| Study | Country Study period Study design |
Data source | Exposure definition | Non-exposure definition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|
|
Elsenity 2022 |
Egypt 2019 - 2021 randomized controlled trial |
A randomized controlled trial at Ain Shams University Maternity Hospital, Cairo, Egypt. | Pregnant women that took Hydroxychloroquine (200mg twice daily) for at least three months before and during gestation, in addition to low-dose aspirin and low-molecular-weight heparin (LMWH). |
unexposed, sick
Pregnant women that took placebo for at least three months before and during gestation, in addition to low-dose aspirin and low-molecular-weight heparin (LMWH). |
throughout pregnancy | 53 / 54 | ||
| 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. | ||||||||
|
Gerde 2021 |
Argentina 2004 - 2019 retrospective cohort |
The Thrombophilia and Pregnancy Loss clinic, Hospital Universitario Austral, Buenos Aires, Argentina. | Pregnancies in women that received 400 mg pf hydroxychloroquine, 100-150 mg of aspirin (until the 36th week of gestation) and 60 mg enoxaparin daily. |
unexposed, sick
Pregnancies in women that received 100-150 mg of aspirin (until the 36th week of gestation) and 60 mg enoxaparin daily. |
throughout pregnancy | 67 / 32 | None of the patients received another concomitant drug, such as steroids or a higher dose of enoxaparin other than 60 mg/daily. | |
| Careful chart review of the electronic clinical records of patients who attended the clinic. | ||||||||
|
Latino 2020 |
Argentina and France 2010 - 2017 retrospective cohort |
Acute Hospital 'Dr. Carlos G. Durand' and Hospital of Infectious Diseases 'Dr. Francisco J. Muniz', Buenos Aires, Argentina and Vascular and Coagulation Department, University Hospital Angers, Angers, France. | Patients with obstetric antiphospholipid syndrome (APS) treated with hydroxychloroquine and conventional treatment (low-dose aspirin and molecular-weight heparin). |
unexposed, sick
Patients with obstetric antiphospholipid syndrome (APS) treated with conventional treatment (low-dose aspirin and molecular-weight heparin). |
during pregnancy (anytime or not specified) | 12 / 30 | ||
| Not specified. | ||||||||
|
Mekinian 2015 |
Europe Not specified. retrospective cohort |
European multicenter study among members of European Forum on Antiphospholipid antibodies and Société Nationale Francaise de Médecine Interne (SNFMI). | Pregnancies treated by hydroxychloroquine in patients with Antiphospholipid syndrome (APS) or asymptomatic antiphospholipid (aPL) carriers, in addition to conventional APS treatment. |
unexposed, sick
Pregnancies in patients with confirmed Antiphospholipid syndrome (APS) treated by conventional APS treatment (aspirin and low-molecular weighted heparin) without hydroxychloroquine. |
during pregnancy (anytime or not specified) | 35 / 25 | ||
| Retrospective analyse of the pregnancies. For that, participant hospitals were asked to fulfill a standardized form, including date of beginning and characteristics of treatments,. | ||||||||
|
Mekinian 2016 |
France 2010 - 2014 prospective cohort |
A prospective registry of patients with clinical obstetrical fulfilling Antiphospholipid syndrome (APS) criteria, France. | Pregnancies in patients under hydroxychloroquine during pregnancy (patients with non-conventional Antiphospholipid syndrome (APS); non-APL group and confirmed APS). |
unexposed, sick
Pregancies in patients not under hydroxychloroquine during pregnancy (patients with non-conventional Antiphospholipid syndrome (APS); non-APL group and confirmed APS). |
during pregnancy (anytime or not specified) | 12 / 462 | 474 pregnancies in patients: 261 pregnancies which occurred in 65 patients with non-conventional APS ; 81 pregnancies of confirmed APS patients and 132 pregnancies of 31 patients from non-APL group. | |
| Treatments before and during all available pregnancies were prospectively recorded (Not Otherwise Specified). | ||||||||
|
Ruffatti 2018 |
20 centres (Italy, France, Spain, Russia, Poland, Argentina, UK, Israel, Emirate, Austria, Portugal) 1999 - 2016 retrospective cohort |
