Treatment with aspirin for recurrent abortion

ISRCTN	ISRCTN88763155
DOI	https://doi.org/10.1186/ISRCTN88763155
Protocol serial number	N/A
Sponsor	Södra Älvsborgs Hospital (Södra Älvsborgs Sjukhus) (Sweden)
Funders	Regional Research Unit of Western Sweden (Sweden) (ref: VGFOUREG-12231; Diarienr. VGFOUREG-27421), Local Research Unit of Södra Älvsborgs (Sweden) (ref: VGFOUSA-10100; VGFOUSA-10114; VGFOUSA-38131)

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

Department of Obstetrics and Gynaecology
Södra Älvsborgs Hospital
Borås
501 82
Sweden

Email	lennart.blomqvist@vgregion.se

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Acetylsalicylic acid
Primary outcome measure(s)	Live birth at at least 24 gestational weeks
Key secondary outcome measure(s)	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
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 sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.