Calcium supplementation to prevent pre-eclampsia: Protocol for an individual participant data meta-analysis, network meta-analysis and health economic evaluation

• Autores: Rocha, Thaís; Allotey, John; Palacios, Alfredo Daniel; Vogel, Joshua Peter; Smits, Luc; Carroli, Guillermo; Mistry, Hema; Young, Taryn; Qureshi, Zahida P.; Cormick, Gabriela; Snell, Kym I. E.; Abalos, Edgardo Javier; Pena Rosas, Juan Pablo; Khan, Khalid Saeed; Larbi, Koiwah Koi; Thorson, Anna; Singata Madliki, Mandisa; Hofmeyr, George Justus; Bohren, Meghan; Riley, Richard; Betran, Ana Pilar; Thangaratinam, Shakila
• Año de publicación: 2023
• Idioma: inglés
• Tipo de recurso: artículo
• Materia: HEALTH ECONOMICS; MATERNAL MEDICINE; PUBLIC HEALTH
• Institución: Consejo Nacional de Investigaciones Científicas y Técnicas

Introduction Low dietary calcium intake is a risk factor for pre-eclampsia, a major contributor to maternal and perinatal mortality and morbidity worldwide. Calcium supplementation can prevent pre-eclampsia in women with low dietary calcium. However, the optimal dose and timing of calcium supplementation are not known. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to determine the effects of various calcium supplementation regimens in preventing pre-eclampsia and its complications and rank these by effectiveness. We also aim to evaluate the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. Methods and analysis We will identify randomised trials on calcium supplementation before and during pregnancy by searching major electronic databases including Embase, CINAHL, MEDLINE, CENTRAL, PubMed, Scopus, AMED, LILACS, POPLINE, AIM, IMSEAR, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform, without language restrictions, from inception to February 2022. Primary researchers of the identified trials will be invited to join the International Calcium in Pregnancy Collaborative Network and share their IPD. We will check each study's IPD for consistency with the original authors before standardising and harmonising the data. We will perform a series of one-stage and two-stage IPD random-effect meta-analyses to obtain the summary intervention effects on pre-eclampsia with 95% CIs and summary treatment-covariate interactions (maternal risk status, dietary intake, timing of intervention, daily dose of calcium prescribed and total intake of calcium). Heterogeneity will be summarised using tau 2, I 2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Minor study effects (potential publication bias) will be investigated using funnel plots. A decision analytical model for use in low-income and middle-income countries will assess the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. Ethics and dissemination No ethical approvals are required. We will store the data in a secure repository in an anonymised format. The results will be published in peer-reviewed journals. PROSPERO registration number CRD42021231276.
Fil: Rocha, Thaís. The University Of Birmingham (tub);
Fil: Allotey, John. The University Of Birmingham (tub);
Fil: Palacios, Alfredo Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Vogel, Joshua Peter. World Health Organization; Suiza
Fil: Smits, Luc. Universiteit Maastricht.; Países Bajos
Fil: Carroli, Guillermo. Centro Rosarino de Estudios Perinatales; Argentina
Fil: Mistry, Hema. University of Warwick; Reino Unido
Fil: Young, Taryn. Stellenbosch University; Sudáfrica. South African Medical Research Council; Sudáfrica
Fil: Qureshi, Zahida P.. University of Nairobi; Kenia
Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Snell, Kym I. E.. Keele University; Reino Unido
Fil: Abalos, Edgardo Javier. Centro Rosarino de Estudios Perinatales; Argentina
Fil: Pena Rosas, Juan Pablo. World Health Organization; Suiza
Fil: Khan, Khalid Saeed. Universidad de Granada; España
Fil: Larbi, Koiwah Koi. Action on Preeclampsia; Ghana
Fil: Thorson, Anna. World Health Organization; Suiza
Fil: Singata Madliki, Mandisa. East London Hospital Complex; Sudáfrica
Fil: Hofmeyr, George Justus. Frere Hospital; Sudáfrica
Fil: Bohren, Meghan. University of Melbourne; Australia
Fil: Riley, Richard. Keele University; Reino Unido
Fil: Betran, Ana Pilar. World Health Organization; Suiza
Fil: Thangaratinam, Shakila. Birmingham Women’s and Children’s Hospitals NHS Foundation Trust; Reino Unido. University Of Birmingham;