Clinical Trial: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial

Brief Summary: Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.

Detailed Summary:
Sponsor: UMC Utrecht

Current Primary Outcome: Development of pregnancy-induced hypertension (PIH) in pregnancy [ Time Frame: up to 2 days after delivery. ]

Development of a de novo systolic blood pressure (SBP) of > 140 mmHg, diastolic blood pressure (DBP) of >90 mmHg, measured at least twice.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maternal/obstetric outcomes [ Time Frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after ]
    maternal death, preeclampsia, eclampsia, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, hemorrhage, caesarian section, other complications during pregnancy or delivery
  • Neonatal and infant outcomes [ Time Frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after ]
    preterm birth, Intra uterine death, stillbirth, neonatal mortality, congenital abnormality, Neonatal Intensive Care Unit (NICU) admission or pediatrician referral, birth weight, small for gestational age, apgar scores, other adverse effects. Infant outcomes: weight and height, health, occurrence of disease and general health status
  • Number of participants with (severe) adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]

    Number of patients with (severe) adverse events. Adverse events include any undesirable experience associated with the use of a medical product. Related to the product, bleeding incidences (including bruises), nausea, vomiting, will be explicitly reported.

    Severe adverse events are: death, life-threatening conditions, (prolonged) hospitalization, disability and permanent damage to mother or fetus, congenital abnormality, or other important (serious) medical events.



Original Secondary Outcome: Same as current

Information By: UMC Utrecht

Dates:
Date Received: November 26, 2013
Date Started: January 2018
Date Completion: August 2018
Last Updated: November 23, 2016
Last Verified: November 2016