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Randomized Controlled Trial
. 2017 Oct 26;18(1):500.
doi: 10.1186/s13063-017-2220-0.

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

Theresa A Lawrie  1   2 , Ana Pilar Betrán  3 , Mandisa Singata-Madliki  4 , Alvaro Ciganda  5 , G Justus Hofmeyr  4 , José M Belizán  5 , Tina Dannemann Purnat  6 , Sarah Manyame  7 , Catherine Parker  4 , Gabriela Cormick  5 ; Calcium and Pre-eclampsia Study Group
Affiliations
Randomized Controlled Trial

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

Theresa A Lawrie et al. Trials. .

Abstract

Background: The 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.

Methods: Recruiters 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.

Results: Between 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.

Conclusions: In 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 registration: Pan-African Clinical Trials Registry, Registration Number: PACTR201105000267371 . The trial was registered on 6 December 2016.

Keywords: Calcium; Pre-eclampsia; Preconception; Randomized; Recruitment; Retention.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for the trial was obtained from the Human Research Ethics Committee of the University of the Witwatersrand, Johannesburg (certificate number M10977), the Faculty of Health Sciences Human Research Ethics Committee, Cape Town (HREC 457/2010), Health Research Ethics Committee 1 (certificate number M12/01/002), the Medical Research Council of Zimbabwe (certificate number MRCZ/A/1599), and the Argentinean National Ethical Committee, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), (Protocol Number: 725). In addition, the trial protocol was approved by the Research Project Review Panel of the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development, and Research Training in Human Reproduction at the Department of Reproductive Health and Research of WHO and the WHO Research Ethics Review Committee, Geneva, Switzerland (certificate number A65750). All participants enrolled in the trial provided written informed consent.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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