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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by UMC Utrecht
Sponsor:
Collaborators:
Ghana Health Services
University of Ghana
Information provided by (Responsible Party):
Joyce L. Browne, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02007837
First received: November 26, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Pregnancy Induced Hypertension
Drug: Combined aspirin and multinutrient supplement
Other: Daily text reminder text messages
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Development of pregnancy-induced hypertension (PIH) in pregnancy [ Time Frame: up to 2 days after delivery. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 440
Study Start Date: October 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007837

Contacts
Contact: Joyce L Browne, MD, MSc +31649650071 J.L.Browne@umcutrecht.nl
Contact: Diederick E Grobbee, MD, PhD +31 (0)88 755 9358 D.E.Grobbee@umcutrecht.nl

Locations
Ghana
Ridge Regional Hospital Not yet recruiting
Accra, Ghana
Contact: Emmanuel K Srofenyoh, MBChB    +233208118509    emmanuelsrofenyoh@gmail.com   
Principal Investigator: Emmanuel K Srofenyoh, MBChB         
La General Hospital Not yet recruiting
Accra, Ghana
Contact: Patrick Frimpong, MBChB    +233244270320    patrickfrimpong@hotmail.com   
Principal Investigator: Patrick Frimpong, MBChB         
Sponsors and Collaborators
UMC Utrecht
Ghana Health Services
University of Ghana
Investigators
Principal Investigator: Diederick E Grobbee, MD PhD UMC Utrecht
Principal Investigator: Patrick Frimpong, MBbCh Ghana Health Services
Principal Investigator: Emmanuel K Srofenyoh, MBbCb Ghana Health Services
  More Information

No publications provided

Responsible Party: Joyce L. Browne, MD, MSc,PhD candidate, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02007837     History of Changes
Other Study ID Numbers: GHS-ERC: 05/05/2012
Study First Received: November 26, 2013
Last Updated: August 11, 2014
Health Authority: Ghana: Food and Drug Authority

Keywords provided by UMC Utrecht:
pregnancy induced hypertension
gestational hypertension
pre-eclampsia
preeclampsia
hypertensive disorders in pregnancy

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014