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Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766594
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Yakout Mohamed, Ain Shams University

Study Description
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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


Condition or disease Intervention/treatment Phase
Miscarriage, Recurrent Drug: Sildenafil Citrate Drug: Folic Acid Drug: Placebo Oral Tablet Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomized into two groups: Group (A) folic acid and sildenafil citrate and Group (B) folic acid and placebo.

Folic acid (0.5 mg) will be started 3 months before conception in the two groups. Sildenafil citrate (dose: 25 mg; oral tablets, 4 times/day) or placebo will be started preconception for 24 days
Masking: Double (Participant, Care Provider)
Masking Description: Patients are randomized to receive either folic acid and sildenafil citrate or folic acid and placebo. Placebo tablets were same size and appearance of the sildenafil citrate tablets.
Primary Purpose: Treatment
Official Title: Effect of Preconceptional Sildenafil Citrate Treatment in Women With Early Unexplained Recurrent Pregnancy Loss: a Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 24 gestational weeks ]
    number of spontaneous/missed miscarriages among the participants in both groups


Secondary Outcome Measures :
  1. Uterine artery resistance index [ Time Frame: At 24 gestational weeks ]
    Uterine artery resistance index assessed by uterine artery Doppler study in ongoing pregnancies of both groups

  2. Uterine artery pulsatility index [ Time Frame: At 24 gestational weeks ]
    Uterine artery pulsatility index assessed by uterine artery Doppler study in ongoing pregnancies of both groups


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766594


Locations
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Egypt
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt, 002
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed Yakout, MBBCh M Yakout
More Information
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Responsible Party: Mohamed Yakout Mohamed, Resident of O&G, Ain Shams University
ClinicalTrials.gov Identifier: NCT03766594    
Other Study ID Numbers: SURPL
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Folic Acid
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs