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: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai First Maternity and Infant Hospital
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• ① Singleton; ② in line with the diagnosis of adenomyosis in pregnancy; ③ no history of chronic diseases and definite diagnosis of endocrine diseases, including diabetes, hypertension, obesity, antiphospholipid syndrome; ④ informed consent and voluntary participation in this study.

Exclusion Criteria:

• ① twins / multiple births; ② induced labor for medical reasons; ③ allergic to aspirin or other salicylates, tetracycline drugs or any other components of drugs; ④ patients with mental disorders; ⑤ transferred to hospital.