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

NCT ID: NCT04051567

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Twin Pregnancy Preeclampsia Preterm Birth Fetal Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LDA group

Group Type EXPERIMENTAL

Aspirin 100mg

Intervention Type DRUG

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

NC group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin 100mg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role collaborator

Ministry of Science and Technology of the People“s Republic of China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hongbo Qi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hongbo,Qi

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Hongbo Qi, Prof.

Role: primary

+86-023-89011101

Other Identifiers

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M2017047

Identifier Type: -

Identifier Source: org_study_id

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