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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04051567
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
Peking University Third Hospital
Chongqing Health Center for Women and Children
Information provided by (Responsible Party):
Hongbo Qi, Ministry of Science and Technology of the People´s Republic of China

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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



Primary Outcome Measures :
  1. The incidence of preeclampsia, preterm birth, fetal growth restriction [ Time Frame: after 30 weeks of gestional age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051567


Locations
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China, Chongqing
Hongbo,Qi Recruiting
Chongqing, Chongqing, China, 400000
Contact: Hongbo Qi, Prof.    +86-023-89011101    qihongbo728@163.com   
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

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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: August 9, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pre-Eclampsia
Premature Birth
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics