This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at \<37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.
All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,000
75 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral
up to 1.5 g metformin (C4H11N5, CAS number 657-24-9) daily, Oral Dose increases from 0.5g to 1.0g to 1.5g
150 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
WITHDRAWNThe Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Incidence of preterm preeclampsia(<37 weeks)
Preeclampsia will be defined as per the International Society for the Study of Hypertension in Pregnancy.The Proportions of delivery with preterm-preeclampsia between different intervention groups will be measured.
Time frame: ≥20 weeks to <37 weeks of gestation
Adverse outcome of pregnancy at <37 weeks.
including preeclampsia requiring delivery, gestational age (SGA; \<5th percentile) requiring delivery, miscarriage or still birth or placental abruption.
Time frame: <37 weeks of gestation
Adverse outcome of pregnancy at <34 weeks.
including preeclampsia requiring delivery, gestational age (SGA; \<5th percentile) requiring delivery, miscarriage or still birth or placental abruption.
Time frame: <34 weeks of gestation
Adverse outcome of pregnancy at ≥37 weeks
including preeclampsia requiring delivery, gestational age (SGA; \<5th percentile) requiring delivery, stillbirth or placental abruption.
Time frame: ≥37 weeks of gestation
Neonatal mortality
A neonatal death is a death during 0-27 days of life.
Time frame: During the first 28 days of life (0-27days)
Neonatal morbidity
Composite neonatal morbidity (any one of the following): \>grade II intra-ventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention.
Time frame: During the first 28 days of life (0-27days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pills with shape, color and smell same with acetylsalicylic acid and metformin, daily, oral
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGNeonatal birthweight below the 3rd,5th and 10th centile.
Birthweight and birthweight percentile for gestational age at delivery is calculated using a normal range derived in a Chinese population.
Time frame: At delivery
Stillbirth or neonatal death
Stillbirth: the death of a baby before or during birth after 24 weeks of gestation. Neonatal death: the death of a baby within the first 28 days of life.
Time frame: At delivery
<34 weeks and <37 weeks spontaneous preterm delivery
Spontaneous delivery at \<34 weeks(early preterm) and at \<37 weeks(total preterm) includes those with spontaneous onset of labor and those with preterm pre-labor rupture of membranes (PPROM).
Time frame: At spontaneous delivery
Gestational age
Gestation is the period of time between conception and birth. During this time, the baby grows and develops inside the mother's womb. Gestational age is the common term used during pregnancy to describe how far along the pregnancy is. It is measured in weeks, from the first day of the woman's last menstrual cycle to the current date. A normal pregnancy can range from 38 to 42 weeks.
Time frame: At delivery