Study Type of data Exposure measurement Outcome assessment Adjustment
Elsenity, 2022 randomized controlled trial Females were divided into two groups of treatment using simple randomization procedures. Medicaments provided and administered to the patients and enforcement was measured during the prenatal follow-up visits, and all data were compiled in an electronic case record database. Prenatal follow ups and delivery in that hospital (Not Otherwise Specified). No adjustment but randomization and exclusion of women with abnormal uterine anomalies; chromosomal defects, or thyroid dysfunction: hypothyroidism or hyperthyroidism), or a prior history of venous thromboembolism, or who had retinopathy or an active cardiac disease in history, or a medical morbidity that may have an impact on the fetal outcome, such as diabetes or hypertension.
Gerde, 2021 retrospective cohort Careful chart review of the electronic clinical records of patients who attended the clinic. Careful chart review of the electronic clinical records of patients who attended the clinic. No adjustment for the considered outcomes. Exclusion of patients with other autoimmune diseases that required concomitant treatments such as steroids or immunoglobulin; twin pregnancies; and women with thrombotic events. No significant differences were seen between the groups with regard to age, weight, cardiovascular risks or history of thrombosis.
Latino, 2020 retrospective cohort Not specified. Not specified. No adjustment. Exclusion of patients with other thrombophilia, metabolic or endocrine alterations (Cushing’s disease, diabetes, thyroid disease, etc.)...
Lockshin, 2012 nested case control The patients’ physicians made all treatment decisions without knowledge of core laboratory results. Patients were evaluated monthly by an obstetrician. Adverse pregnancy outcomes (APOs) were determined as reported by the patients’ obstetrician and included in the medical record. Obstetrical members of the PROMISSE team adjudicated causes of fetal demise in equivocal cases. None.
Mekinian, 2015 retrospective cohort Retrospective analyse of the pregnancies. For that, participant hospitals were asked to fulfill a standardized form, including date of beginning and characteristics of treatments,. Retrospective analyse of the outcome of pregnancies. For that, participant hospitals were asked to fulfill a standardized form. Control group was matched by antiphospholipid (aPL) profile (type and number of positive aPL) to the group of patients with Antiphospholipid syndrome (APS) pregnancies treated by hydroxychloroquine.
Mekinian, 2016 prospective cohort Treatments before and during all available pregnancies were prospectively recorded (Not Otherwise Specified). Course and outcome of all pregnancies and delivery mode during the last pregnancy were prospectively recorded (Not Otherwise Specified). Multivariate analyses performed but not for this comparison. Factors included in multivariate analysis if p<0.05 in univariate analyses (patients’ age, type of obstetrical events, any treatment during the pregnancy, treatment regimen, patients’ group (regarding APS), presence of previous thrombosis, number of normal and pathological pregnancies).
Ruffatti, 2018 retrospective cohort The medical records were retrieved and reviewed. The medical records were retrieved and reviewed. Adjustment described but no adjusted results provided.
Sciascia, 2016 retrospective cohort Treatments were collected from patient records. Pregnancy outcome and maternal/foetal/neonatal complications were collected from patient records. None. No statistical difference of maternal age.
Ye, 2017 retrospective cohort The patients were retrospectively analyzed and assigned to study group (anti‐inflammation plus anticoagulation) and control group (simple anticoagulation). Not specified. Retrospective analyse. No adjustement. The inclusion criteria were as follows: naturally conceived singleton pregnancy; pregnancy without hypertension or diabetes; normal thyroid function before pregnancy; and no other autoimmune diseases. The exclusion criteria were as follows: embryonic chromosomal abnormalities; abnormal fetal development and infectious abortion cases.
Yelnik, 2016 nested case control Patients were followed monthly during the pregnancy. The patients’ physicians made all treatment decisions. Adverse pregnancy outcomes (APOs) were determined as reported by the patients’ obstetrician and included in the medical record. In equivocal cases, obstetrical members of the PROMISSE team adjudicated causes of fetal demise. None for the analysis of treatment. Only singleton pregnancies.

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