Status:
COMPLETED
Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss
Lead Sponsor:
Ain Shams University
Conditions:
Miscarriage, Recurrent
Eligibility:
FEMALE
20-35 years
Phase:
PHASE1
Brief Summary
Recurrent unexplained spontaneous miscarriage (RSM) is defined as three consecutive pregnancy loss prior to 20 weeks from the last menstrual period. 1% to 2% of women experience RSM. Treatment of URSM...
Eligibility Criteria
Inclusion
- Age: 20-35 years.
- BMI (20-30)
- History of three or more successive unexplained recurrent miscarriage.
- Normal uterine cavity by hystrography or hysteroscopy.
- No luteal phase defects by progesterone \> 10 ng.
- Normal thyroid function (TSH, T3, T4)
- Normal lupus anticoagulant measured by activated partial throbmoplastine time (32-43 seconds).
- Normal anticardolipin (IgG \< 20 gpl and IgM \< 15 MPL measured by ELISA).
- Normal anti thyroid antibodies.
- Normal glucouse tolerance test.
- Normal parental karyotyping.
Exclusion
- Age\<20 or\>35 year
- BMI\<20 or\>30
- Systemic diseases that might affect pregnancy such as diabetes or thyroid disorders or hypertension.
- History of consanguinity.
- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13, Turner's disease …etc.).
- History of autoimmune diseases, eg: systemic lupus.
- Congenital anomaly in uterine cavity as bicornate or septate uterus.
- Luteal phase defect and corpus luteum insufficiency.
- Uterine masses as fibroid or polyps.
- Patient with patuoles os.
- patient with antiphosphlipid syndrome.
- Cigarette smoking and alcohol.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03766594
Start Date
January 1 2018
End Date
December 1 2018
Last Update
December 6 2018
Active Locations (1)
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1
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt, 002