Aspirin in the Treatment of Pregnant Women With Adenomyosis on Reducing Preterm Delivery
Clinical Randomized Controlled Trial of Aspirin in the Treatment of Pregnant Women With Adenomyosis on Reducing Preterm Delivery
1 other identifier
interventional
550
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 2, 2020
August 1, 2020
1.9 years
August 27, 2020
August 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Gestation 12-36 weeks
Secondary Outcomes (1)
Other complications
Gestation 12-36 weeks
Study Arms (2)
Aspirin group
ACTIVE COMPARATOR100 mg of low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
placebo group
PLACEBO COMPARATOR100 mg of placebo was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
qiaoling Du, doctorate
Shanghai first maternal and infant hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2020
First Posted
September 2, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
September 2, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share