Hydroxychloroquine Therapy In Women With Autoimmune Recurrent pregnancy Loss Refractory To Low Dose Aspirin And Hepari
- Conditions
- Fertility-female
- Registration Number
- PACTR202104858485905
- Lead Sponsor
- Maternity Hospital Faculty of Medicine Ain Shams University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main outcome was the rate of live births with or without hydroxychloroquine<br><br>
- Secondary Outcome Measures
Name Time Method 1Gestational age at delivery<br>2Rate of miscarriage with or without hydroxychloroquine.<br>3Birth weight<br>4Mode of delivery either vaginal delivery or c.s <br>5Apgar score <7 at 5 minutes <br>6Neonatal morbidity (bleeding or thrombotic complications, infections, congenital abnormalities)<br>7Days to hospital discharge following delivery(mother and neonate)<br>8Thrombotic events in the mother during pregnancy and 6 weeks postpartum<br>9Days of the neonate in special care.<br><br>