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| Name | Class |
|---|---|
| Ghana Health Services | OTHER_GOV |
| University of Ghana | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | 5mg folic acid, cellulose filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined aspirin and multinutrient supplement | Drug | Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 days after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce L Browne, MD, MSc | Contact | +31649650071 | J.L.Browne@umcutrecht.nl | |
| Diederick E Grobbee, MD, PhD | Contact | +31 (0)88 755 9358 | D.E.Grobbee@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Diederick E Grobbee, MD PhD | UMC Utrecht | Principal Investigator |
| Patrick Frimpong, MBbCh | Ghana Health Services | Principal Investigator |
| Emmanuel K Srofenyoh, MBbCb |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La General Hospital | Accra | Ghana |
|
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| Daily text reminder text messages | Other |
|
| 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 |
| 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. | 1 year |
| Ghana Health Services |
| Principal Investigator |
| Ridge Regional Hospital | Accra | Ghana |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |