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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04051567
Other study ID # M2017047
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2018
Est. completion date December 1, 2020

Study information

Verified date October 2019
Source Ministry of Science and Technology of the People´s Republic of China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Twin pregnancies are associated with increased risk of perinatal adverse outcomes , including preeclampsia , fetal growth restriction , preterm premature rupture of membranes and preterm birth. Low-dose aspirin was recommend by American College of Obstetricians and Gynecologists (ACOG) during pregnancy. In this trial, the investigators suppose that aspirin used in twin-pregnancies could improve adverse pregnancy outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 425
Est. completion date December 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Twin pregnancy diagnosed by ultrasound and maternal age ranged from 18 to 55 years, Gestational age was less than 16w

Exclusion Criteria:

- Diagnosed fetal anomalies, history of cervical cerclage, contraindications of aspirin, pre-existing renal or liver diseases or abnormal functions, coagulation disorders, history of PE, preterm birth or FGR, chronic hypertension

Study Design


Intervention

Drug:
Aspirin 100mg
In LDA group, patients were asked for taking 100mg aspirin per night;

Locations

Country Name City State
China Hongbo,Qi Chongqing Chongqing

Sponsors (3)

Lead Sponsor Collaborator
Ministry of Science and Technology of the People´s Republic of China Chongqing Health Center for Women and Children, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of preeclampsia, preterm birth, fetal growth restriction after 30 weeks of gestional age
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