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Completed

NCT Number: NCT02823743

RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

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.

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Key information

Conditions

Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

Up to 39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Daily medication

Other names: ASA

Placebo

Drug

Daily intake

Primary outcomes

  1. Live birth

    Time frame: delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial

Acronym: RECAB-ASA

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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