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

UMC Utrecht

Status and phase: Unknown; Phase 3

Conditions: Pregnancy Induced Hypertension

Treatments: Drug: Combined aspirin and multinutrient supplement; Other: Daily text reminder text messages

Study type: Interventional

Funder types: Other

Identifiers

NCT02007837

GHS-ERC: 05/05/2012

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups, including a placebo group

Combined aspirin and multinutrient supplement

Experimental group

Description:

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

Treatment:

Drug: Combined aspirin and multinutrient supplement

Other: Daily text reminder text messages

Placebo

Placebo Comparator group

Description:

5mg folic acid, cellulose filler

Treatment:

Other: Daily text reminder text messages