Preterm Birth Clinical Trial
Official title:
A Randomized Clinical Trial of Oral Magnesium Supplementation In Pregnancy for the Prevention of Preterm Birth and Perinatal and Maternal Morbidity
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.
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 a primary
perinatal composite outcome rate of 18% in the placebo group and 14% in the Mg++ group. In
Recife there are 25,000 births a year. Of these 25,000, at least 30% (7,500) would attend one
of the study prenatal clinics, & of those 7,500, 60% (4,500) would meet ≥1 of the eligibility
criteria. With a participation rate of 50%, 2,250 women can be recruited in a year, thus
requiring 1.25 years to recruit all women, and 2 years ascertain all primary outcome events.
A systematic sample will be obtained from low risk pregnant women who begin prenatal care
visits before 20th gestational week at IMIP or HDM, during the study period.
Pregnant women admitted to the study will continue with their normal attendance at IMIP or
HDM. There will be no interference by the researchers in obstetric management of patients
involved in the study. All pregnant women will be followed until the postpartum and the
newborn until hospital discharge.Hematologic and urine tests will be performed every month
(four times) to evaluate Mg++ concentration from each pregnant woman. After inclusion in the
study, pregnant women will be monitored monthly until delivery. Pregnant women who do not
attend the clinic visit schedule, will be contacted by phone and/or visited. Losses after
randomization will be registered with the respective reason.
Randomization will be performed by the "Random Allocation" software, version 1.0. After
signing the consent form each participant will be allocated to the "magnesium" or "placebo"
group.
Oral Mg++citrate, 150 mg twice daily. Each capsule will contained 150 mg of elemental
magnesium citrate. The participants will be instructed to take one capsule twice daily until
delivery.
Compliance/adherence, adverse events, and clinical intercurrence will be monitored by the
research team at each routine prenatal visit until the completion of the treatment. Adherence
will be defined as the ingestion of at least 80% of the prescribed dose.
Quality Control of Information: The forms will be completed by the researcher and stored in a
specific folder. All data collection will be checked by a monitor.
Analysis: Primary and secondary endpoints will be compared between groups. Continuous data
will be tested using the unpaired two-tailed t-test (if normally distributed) and the
Mann-Whitney U-test (if non-normally distributed). Fisher's exact test will be used for
nominal data. A significance value <0.05 will be used in all tests.
Ethical aspects: This project will be submitted to IMIP's and Dom Malan Hospital Committee on
Ethical Research. Each participating woman in the study will sign an informed consent. They
will be free to withdraw from the trial at any time. The trial will be conducted according to
the WHO guidelines for good clinical trial practice.
To ensure the safety of participants and the validity and integrity of the data a Data and
Safety Monitoring Board (DSMB) will be created to follow the study. The DSMB will consist of
5 experts members representing the following institutions and not involved with this trial:
Bill and Melinda Gates Foundation, Ministry of Health of Brazilian Government, IMIP, Dom
Malan Hospital and an statistician. The DSMB will periodically review the accumulated study
data for pregnant women and fetus safety, study conduct, progress and efficacy. DSMB also can
make recommendations to continuation, modification or termination of this trial.
Conflict of interest: Nothing to declare. This project will be entered in the international
registry of clinical trials.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04811742 -
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
|
N/A |