High Risk Pregnancy for preeclampsia. Supervision of high-risk pregnancy
Conditions
Interventions
Intervention 1: Intervention group: pregnant mothers are at high risk for preeclampsia, who take a low-dose aspirin 80 or 100 mg daily at night, at bedtime, from the beginning of the first trimester.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The participants are pregnant women at high-risk for preeclampsia based on demographic characteristics and personal and obstetrics history, according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to nonsteroidal anti-inflammatory drug products 2) Asthma-rhinitis and nasal polyps 3) Sever renal or sever hepatic impairment. 4) History of gastrointestinal bleeding or active peptic ulcer disease 5) vaginal bleeding or significant hematoma on ultrasound. 6)gestational age > 16 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-eclampsia: Hypertension with proteinuria occurs for the first time after the 20th week of pregnancy. According to the definition of systolic blood pressure >= 140 mm Hg and diastolic blood pressure >= 90 mm Hg recorded at least during two measurements with an interval of 4 hours, along with one or more of the following that occurred for the first time after 20 weeks. given. Timepoint: The visit intervals of the participants are montly, up to 28 weeks, every two weeks up to 32 weeks, and weekly up to 36 weeks. Method of measurement: 1- Proteinuria: Excretion >=30 mg/mol in the protein/creatinine ratio; or >=300 mg in 24-hour urine; or >=2+ in urine dipstic test.2- Evidence of dysfunction of the organs of the mother's body: including acute kidney damage (creatinine >=1 mg/dL); Liver involvement (increase of transaminases including alanine aminotransferase or aspartate aminotransferase >=40 iu/l); with or without pain in the epigastric region, neurological complications (eclampsia-altered state of consciousness-blurred vision-clonus-severe headache-persistent visual scotoma); or hematological changes (thrombocytopenia-diffuse intravascular coagulopathy-hemolysis).3- Utero-placental dysfunction: such as intrauterine growth restriction, abnormal Doppler of the umbilical artery or fetal death). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks. Timepoint: by performing serial biometrics during pregnancy. Method of measurement: ulrasound.;Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at=20 weeks. Timepoint: by performing serial ultrasound during pregnancy. Method of measurement: ultrasound.;Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks. Timepoint: routine visits. Method of measurement: history and examination.;Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity. Timepoint: after the birth. Method of measurement: examination.;Admission to Neonate Intensive Care Unit. Timepoint: After the birth. Method of measurement: examination of newborn.;Incidence of placental abruption (clinically or on placental examination). Timepoint: at the delivery. Method of measurement: clinical examination.;Ventilation requirement is defined as the need for positive pressure. Timepoint: after the birth. Method of measurement: clinical examination.;Neonatal anomaly especially gastroschisis. Timepoint: During the fetal period and at the time of birth. Method of measurement: with ultrasound during pregnancy and postnatal examinations. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArezoo Behzadian
Tehran University of Medical Sciences
Outcome results
None listed