Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies

Preterm Birth Clinical Trial

Official title:

Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies--A Multicenter, Prospective, Open, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04051567
• Other study ID #: M2017047
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation
• Pre-Eclampsia
• Preeclampsia
• Premature Birth
• Preterm Birth
• Twin Pregnancy

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