RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

Göteborg University

Status: Completed

Conditions: Abortion, Habitual

Treatments: Drug: Placebo; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02823743

VGR-2170

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: Female

Ages: Under 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Low dose aspirin

Experimental group

Description:

75 mg aspirin orally daily from gestational week 7-35

Treatment:

Drug: Aspirin

Placebo

Placebo Comparator group

Description:

Placebo pill orally daily from gestational week 7-35

Treatment:

Drug: Placebo