Pre-Eclampsia
Conditions
Keywords
Pre-Eclampsia, Aspirin
Brief summary
This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.
Interventions
OTHERLow-dose aspirin in women with high risk of preeclampsia
Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight \<40 Kg, from \<15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor
Sponsors
Chiu Yee Liona Poon
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a stepped wedge cluster-randomized trial. There are total of 7 clusters across Asia. This study involves a period where no intervention will take place at all recruiting units, i.e. routine prenatal care, and then at regular intervals (every 6 weekly), one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis for high-risk women.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy; * Live fetus;
Exclusion criteria
* Multiple pregnancy; * Major fetal defects identified at 11-13 weeks of assessment; * Non-viable fetus (missed spontaneous abortion or stillbirth).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery with preterm-preeclampsia | Before 37 weeks of gestation | Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal mortality | during the first 28 days of life (0-27 days) | A neonatal death is a death during 0-27 days of life. Composite neonatal morbidity (any one of the following): \> grade II intraventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention. Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation. |
| Low birth weight | at birth | Low birth weight \<3rd, 5th and 10th percentile |
| Stillbirth | at or after 20 to 28 weeks of pregnancy | Fetal death at or after 20 to 28 weeks of pregnancy |
| Spontaneous preterm birth | At <34 and <37 weeks' gestation | Spontaneous preterm birth (SPB) includes preterm labor, preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM) and cervical weakness; it does not include indicated preterm delivery for maternal or fetal conditions. |
| Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation | at <34, <37 and ≥37 weeks of gestation | including preeclampsia, gestational hypertension, small for gestational age birth weight (\<5th percentile), stillbirth, placental abruption |
| Acceptability for aspirin treatment. | from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor | When patients are subjected to be high risks in preeclampsia screening, they will be asked if they accept the aspirin for treatment. If they do not accept, they will continue with routine care. The willingness of subjects will all be recorded on the Case report forms for data collection. |
| Composite neonatal morbidity | during the first 28 days of life (0-27 days) | Composite neonatal morbidity (any one of the following): \> grade II intraventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention. |
| Composite neonatal therapy | during the first 28 days of life (0-27 days) | Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation. |
| Gestational age at delivery | at delivery | Gestational age at delivery |
| Acceptability for PE screening | in the first trimester of pregnancy (11-13 weeks of gestation) | If subjects are under the intervention group upon proper consent procedure is done, at 11-13 weeks of gestation, the procedures below will be done. 1. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication) 2. Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols. 3. Blood sample will be drawn to determine of serum level of PIGF. The individual study participant's risk of preterm-PE will be computed using the Bayes based method. |
Countries
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
Outcome results
None listed