Preeclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Randomization will be done through a lottery with closed envelopes:
1. Aspirin group: take 75 mg of aspirin after lunch on a full stomach
2. Control group: do not take
Sponsors
Beacon Pharmaceuticals Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/05/2022: 1. Maternal age =18 years 2. Live foetus at gestational age 12–19 weeks 3. Any one of the following criteria: 3.1. BMI =30 kg/m2 3.2. Pregnancy interval >10 years 3.3. Multiple pregnancy 3.4. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization 3.5. Pregnant women with medical disorders, e.g. chronic hypertension, hyperglycaemia in pregnancy, autoimmune disease (e.g. antiphospholipid syndrome [APS], systemic lupus erythematosus [SLE]) 3.6. Previous history of gestational hypertension, pre-eclampsia or eclampsia 3.7. Previous history of intrauterine growth restriction (IUGR), intrauterine death or stillbirth 3.8. Family history (mother and/or sister) of hypertension, gestational hypertension or pre-eclampsia _____ Previous inclusion criteria: 1. Nulliparous 2. Maternal age =16 years and =35 years 3. BMI =30 kg/m² 4. Live foetus at gestational age 12 weeks – 19 weeks 5. Pregnancy interval >10 years 6. Multiple pregnancy 7. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization 8. Pregnant women with medical disorders: chronic HTN, hyperglycaemia in pregnancy, thyroid disorder, autoimmune disease - antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE) 9. Previous history of gestational HTN, preeclampsia (PE), eclampsia 10. Previous history of intrauterine growth restriction (IUGR), IUD, stillbirth 11. Family history of HTN, gestational HTN, PE (mother and/or sister)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 26/05/2022: 1. Allergic to aspirin 2. Peptic ulcer disease 3. Mental disease 4. Treatment with antifolate drugs (antiepileptics, methotrexate) 5. Patient will not give consent to participate _____ Previous exclusion criteria: 1. Allergic to aspirin 2. Peptic ulcer disease 3. Pregnant women who are at risk of developing PE but who have renal failure, hepatic failure, cardiac failure and hematological disorder 4. Mental disease 5. Treatment with antifolate drugs (antiepileptics, methotrexate) 6. Patient will not give consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of preeclampsia measured by measuring blood pressure (following standard procedures) and proteinuria (by dipstick test) at the time of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal: 1. Gestational hypertension (HTN) measured by measuring blood pressure (following standard procedures) at the time of delivery 2. Oligohydramnios measured using the amniotic fluid index (AFI) at the time of delivery. 3. Preterm labour measured by history taking and examination during each follow up (24, 32 and 36 weeks then weekly until delivery) 4. Antepartum haemorrhage (APH) measured by history taking and examination during each follow up (24, 32 and 36 weeks then weekly until delivery) Fetal: 1. Low birth weight by measuring the weight of baby after delivery 2. Preterm birth (defined as baby born before 37 weeks) 3. Small for gestational age measured by ultrasound color Doppler during follow up 4. Intrauterine death (IUD) after 28 weeks of gestation 5. Stillbirth (death during the process of delivery) 6. Neonatal intensive care unit (NICU) admission recorded after delivery | — |
Countries
Bangladesh
Contacts
Public ContactShapla Khatun
Outcome results
None listed