Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Miscarriage, Recurrent Clinical Trial

Official title:

Effect of Preconceptional Sildenafil Citrate Treatment in Women With Early Unexplained Recurrent Pregnancy Loss: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766594
• Other study ID #: SURPL
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 1, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage, Recurrent

Intervention

Drug:
• Sildenafil Citrate
Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period
• Folic Acid
Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally
• 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

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miscarriage rate	number of spontaneous/missed miscarriages among the participants in both groups	24 gestational weeks
Secondary	Uterine artery resistance index	Uterine artery resistance index assessed by uterine artery Doppler study in ongoing pregnancies of both groups	At 24 gestational weeks
Secondary	Uterine artery pulsatility index	Uterine artery pulsatility index assessed by uterine artery Doppler study in ongoing pregnancies of both groups	At 24 gestational weeks