Pregnancy Induced Hypertension
Conditions
Keywords
pregnancy induced hypertension, gestational hypertension, pre-eclampsia, preeclampsia, hypertensive disorders in pregnancy
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.
Interventions
DRUGCombined 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.
OTHERDaily text reminder text messages
Sponsors
Ghana Health Services
University of Ghana
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of pregnancy-induced hypertension (PIH) in pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| Maternal/obstetric outcomes | 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 | 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 | 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. |
Countries
Ghana
Contacts
Primary ContactJoyce L Browne, MD, MSc
Backup ContactDiederick E Grobbee, MD, PhD
Outcome results
None listed