RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

Abortion, Habitual Clinical Trial

— RECAB-ASA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823743
• Other study ID #: VGR-2170
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: July 5, 2016
• Start date: March 2008
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual

Intervention

Drug:
• Aspirin
Daily medication
• Placebo
Daily intake

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth		delivery	No
Secondary	Spontaneous abortion		up to 22 weeks	No
Secondary	Vaginal bleeding		up to 42 weeks	Yes
Secondary	Premature delivery		At delivery	Yes
Secondary	intrauterine growth retardation, measured by ultrasound as percentage deviation		up to 42 weeks	Yes
Secondary	Preeclampsia		up to 42 weeks	Yes
Secondary	Pregnancy induced hypertension		up to 42 weeks	Yes
Secondary	Placenta praevia		up to 42 weeks	Yes
Secondary	Perinatal mortality		Third trimester and 28 days after delivery	Yes
Secondary	Perinatal morbidity		28 days after delivery	Yes