Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Combined aspirin and multinutrient supplement
- Conditions
- Pregnancy Induced Hypertension
- Sponsor
- UMC Utrecht
- Enrollment
- 440
- Locations
- 2
- Primary Endpoint
- Development of pregnancy-induced hypertension (PIH) in pregnancy
- Last Updated
- 9 years ago
Overview
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.
Investigators
Joyce L. Browne
MD, MSc,PhD candidate
UMC Utrecht
Eligibility Criteria
Inclusion Criteria
- •\<16 weeks of gestation and over 18 years of age,
- •Intention to have subsequent antenatal visits and delivery at the same clinic.
- •Can receive text messages by phone or through the phone of a proxy.
- •A moderate to high risk (\>20%) of developing PIH
Exclusion Criteria
- •Pre-existing hypertension or hypertension before 20 weeks gestation.
- •Likely non-compliance with the protocol in view of the treating physician
- •Comorbidity interfering with the protocol
- •Known contraindications to Investigational Product components
Arms & Interventions
Combined aspirin and multinutrient supplement
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
Intervention: Combined aspirin and multinutrient supplement
Combined aspirin and multinutrient supplement
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
Intervention: Daily text reminder text messages
Placebo
5mg folic acid, cellulose filler
Intervention: Daily text reminder text messages
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maternal/obstetric outcomes(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(1 year)
- Neonatal and infant outcomes(6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after)