Clinical Trials Logo
  1. Home
  2. Preeclampsia
  3. NCT02238704

Cornell University-Micronutrient Initiative Calcium Supplementation Study — MICA  

Preeclampsia Clinical Trial

Official title:
A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations

Clinical Trial Summary

The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.

Clinical Trial Description

This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02238704
Study type Interventional
Source Cornell University
Contact
Status Completed
Phase N/A
Start date September 2014
Completion date June 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT03510286 - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting NCT04990141 - Molecular Screening Method for Preeclampsia (PREMOM)
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT05999851 - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy N/A
Recruiting NCT02923206 - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis N/A
Completed NCT02854501 - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Not yet recruiting NCT02541110 - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler N/A
Terminated NCT02558023 - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine Phase 3
Withdrawn NCT05016440 - Lisinopril for Renal Protection in Postpartum Preeclamptic Women N/A
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed NCT02554604 - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Recruiting NCT02247297 - Pancreatic Stone Protein (PSP) in Pregnant Women
Recruiting NCT02337049 - Preeclampsia Subtypes and Surrogate Markers of CVD Risk N/A
Completed NCT01195441 - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound N/A
Withdrawn NCT01179542 - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR N/A
Completed NCT00456118 - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting NCT00117546 - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A
Completed NCT04658966 - Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.