Clinical Trial: A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Clinical Trial of Oral Magnesium Supplementation In Pregnancy for the Prevention of Preterm Birth and Perinatal and Maternal Morbidity

Brief Summary: The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn, should reduce the need for indicated preterm delivery. This strategy is a multicenter, randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the intestinal tract. The results of this RCT may be especially relevant in low and middle income countries that have high rates of prematurity, and limited resources for acute newborn and maternal care.

Detailed Summary:

The investigators will complete a multicenter double-blind, placebo-controlled randomized clinical trial of oral Mg++citrate supplementation.

Setting: (1) Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife-Pernambuco: IMIP maintains the largest hospital in Brazil exclusively dedicated to Brazilian Health System, [Sistema Único de Saúde] (SUS). IMIP has 1,032 beds and performs more than 2,000 clinical daily visits. IMIP enrolls about 6,000 deliveries per year and has an obstetric intensive care unit. IMIP is a teaching hospital (degree programs in medicine, nursing, nutrition, physical therapy, pharmacology and psychology and postgraduate - residency, master and doctoral) and is a reference center to woman assistance in Northeast Brazil by the Ministry of Health of the Federal Government. (2) Dom Malan Hospital (HDM), Petrolina-Pernambuco: HDM assists the population of about 1 million people in 55 municipalities of Pernambuco, Bahia and Piauí States. HDM assists about 1,500 pregnant women monthly in emergency service and performs an average of 528 prenatal visits including high-risk pregnancy (±35%). HDM enrolls about 600 deliveries/month and also has an obstetric intensive care unit. HDM has a teaching program for medical and nursing students and also develops a residence program.

Data collection will be conducted from March 2014 to August 2015. Study population will be all pregnant women since they started their prenatal care visits at IMIP and/or HDM before 20th gestational week.

At a sample size of 1000 women assigned to placebo and 2000 women assigned to Mg++ citrate, with power of 80% and a 2-sided P-value of 0.05, we will be able to detect at least a 22% relative risk reduction in the primary perinatal composite outcome, assuming
Sponsor: Professor Fernando Figueira Integral Medicine Institute

Current Primary Outcome: Preterm birth [ Time Frame: Delivery ]

Delivery before 37 gestational week


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gestational diabetes mellitus [ Time Frame: 24th 28th gestational week ]
  • Pre-eclampsia [ Time Frame: 24th to 38th gestational week ]
  • Low birth weight [ Time Frame: Delivery ]


Original Secondary Outcome: Same as current

Information By: Professor Fernando Figueira Integral Medicine Institute

Dates:
Date Received: December 19, 2013
Date Started: March 2014
Date Completion: December 2015
Last Updated: March 10, 2015
Last Verified: March 2015