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study.BJOG : an international journal of obstetrics and gynaecology · 2025
    Article
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  11. Article
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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

6 authors.

Thaís M MonteiroInstituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.
Leila KatzInstituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil. katzleila@gmail.com.
Silvana F BentoProf. Dr. José A Pinotti Women's Hospital, Center of Integral Services for the Health of Women (CAISM), University of Campinas (UNICAMP), Campinas, SP, Brazil.
Melania M AmorimInstituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.
Patrícia C MorielInstituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.
Rodolfo C PacagnellaSchool of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial.

methodsThe women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made.

resultsOverall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system.

conclusionsThe decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.

Indexed as

AdultClinical Trials as TopicCross-Sectional StudiesDecision MakingFemaleHumansPregnancyPregnant PeoplePremature BirthQualitative ResearchResearch SubjectsClinical trialPregnancyPremature delivery

Identifiers

PMID30894167
PMCPMC6425624

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.