Abortion, HabitualRECAB-ASANCT02823743
RECAB-ASA; Treatment of Recurrent Abortion With Aspirin
A study testing Aspirin in people with Abortion, Habitual, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages Up to 39 years, women only
- Conditions the study is for
- Abortion, Habitual
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- recurrent abortion (≤ 3 consecutive abortions in first trimester)
- unknown etiology after work-up
- willingness to be randomized
Who cannot join
- 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
About this study
Official title: Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
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.
- Conditions
- Abortion, Habitual
- Being tested
- Aspirin, Placebo
- Keywords
- recurrent pregnancy loss, Habitual abortion
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called ASA
Daily medication
PlaceboDrug
Daily intake
| Study group | Role | What they receive |
|---|---|---|
| Low dose aspirin | Experimental | 75 mg aspirin orally daily from gestational week 7-35 Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo pill orally daily from gestational week 7-35 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Measured: delivery
Secondary outcomes (9)
Spontaneous abortion
Measured: up to 22 weeks
Vaginal bleeding
Measured: up to 42 weeks
Premature delivery
Measured: At delivery
intrauterine growth retardation, measured by ultrasound as percentage deviation
Measured: up to 42 weeks
Preeclampsia
Measured: up to 42 weeks
Pregnancy induced hypertension
Measured: up to 42 weeks
Placenta praevia
Measured: up to 42 weeks
Perinatal mortality
Measured: Third trimester and 28 days after delivery
Perinatal morbidity
Measured: 28 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMar 2008
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, HabitualStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Annika Strandell, Göteborg University
- Investigators
- Annika Strandell, Ass.prof., Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823743
- Sponsor's protocol ID
- VGR-2170
- Acronym
- RECAB-ASA
- Status last verified
- Jul 2016
- First submitted
- 28 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02823743
- Acronym / sponsor ID
- RECAB-ASA / VGR-2170
- Conditions
- Abortion, Habitual
- Keywords
- recurrent pregnancy loss, Habitual abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Mar 2008
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose aspirin | Experimental | Drug: Aspirin75 mg aspirin orally daily from gestational week 7-35 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill orally daily from gestational week 7-35 |
Who may qualify
- Ages
- Up to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- recurrent abortion (≤ 3 consecutive abortions in first trimester)
- unknown etiology after work-up
- willingness to be randomized
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: ASADaily medication | Drug | Low dose aspirin |
| PlaceboDaily intake | Drug | Placebo |
Primary outcome
Live birth
Time frame: delivery
9 secondary outcomes
Spontaneous abortion
Time frame: up to 22 weeks
Vaginal bleeding
Time frame: up to 42 weeks
Premature delivery
Time frame: At delivery
intrauterine growth retardation, measured by ultrasound as percentage deviation
Time frame: up to 42 weeks
Preeclampsia
Time frame: up to 42 weeks
Pregnancy induced hypertension
Time frame: up to 42 weeks
Placenta praevia
Time frame: up to 42 weeks
Perinatal mortality
Time frame: Third trimester and 28 days after delivery
Perinatal morbidity
Time frame: 28 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika Strandell, Ass.prof. principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Abortion, Habitual, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.