Abortion, Habitual
Conditions
Keywords
recurrent pregnancy loss, Habitual abortion
Brief 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. 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.
Interventions
DRUGAspirin
Daily medication
DRUGPlacebo
Daily intake
Sponsors
Vastra Gotaland Region
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 39 Years
Healthy volunteers
No
Inclusion criteria
* recurrent abortion (≤ 3 consecutive abortions in first trimester) * unknown etiology after work-up * willingness to be randomized
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth | delivery |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal bleeding | up to 42 weeks |
| Premature delivery | At delivery |
| intrauterine growth retardation, measured by ultrasound as percentage deviation | up to 42 weeks |
| Preeclampsia | up to 42 weeks |
| Spontaneous abortion | up to 22 weeks |
| Placenta praevia | up to 42 weeks |
| Perinatal mortality | Third trimester and 28 days after delivery |
| Perinatal morbidity | 28 days after delivery |
| Pregnancy induced hypertension | up to 42 weeks |
Outcome results
None listed