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

Phase 3

• Conditions: Pregnancy Induced Hypertension
• Interventions: Drug: Combined aspirin and multinutrient supplement; Other: Daily text reminder text messages

• Registration Number: NCT02007837
• Lead Sponsor: UMC Utrecht

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25
• Study Start: 2018-01
• Primary Completion: 2018-04
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
Combined aspirin and multinutrient supplement	Daily text reminder text messages	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
Placebo	Daily text reminder text messages	5mg folic acid, cellulose filler

Primary Outcome Measures

Name	Time	Method
Development of pregnancy-induced hypertension (PIH) in pregnancy	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 Outcome Measures

Name	Time	Method
Maternal/obstetric outcomes	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
Number of participants with (severe) adverse events as a measure of safety and tolerability	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.
Neonatal and infant outcomes	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

Trial Locations

Locations (2)

La General Hospital; 🇬🇭 Accra, Ghana

Ridge Regional Hospital; 🇬🇭 Accra, Ghana