Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss
Keywords
Abstract
Dates
| Last Verified: | 11/30/2018 |
| First Submitted: | 12/04/2018 |
| Estimated Enrollment Submitted: | 12/04/2018 |
| First Posted: | 12/05/2018 |
| Last Update Submitted: | 12/04/2018 |
| Last Update Posted: | 12/05/2018 |
| Actual Study Start Date: | 12/31/2017 |
| Estimated Primary Completion Date: | 11/19/2018 |
| Estimated Study Completion Date: | 11/30/2018 |
Condition or disease
Intervention/treatment
Drug: Sildenafil group
Drug: Folic Acid
Drug: Control group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Sildenafil group Includes 45 women who received Sildenafil citrate (Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period) and folic acid (Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally). | Drug: Sildenafil group Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period |
| Active Comparator: Control group Includes 45 women who received placebo oral tablets (apparently identical to Respatio(R) 25mg tablets, four times daily for 24 days preconceptionally starting first day of previous period) and folic acid (Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally). | Drug: Control group Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Miscarriage rate [24 gestational weeks]
Secondary Outcome Measures
1. Uterine artery resistance index [At 24 gestational weeks]
2. Uterine artery pulsatility index [At 24 gestational weeks]
