4P: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT02007837

Collaborator

Ghana Health Services (Other), University of Ghana (Other)

440

Enrollment

Locations

Arms

Duration (Months)

220

Patients Per Site

31.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Induced Hypertension	Drug: Combined aspirin and multinutrient supplement Other: Daily text reminder text messages	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Combined aspirin and multinutrient supplement Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed. Other: Daily text reminder text messages
Placebo Comparator: Placebo 5mg folic acid, cellulose filler	Other: Daily text reminder text messages

Arm

Intervention/Treatment

Experimental: 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

Drug: Combined aspirin and multinutrient supplement

Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.

Other: Daily text reminder text messages

Placebo Comparator: Placebo

5mg folic acid, cellulose filler

Other: Daily text reminder text messages

Outcome Measures

Primary Outcome Measures

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

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
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
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.