What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol

Giridhara R Babu, Maithili Karthik, Deepa Ravi, Yamuna Ana, Prafulla Shriyan, Kiran Kumar Hasige, Keerti Deshpande, Lokesh Bangalore Siddlingaiah, Sanjay Kinra, Gudlavalleti Venkata Satyanarayana Murthy, Giridhara R Babu, Maithili Karthik, Deepa Ravi, Yamuna Ana, Prafulla Shriyan, Kiran Kumar Hasige, Keerti Deshpande, Lokesh Bangalore Siddlingaiah, Sanjay Kinra, Gudlavalleti Venkata Satyanarayana Murthy

Abstract

Background: Cohort studies have public health importance as they effectively provide evidence on determinants of health from a life course perspective. Researchers often confront the poor follow-up rates as a major challenge in the successful conduct of cohort studies. We are currently recruiting in a birth cohort study, titled as "Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin" (MAASTHI) in a public hospital; with the aim of assessing maternal glycemic levels on the risk of adverse fetal outcomes. Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital.

Methods: A randomized trial of 795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14 weeks old. The comparator group receives a standard leaflet, with details on the importance of glucose testing and regular follow up in pregnancy. Intervention arm-1 will receive the standard leaflet plus individualized messages, through an Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system to remind the participants about the lab test and follow-up dates. Intervention arm- 2 will have the opportunity to attend Mother and Baby Affairs (MBA) workshops, which will provide information on Gestational Diabetes Mellitus (GDM) screening and management to pregnant women and personalized counselling services. The outcome of interest is the difference in the proportion of participants completing follow-up at different points in time, among three arms.

Discussion: Between the two interventions (IVR and MBA), the study results would uncover the contextually specific, timely intervention, which can increase the proportion of pregnant women followed up in public hospitals. If effective, this study will provide information on an effective intervention, useful in ensuring the success of longitudinal follow-up in the public hospitals.

Trial registration: NCT03088501 , Date Registered: 16/03/2017.

Keywords: Birth cohort; Care management; Cost-effective; Follow up; Health communication; Interactive voice response system; New technologies; Public hospital.

Conflict of interest statement

Ethics approval and consent to participate

We have obtained the ethical approval for the initial first wave of the cohort. The protocol for the proposed study was be reviewed and approved by the institutional ethical review board (IEC) at Bengaluru campus of Indian Institute of Public Health-Hyderabad, Bangalore. (Reference No IIPHHB/TRCIEC/117/2016). All the selected participants will be explained regarding the importance of participating in the trial and will be required to provide 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.

Figures

Fig. 1
Fig. 1
Flowchart depicting the study design and allocation of participants to different study arms

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