NCT04051567

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
425

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

July 9, 2019

Last Update Submit

October 25, 2019

Conditions

Twin PregnancyPreeclampsiaPreterm BirthFetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • The incidence of preeclampsia, preterm birth, fetal growth restriction

    after 30 weeks of gestional age

Study Arms (2)

LDA group

EXPERIMENTAL
Drug: Aspirin 100mg

NC group

NO INTERVENTION

Interventions

Aspirin 100mgDRUG

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

LDA group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongbo,Qi

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaPremature BirthFetal Growth Retardation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2019

First Posted

August 9, 2019

Study Start

November 1, 2018

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

CN(1)