A Phase 3 interventional study of Combined aspirin and multinutrient supplement and Daily text reminder text messages in Pregnancy Induced Hypertension, sponsored by UMC Utrecht. Status unknown at 2 sites in Ghana. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by UMC Utrecht · Phase 3, Interventional, and Prevention
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.
245 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 68 are open to participants now.
This study's planned enrollment of 440 is above the median of 142 across 166 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →UMC Utrecht is the lead sponsor of 363 studies on the registry; 81 are open to participants now.
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Exclusion Criteria:
In a single capsule, the following will be combined: 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12
Drug: Combined aspirin and multinutrient supplement · Other: Daily text reminder text messages
5mg folic acid, cellulose filler
Other: Daily text reminder text messages
Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.
Development of pregnancy-induced hypertension (PIH) in pregnancy
Development of a de novo systolic blood pressure (SBP) of \> 140 mmHg, diastolic blood pressure (DBP) of \>90 mmHg, measured at least twice.
Time frame: up to 2 days after delivery.
Maternal/obstetric outcomes
maternal death, preeclampsia, eclampsia, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, hemorrhage, caesarian section, other complications during pregnancy or delivery
Time frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Neonatal and infant outcomes
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
Time frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Number of participants with (severe) adverse events as a measure of safety and tolerability
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.
Time frame: 1 year
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hypertension, Pregnancy-Induced →