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

Pregnancy Induced Hypertension Clinical Trial

— 4P  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02007837
• Other study ID #: GHS-ERC: 05/05/2012
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 26, 2013
• Last updated: November 23, 2016
• Start date: January 2018
• Est. completion date: August 2018

Study information

• Verified date: November 2016
• Source: UMC Utrecht
• Contact: Joyce L Browne, MD, MSc
• Phone: +31649650071
• Email: J.L.Browne[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Ghana: Food and Drug Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy Induced Hypertension

Intervention

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

Locations

Country	Name	City	State
Ghana	La General Hospital	Accra
Ghana	Ridge Regional Hospital	Accra

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Ghana Health Services, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 days after delivery.	No
Secondary	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	6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after	No
Secondary	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	6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after	No
Secondary	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.	1 year	No