Aspirin in the Treatment of Pregnant Women With Adenomyosis on Reducing Preterm Delivery
Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
Objective: This study intends to carry out a randomized double-blind clinical trial study of
aspirin in the treatment of pregnancy with adenomyosis to reduce the incidence of preterm
delivery, and provide a new therapeutic target for the prevention and treatment of premature
birth and adverse pregnancy outcomes, and fill in the blank of effective prevention of
premature delivery in pregnancy with adenomyosis at home and abroad Application value and
social and economic benefits of the bed.
Methods: a randomized double-blind clinical trial was used in this study. In Shanghai first
maternal and child health care hospital, the pregnant women who meet the requirements of the
group will be given full informed consent. By using a random, double-blind research method,
1-550 digital computers are randomly divided into two groups, with two groups of digital
coding placebo and aspirin. From 12 weeks of gestation, 100 mg of placebo or low-dose aspirin
was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of
gestation.
Observe the outcome ① Main outcome measures: preterm delivery: delivery less than 37 weeks
gestational weeks, premature delivery. The specific classification includes: A. extremely
premature delivery, gestational age 28-32 weeks; B. early preterm birth, delivery gestational
weeks 32-34 gestational weeks; C. late preterm birth, 34-36 gestational weeks.
② Secondary outcome measures: abortion, gestational diabetes mellitus, gestational
hypertension, placental disorders, SGA / FGR, premature rupture of membranes, postpartum
hemorrhage, mode of delivery, etc.
The follow-up contents were as follows
- Routine prenatal examination, blood pressure, fetal size, vaginal bleeding, etc.
- Coagulation factor index: prothrombin time Pt, activated partial thrombin time
APTT, thrombin time TT, fibrinogen FIB, D-dimer
- Immune related indexes: antiphospholipid antibody, CA125 ④ Inflammatory index:
routine blood test + CRP
- Detection of cervical length by B-ultrasound ⑥ Pregnancy complications:
gestational diabetes mellitus, gestational hypertension and placental
disorders ⑦ Birth outcome: gestational weeks, birth weight, FGR,
premature delivery, mode of delivery, NICU rate, etc.