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 measure
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 (if study stopped)
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
Total final enrolment
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
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
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29972884 (added 21/08/2019)