Evidence map›Paper›PMID 29073916›Full record

Trial reportTrials2017

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

Theresa A Lawrie, Ana Pilar Betrán, Mandisa Singata-Madliki, Alvaro Ciganda, G Justus Hofmeyr, José M Belizán, Tina Dannemann Purnat, Sarah Manyame, Catherine Parker, Gabriela Cormick and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 18% of its field
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
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  8. Pilot implementation ofSAGE open medicine · 2020
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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

11 authors at 4 institutions in 5 countries.

Theresa A LawrieEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, East London, South Africa. tess@lawrie.com.
Ana Pilar BetránHRP - UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Mandisa Singata-MadlikiEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, East London, South Africa.
Alvaro CigandaDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS), Emilio Ravignani 2024, Buenos Aires, Argentina.
G Justus HofmeyrEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, East London, South Africa.
José M BelizánDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS), Emilio Ravignani 2024, Buenos Aires, Argentina.
Tina Dannemann PurnatDivision of Information, Evidence, Research and Innovation, World Health Organization Regional Office for Europe, Copenhagen, Denmark.
Sarah ManyameUniversity of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Catherine ParkerEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort Hare, East London, South Africa.
Gabriela CormickDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS), Emilio Ravignani 2024, Buenos Aires, Argentina.
Calcium and Pre-eclampsia Study Group
Western Cape Department of Health · ZAInstituto de Efectividad Clínica y Sanitaria · ARUniversity of Zimbabwe · ZWWorld Health Organization Regional Office for Europe · DK

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundThe preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials.

methodsRecruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics.

resultsBetween July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization.

conclusionsIn preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low-resource settings with suboptimal medical records and other challenges. Trial planners should ensure that trial budgets cover sufficient on-site researchers with pre-trial training, and should consider using mobile phone and web-based electronic tools to optimize recruitment and retention. This should lead to greater efficiency and shorter trial durations.

trial registrationPan-African Clinical Trials Registry, Registration Number: PACTR201105000267371 . The trial was registered on 6 December 2016.

Indexed as

Dietary SupplementsPatient SelectionArgentinaCalcium CarbonateDouble-Blind MethodFemaleHumansPatient DropoutsPreconception CarePre-EclampsiaPregnancyRecurrenceRisk FactorsSample SizeSouth AfricaSurveys and QuestionnairesCalcium CarbonateCalciumPreconceptionPre-eclampsiaRandomizedRecruitmentRetention

Identifiers

PMID29073916
PMCPMC5658921
OpenAlexW2765377613

What OpenQuestion holds

Textmetadata
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.