Condition category
Pregnancy and Childbirth
Date applied
22/09/2009
Date assigned
12/11/2009
Last edited
12/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lennart Blomqvist

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Södra Älvsborgs Hospital
Borås
501 82
Sweden
lennart.blomqvist@vgregion.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment with acetylsalicylic acid for idiopathic recurrent abortion: a randomised trial

Acronym

RECAB-ASA

Study hypothesis

Hypercoagulability may increase the risk of microthrombosis in spiral arteries in early pregnancy, which may contribute to the risk of early pregnancy loss. Counteraction with anticoagulants such as acetylsalicylic acid (ASA) would reduce the risk of thrombosis and hence the risk of miscarriage in patients with idiopathic recurrent abortion.

The null hypothesis is that there is no difference in birth rate in women with idiopathic recurrent abortion if treated with low-dose ASA during pregnancy compared with women treated with placebo. The alternative hypothesis is that there is a higher birth rate in patients treated with low-dose ASA compared with placebo.

Ethics approval

The Regional Board of Ethics Approval at University of Gothenburg approved on the 7th August 2007 (ref: 234-07)

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)

Condition

Idiopathic recurrent abortion

Intervention

ASA 75 mg, taken orally, given between gestational weeks 6 - 36. Controls are given placebo pills. Follow-up is until the pregnancy has ended, either as a miscarriage or as a delivery. Follow-up will end when the patient is discharged from hospital in case hospital ward was needed, as after delivery.

Intervention type

Drug

Phase

Not Applicable

Drug names

Acetylsalicylic acid

Primary outcome measures

Live birth at at least 24 gestational weeks

Secondary outcome measures

1. Miscarriage, recorded when they occur, as patients report or at specified controls at gestational weeks 9, 12, 20, 30 and 36
2. Vaginal bleeding, recorded when they occur, as patients report or at specified controls at gestational weeks 9, 12, 20, 30 and 36
3. Placenta praevia, recorded when they occur, as patients report or at specified controls at gestational weeks 9, 12, 20, 30 and 36
4. Premature delivery, measured in hospital at or after delivery
5. Intrauterine growth retardation, measured until discharge from hospital after delivery
6. Pre-eclampsia, recorded when they occur, as patients report or at specified controls at gestational weeks 9, 12, 20, 30 and 36
7. Perinatal mortality, measured until discharge from hospital after delivery
8. Perinatal morbidity, measured as Apgar score and days in neonatal intensive care unit, measured until discharge from hospital after delivery

Overall trial start date

01/01/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female participants aged 18 - 38 years
2. Idiopathic recurrent abortion, defined as at least three miscarriages between gestational weeks 6 - 12 within the same relationship. One full term pregnancy can be included.
3. Work-up according to the study protocol without a positive finding

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant exclusion criteria

1. Allergy to ASA
2. Previous participation in the study
3. Age above 37 years
4. Body mass index (BMI) above 35 kg/m^2
5. Positive findings in the work-up, requiring specific treatment for recurrent abortion
6. Concurrent treatment with ASA for other condition

Recruitment start date

01/01/2008

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Obstetrics and Gynaecology
Borås
501 82
Sweden

Sponsor information

Organisation

Södra Älvsborgs Hospital (Södra Älvsborgs Sjukhus) (Sweden)

Sponsor details

Department of Obstetrics and Gynaecology
Borås
501 82
Sweden

Sponsor type

Hospital/treatment centre

Website

http://sas.vgregion.se/

Funders

Funder type

Government

Funder name

Regional Research Unit of Western Sweden (Sweden) (ref: VGFOUREG-12231; Diarienr. VGFOUREG-27421)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Local Research Unit of Södra Älvsborgs (Sweden) (ref: VGFOUSA-10100; VGFOUSA-10114; VGFOUSA-38131)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes