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

Primary Purpose

Pregnancy Induced Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
Combined aspirin and multinutrient supplement
Daily text reminder text messages
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Induced Hypertension focused on measuring pregnancy induced hypertension, gestational hypertension, pre-eclampsia, preeclampsia, hypertensive disorders in pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • La General Hospital
  • Ridge Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combined aspirin and multinutrient supplement

Placebo

Arm 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

5mg folic acid, cellulose filler

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
November 26, 2013
Last Updated
November 23, 2016
Sponsor
UMC Utrecht
Collaborators
Ghana Health Services, University of Ghana
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1. Study Identification

Unique Protocol Identification Number
NCT02007837
Brief Title
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
Acronym
4P
Official Title
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Ghana Health Services, University of Ghana

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Induced Hypertension
Keywords
pregnancy induced hypertension, gestational hypertension, pre-eclampsia, preeclampsia, hypertensive disorders in pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined aspirin and multinutrient supplement
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5mg folic acid, cellulose filler
Intervention Type
Drug
Intervention Name(s)
Combined aspirin and multinutrient supplement
Intervention Description
Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.
Intervention Type
Other
Intervention Name(s)
Daily text reminder text messages
Primary Outcome Measure Information:
Title
Development of pregnancy-induced hypertension (PIH) in pregnancy
Description
Development of a de novo systolic blood pressure (SBP) of > 140 mmHg, diastolic blood pressure (DBP) of >90 mmHg, measured at least twice.
Time Frame
up to 2 days after delivery.
Secondary Outcome Measure Information:
Title
Maternal/obstetric outcomes
Description
maternal death, preeclampsia, eclampsia, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, hemorrhage, caesarian section, other complications during pregnancy or delivery
Time Frame
6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Title
Neonatal and infant outcomes
Description
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
Time Frame
6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Title
Number of participants with (severe) adverse events as a measure of safety and tolerability
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce L Browne, MD, MSc
Phone
+31649650071
Email
J.L.Browne@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Diederick E Grobbee, MD, PhD
Phone
+31 (0)88 755 9358
Email
D.E.Grobbee@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diederick E Grobbee, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Frimpong, MBbCh
Organizational Affiliation
Ghana Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel K Srofenyoh, MBbCb
Organizational Affiliation
Ghana Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
La General Hospital
City
Accra
Country
Ghana
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Frimpong, MBChB
Phone
+233244270320
Email
patrickfrimpong@hotmail.com
First Name & Middle Initial & Last Name & Degree
Patrick Frimpong, MBChB
Facility Name
Ridge Regional Hospital
City
Accra
Country
Ghana
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel K Srofenyoh, MBChB
Phone
+233208118509
Email
emmanuelsrofenyoh@gmail.com
First Name & Middle Initial & Last Name & Degree
Emmanuel K Srofenyoh, MBChB

12. IPD Sharing Statement

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