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Trial record 67 of 251 for:    ASPIRIN AND low-dose aspirin

RECAB-ASA; Treatment of Recurrent Abortion With Aspirin (RECAB-ASA)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02823743
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Annika Strandell, Göteborg University

Brief Summary:
The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.

Condition or disease Intervention/treatment Phase
Abortion, Habitual Drug: Aspirin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Low dose aspirin
75 mg aspirin orally daily from gestational week 7-35
Drug: Aspirin
Daily medication
Other Name: ASA

Placebo Comparator: Placebo
Placebo pill orally daily from gestational week 7-35
Drug: Placebo
Daily intake




Primary Outcome Measures :
  1. Live birth [ Time Frame: delivery ]

Secondary Outcome Measures :
  1. Spontaneous abortion [ Time Frame: up to 22 weeks ]
  2. Vaginal bleeding [ Time Frame: up to 42 weeks ]
  3. Premature delivery [ Time Frame: At delivery ]
  4. intrauterine growth retardation, measured by ultrasound as percentage deviation [ Time Frame: up to 42 weeks ]
  5. Preeclampsia [ Time Frame: up to 42 weeks ]
  6. Pregnancy induced hypertension [ Time Frame: up to 42 weeks ]
  7. Placenta praevia [ Time Frame: up to 42 weeks ]
  8. Perinatal mortality [ Time Frame: Third trimester and 28 days after delivery ]
  9. Perinatal morbidity [ Time Frame: 28 days after delivery ]


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Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrent abortion (≤ 3 consecutive abortions in first trimester)
  • unknown etiology after work-up
  • willingness to be randomized

Exclusion Criteria:

  • previous participation in the study
  • known cause of recurrent abortion, requiring specific management
  • age ≥ 40
  • BMI above 35
  • IVF pregnancy if the reason for IVF was recurrent spontaneous abortion
  • ongoing treatment with aspirin for other reason
  • Sjoegren syndrome

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): NCT02823743


Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Principal Investigator: Annika Strandell, Ass.prof. Göteborg University

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Responsible Party: Annika Strandell, Associate professor, Göteborg University
ClinicalTrials.gov Identifier: NCT02823743     History of Changes
Other Study ID Numbers: VGR-2170
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Annika Strandell, Göteborg University:
recurrent pregnancy loss, Habitual abortion

Additional relevant MeSH terms:
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Aspirin
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
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