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

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ClinicalTrials.gov Identifier: NCT02007837
Recruitment Status : Not yet recruiting
First Posted : December 11, 2013
Last Update Posted : November 25, 2016
Sponsor:
Collaborators:
Ghana Health Services
University of Ghana
Information provided by (Responsible Party):
Joyce L. Browne, 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Development of pregnancy-induced hypertension (PIH) in pregnancy [ Time Frame: 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 :
  1. Maternal/obstetric outcomes [ Time Frame: 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

  2. Neonatal and infant outcomes [ Time Frame: 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

  3. Number of participants with (severe) adverse events as a measure of safety and tolerability [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
La General Hospital Not yet recruiting
Accra, Ghana
Contact: Patrick Frimpong, MBChB    +233244270320    patrickfrimpong@hotmail.com   
Principal Investigator: Patrick Frimpong, MBChB         
Ridge Regional Hospital Not yet recruiting
Accra, Ghana
Contact: Emmanuel K Srofenyoh, MBChB    +233208118509    emmanuelsrofenyoh@gmail.com   
Principal Investigator: Emmanuel K Srofenyoh, 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

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
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Joyce L. Browne, UMC Utrecht:
pregnancy induced hypertension
gestational hypertension
pre-eclampsia
preeclampsia
hypertensive disorders in pregnancy

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Folic Acid
Vitamin B Complex
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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hematinics
Vitamins
Micronutrients
Growth Substances