Back to resultsLow-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies
Primary Purpose
Twin Pregnancy, Preeclampsia, Preterm Birth
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin 100mg
Sponsored by
About this trial
This is an interventional prevention trial for Twin Pregnancy
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
Sites / Locations
- Hongbo,QiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LDA group
NC group
Arm Description
Outcomes
Primary Outcome Measures
The incidence of preeclampsia, preterm birth, fetal growth restriction
Secondary Outcome Measures
Full Information
NCT ID
NCT04051567
First Posted
July 9, 2019
Last Updated
October 25, 2019
Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Peking University Third Hospital, Chongqing Medical Center for Women and Children
1. Study Identification
Unique Protocol Identification Number
NCT04051567
Brief Title
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies
Official Title
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies--A Multicenter, Prospective, Open, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Peking University Third Hospital, Chongqing Medical Center for Women and Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy, Preeclampsia, Preterm Birth, Fetal Growth Restriction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
425 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LDA group
Arm Type
Experimental
Arm Title
NC group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Intervention Description
In LDA group, patients were asked for taking 100mg aspirin per night;
Primary Outcome Measure Information:
Title
The incidence of preeclampsia, preterm birth, fetal growth restriction
Time Frame
after 30 weeks of gestional age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hongbo,Qi
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo Qi, Prof.
Phone
+86-023-89011101
Email
qihongbo728@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies
We'll reach out to this number within 24 hrs