A multicentre, observational, retrospective study from the European Forum on Antiphospholipid Antibodies network. | Administration of Hydroxychloroquine (HCQ) daily, in addition to conventional therapy (prophylactic or therapeutic doses of heparin and low-dose aspirin), in patients with primary antiphospholipid syndrome (PAPS). |
exposed to other treatment, sick
Administration of low dose steroid, in addition to conventional therapy (prophylactic or therapeutic doses of heparin and low-dose aspirin), in patients with primary antiphospholipid syndrome (PAPS). |
during pregnancy (anytime or not specified) | 94 / 36 | ||
| The medical records were retrieved and reviewed. | ||||||||
|
Sciascia 2016 |
United Kingdom 2008 - 2014 retrospective cohort |
All the records of women attending the Lupus and Antiphospholipid Pregnancy clinic, UK. | Pregnancies in women with antiphospholipid antibodies (aPL) treated with hydroxychloroquine (HCQ) for at least 6 months prior to pregnancy and continued throughout gestation. |
unexposed, sick
Pregnancies in women with antiphospholipid antibodies (aPL) not treated with hydroxychloroquine (HCQ) during pregnancy. |
throughout pregnancy | 51 / 119 | In 26 pregnancies women received HCQ 200 mg twice daily, and in 25 pregnancies women received HCQ 200 mg once daily. | |
| Treatments were collected from patient records. | ||||||||
|
Ye 2017 |
China 2011- 2016 retrospective cohort |
A retrospective study of the Peking University Third Hospital, Beijing, China. | Prednisone (10 mg/d), Hydroxychloroquine (0.2 g bid), Low‐dose aspirin (75 mg/d) taken from the 6th day of the menstrual cycle, then injection of low‐molecular‐weight heparin (5000 U/d). Prednisone, LDA and LMWH stopped at 14 ; 36 gestational weeks and 24 h before delivery, respectively. |
unexposed, sick
Low‐dose aspirin (LDA) and low‐molecular‐weight heparin (LMWH) combination therapy taken with the same usage as former. |
during pregnancy (anytime or not specified), throughout pregnancy | 126 / 141 | ||
| The patients were retrospectively analyzed and assigned to study group (anti‐inflammation plus anticoagulation) and control group (simple anticoagulation). | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Lockshin 2012 |
USA (Seven study sites recruited) 2003 - 2011 nested case control |
The PROMISSE Study (Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid antibody Syndrome and Systemic lupus Erythematosus) is an ongoing multicenter prospective observational study. | Patients who had any Adverse pregnancy outcomes (APOs), defined as an otherwise unexplained fetal demise after 12 weeks, neonatal death prior to discharge, associated with complications of prematurity, preterm delivery prior to 34 weeks because of gestational hypertension, preeclampsia or placental insufficiency, and small for gestational age (birth weight <5th percentile). | Patients who had not Adverse pregnancy outcomes (APOs). | The patients’ physicians made all treatment decisions without knowledge of core laboratory results. Patients were evaluated monthly by an obstetrician. | during pregnancy (anytime or not specified) | 28 / 116 | Control group: sick and healthy. Indications: SLE (n=174); antiphospholipid antibody (aPL; n=87); aPL and SLE (n=57). => analyses performed on 144 patients with aPL. | |
| 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. | |||||||||
|
Yelnik 2016 |
USA, Canada, United Kingdom 2011 - 2015 nested case control |
The PROMISSE study (Predictors of pRegnancy Outcome: bioMarkers In antipho- spholipid antibody Syndrome and Systemic lupus Erythematosus), a prospective multicentre observational study. | Patients who had any Adverse pregnancy outcomes (APOs), defined as: fetal death after 12 weeks of gestation, neonatal death before hospital discharge due to complications of prematurity, preterm delivery before 36 weeks of gestation due to gestational hypertension, pre-eclampsia or placental insufficiency and small-for- gestational-age (SGA) neonate (birth weight, fifth percentile). | Patients who had not Adverse pregnancy outcomes (APOs). | Patients were followed monthly during the pregnancy. The patients’ physicians made all treatment decisions. | during pregnancy (anytime or not specified) | 13 / 31 | ||
| 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. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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