Fertility-female
Conditions
Interventions
Hydroxychloroquine
placebo and Aspirin and LMWH
Sponsors
Maternity Hospital Faculty of Medicine Ain Shams University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women, with a history of autoimmune-related recurrent pregnancy loss refractory to standard treatment only, which have had : (a) One or more unexplained deaths of morphologically normal fetuses at or after 10 weeks gestation after documentation of fetal life. (b) One or more premature births of morphologically normal fetuses at or before 34 weeks gestation because of eclampsia or severe preeclampsia or features consistent with placental insufficiency. (c) Three or more consecutive, unexplained spontaneous abortions before 10 weeks gestation, after exclusion of maternal anatomic or hormonal and couple chromosomal abnormalities. 2) Age 18-45 years 3) Body Weight >45 kg
Exclusion criteria
Exclusion criteria: 1. Pregnant woman 2. Abnormal uterine anomalies at hysterosalpingography/hysteroscopy or hydrosonography 3. Karyotyping abnormalities within the couple 4. Thyroid dysfunction (hypothyroidism or hyperthyroidism or antithyroid Abs) 5. Other medical morbidity affecting fetal outcome e.g DM and hypertension. 6. Allergy or adverse event to HCQ. Hypersensitivity to the active substance, 4-aminoquinoline or any of the compounds of the IMP or placebo 7. Current treatment with HCQ 8. Body weight<45 kg 9. Psoriasis 10. Uncontrolled epilepsy 11. Other severe active comorbidities (human immunodeficiency virus, hepatitis B) 12. History of retinopathy 13. Previous pregnancy failure on HCQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome was the rate of live births with or without hydroxychloroquine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Gestational age at delivery 2 Rate of miscarriage with or without hydroxychloroquine. 3 Birth weight 4 Mode of delivery either vaginal delivery or c.s 5 Apgar score <7 at 5 minutes 6 Neonatal morbidity (bleeding or thrombotic complications, infections, congenital abnormalities) 7 Days to hospital discharge following delivery(mother and neonate) 8 Thrombotic events in the mother during pregnancy and 6 weeks postpartum 9 Days of the neonate in special care. | — |
Countries
Egypt
Contacts
Public ContactMohammed Abdelrazeq
Assistant Lecturer in department of Obstetric and Gynecology at Faculty of MedicineAin Shams University
Outcome results
None listed