Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

NCT ID: NCT03766594

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-01

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 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

Conditions

Miscarriage, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Sildenafil Citrate

Intervention Type: DRUG

Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period

Folic Acid

Intervention Type: DRUG

Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally

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).

Group Type: ACTIVE_COMPARATOR

Folic Acid

Intervention Type: DRUG

Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally

Placebo Oral Tablet

Intervention Type: DRUG

Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period

Interventions

Sildenafil Citrate

Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period

Intervention Type: DRUG

Folic Acid

Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally

Intervention Type: DRUG

Placebo Oral Tablet

Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Yakout Mohamed

Resident of O&G

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Yakout, MBBCh

Role: PRINCIPAL_INVESTIGATOR

M Yakout

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Countries

Egypt

Other Identifiers

SURPL

Identifier Type: -

Identifier Source: org_study_id