Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial (4P)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02007837|
Recruitment Status : Unknown
Verified November 2016 by Joyce L. Browne, UMC Utrecht.
Recruitment status was: Not yet recruiting
First Posted : December 11, 2013
Last Update Posted : November 25, 2016
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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
- 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
- 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.
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
|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|
|La General Hospital||Not yet recruiting|
|Contact: Patrick Frimpong, MBChB +233244270320 email@example.com|
|Principal Investigator: Patrick Frimpong, MBChB|
|Ridge Regional Hospital||Not yet recruiting|
|Contact: Emmanuel K Srofenyoh, MBChB +233208118509 firstname.lastname@example.org|
|Principal Investigator: Emmanuel K Srofenyoh, MBChB|
|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|