Treatment with aspirin for recurrent abortion
| ISRCTN | ISRCTN88763155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88763155 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/09/2009
- Registration date
- 12/11/2009
- Last edited
- 21/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lennart Blomqvist
Scientific
Scientific
Department of Obstetrics and Gynaecology
Södra Älvsborgs Hospital
Borås
501 82
Sweden
| lennart.blomqvist@vgregion.se |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Swedish only) |
| Scientific title | Treatment with acetylsalicylic acid for idiopathic recurrent abortion: a randomised trial |
| Study acronym | RECAB-ASA |
| Study objectives | 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(s) | The Regional Board of Ethics Approval at University of Gothenburg approved on the 7th August 2007 (ref: 234-07) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2008 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 38 Years |
| Sex | Female |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Obstetrics and Gynaecology
Borås
501 82
Sweden
501 82
Sweden
Sponsor information
Södra Älvsborgs Hospital (Södra Älvsborgs Sjukhus) (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Borås
501 82
Sweden
| Website | http://sas.vgregion.se/ |
|---|---|
"ROR" |
https://ror.org/01qas6g18 |
Funders
Funder type
Government
Regional Research Unit of Western Sweden (Sweden) (ref: VGFOUREG-12231; Diarienr. VGFOUREG-27421)
No information available
Local Research Unit of Södra Älvsborgs (Sweden) (ref: VGFOUSA-10100; VGFOUSA-10114; VGFOUSA-38131)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2018 | 21/08/2019 | Yes | No |
Editorial Notes
21/08/2019: Publication reference and total final enrolment added.
