CompletedPhase 1

Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Egypt90 participantsStarted 2018-01-01

Plain-language 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 is a challenging issue. The currently available lines of treatment according to simplicity of use, reliability and degree of invasiveness include corticosteroids, sildenafil citrate, aspirin, heparin and immunoglobulins (besides good antenatal care), but up to now there are no prospective randomized studies, powerful enough, to determine a significant difference between these therapeutic protocols, with any of the above mentioned pharmacological agents. Sildenafil Citrate (Viagra®), a vasodilator, is also described as an anti-inflammatory agent. While improving uterine blood flow in the proliferative phase, NO may have detrimental effects at the level of the endometrium during the implantation window. The NO- mediated release of cytokines such as tumour necrosis factor- from activated natural killer cells has been implicated as a cause of implantation failure. Based on these observations, this study attempts was made to study uterine arteries and sub-endometrial blood flow during the luteal phase in normal fertile women and in patients with Unexplained recurrent miscarriage

Who can participate

Age range20 Years – 35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Miscarriage rate

Timeframe: 24 gestational weeks

Trial details

NCT IDNCT03766594

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-20