Low-dose Aspirin for Prevention of Adverse Pregnancy Outc... | NCT04051567

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

NCT04051567

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 29, 2019Actual

Enrollment

425Estimated

Phase

Phase 4

Conditions

Twin Pregnancy
Preeclampsia
Preterm Birth
Fetal Growth Restriction

Interventions

Aspirin 100mg

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Aug 8, 2019

First Posted Date

Aug 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Ministry of Science and Technology of the People´s Republic of ChinaOTHER_GOV

Collaborators

Name	Class
Peking University Third Hospital	OTHER
Chongqing Medical Center for Women and Children	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

425Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LDA group	Experimental		Drug: Aspirin 100mg
NC group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin 100mg	Drug	In LDA group, patients were asked for taking 100mg aspirin per night;	LDA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of preeclampsia, preterm birth, fetal growth restriction		after 30 weeks of gestional age

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hongbo,Qi	Recruiting	Chongqing	Chongqing Municipality	400000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D047928	Premature Birth
D005317	Fetal Growth Retardation

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided