Pregnancy Induced HypertensionPhase 34PNCT02007837
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
A Phase 3 study testing Combined aspirin and multinutrient supplement and Daily text reminder text messages in people with Pregnancy Induced Hypertension, run by UMC Utrecht at 2 sites in Ghana.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Induced Hypertension
- What is being tested?
- Combined aspirin and multinutrient supplement and Daily text reminder text messages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 2 sitesGhana
- Study dates
- Jan 2018to Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- <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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Ghana2 sites
La General Hospital
Accra
Patrick Frimpong, MBChB, +233244270320, patrickfrimpong@hotmail.com
Patrick Frimpong, MBChB
Ridge Regional Hospital
Accra
Emmanuel K Srofenyoh, MBChB, +233208118509, emmanuelsrofenyoh@gmail.com
Emmanuel K Srofenyoh, MBChB
About this study
Official title: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
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.
- Conditions
- Pregnancy Induced Hypertension
- Being tested
- Combined aspirin and multinutrient supplement, Daily text reminder text messages
- Keywords
- pregnancy induced hypertension, gestational hypertension, pre-eclampsia, preeclampsia, hypertensive disorders in pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined aspirin and multinutrient supplementDrug
Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.
Daily text reminder text messagesOther
| Study group | Role | What they receive |
|---|---|---|
| Combined aspirin and multinutrient supplement | Experimental | 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 Receives: Drug: Combined aspirin and multinutrient supplement; Other: Daily text reminder text messages |
| Placebo | Placebo comparator | 5mg folic acid, cellulose filler Receives: Other: Daily text reminder text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 days after delivery.
Secondary outcomes (3)
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
Measured: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
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
Measured: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2018
- Primary completionApr 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Induced HypertensionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Services, University of Ghana
- Responsible party
- Principal investigator, Joyce L. Browne, UMC Utrecht
- Investigators
- Diederick E Grobbee, MD PhD, Principal investigator, UMC UtrechtPatrick Frimpong, MBbCh, Principal investigator, Ghana Health ServicesEmmanuel K Srofenyoh, MBbCb, Principal investigator, Ghana Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007837
- Sponsor's protocol ID
- GHS-ERC: 05/05/2012
- Acronym
- 4P
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2013
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02007837
- Acronym / sponsor ID
- 4P / GHS-ERC: 05/05/2012
- Conditions
- Pregnancy Induced Hypertension
- Keywords
- pregnancy induced hypertension, gestational hypertension, pre-eclampsia, preeclampsia, hypertensive disorders in pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Ghana Health Services, University of Ghana
- Study start
- Jan 2018
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined aspirin and multinutrient supplement | Experimental | Drug: Combined aspirin and multinutrient supplement, Other: Daily text reminder text messagesIn 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 |
| Placebo | Placebo comparator | Other: Daily text reminder text messages5mg folic acid, cellulose filler |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- <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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined aspirin and multinutrient supplementSingle capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed. | Drug | Combined aspirin and multinutrient supplement |
| Daily text reminder text messages | Other | Combined aspirin and multinutrient supplement, Placebo |
Primary outcome
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.
3 secondary outcomes
Maternal/obstetric outcomes
Time frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Neonatal and infant outcomes
Time frame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Number of participants with (severe) adverse events as a measure of safety and tolerability
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederick E Grobbee, MD PhD principal investigator
UMC Utrecht
Patrick Frimpong, MBbCh principal investigator
Ghana Health Services
Emmanuel K Srofenyoh, MBbCb principal investigator
Ghana Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined aspirin and multinutrient supplement and Daily text reminder text messages in people with Pregnancy Induced Hypertension, run by UMC Utrecht at 2 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joyce L Browne, MD, MSc (+31649650071, J.L.Browne@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of pregnancy-induced hypertension (PIH) in pregnancy (time frame: up to 2 days after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.