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

Sponsor

Ministry of Science and Technology of the People´s Republic of China (Other)

Overall Status

Unknown status

CT.gov ID

NCT04051567

Collaborator

Peking University Third Hospital (Other), Chongqing Health Center for Women and Children (Other)

425

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy Preeclampsia Preterm Birth Fetal Growth Restriction	Drug: Aspirin 100mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

425 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LDA group	Drug: Aspirin 100mg In LDA group, patients were asked for taking 100mg aspirin per night;
No Intervention: NC group

Arm

Intervention/Treatment

Experimental: LDA group

Drug: Aspirin 100mg

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

No Intervention: NC group

Outcome Measures

Primary Outcome Measures

The incidence of preeclampsia, preterm birth, fetal growth restriction [after 30 weeks of gestional age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hongbo,Qi	Chongqing	Chongqing	China	400000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongbo Qi, Professor, Ministry of Science and Technology of the People´s Republic of China

ClinicalTrials.gov Identifier:

NCT04051567

Other Study ID Numbers:

M2017047

First Posted:

Aug 9, 2019

Last Update Posted:

Oct 29, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pre-Eclampsia

Premature Birth

Fetal Growth Retardation

Aspirin

Study Results

No Results Posted as of Oct 29, 2019