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Sildenafil Citrate and Recurrent Abortion

Primary Purpose

Recurrent Abortion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sildenafil Citrate vaginal suppositories
Placebo vaginal suppositories
Uterine artery Doppler before treatment
Uterine artery Doppler after treatment
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Abortion

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Unexplained recurrent spontaneous abortion.

Exclusion Criteria:

  • Abnormal uterine cavity.
  • Luteal phase insufficiency.
  • Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
  • Antiphospholipid syndrome.
  • Inherited or acquired thrombophilia.
  • Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Sildenafil Citrate

    Placebo

    Arm Description

    Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

    Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

    Outcomes

    Primary Outcome Measures

    The difference between both groups in live birth
    Live birth is defined as an ongoing pregnancy past to the 20th week of gestation

    Secondary Outcome Measures

    Uterine artery PI at cycle day 21-23 preceding pregnancy
    The difference between both groups regard PI at cycle day 21-23 preceding pregnancy
    Uterine artery RI at cycle day 21-23 preceding pregnancy
    The difference between both groups regard RI at cycle day 21-23 preceding pregnancy
    Uterine artery PI at the twelfth week of gestation
    The difference between both groups regard PI at the twelfth week of gestation
    Uterine artery RI at the twelfth week of gestation
    The difference between both groups regard RI at the twelfth week of gestation

    Full Information

    First Posted
    March 9, 2018
    Last Updated
    March 16, 2018
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03475160
    Brief Title
    Sildenafil Citrate and Recurrent Abortion
    Official Title
    Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    December 1, 2017 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.
    Detailed Description
    Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (|IUGR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Abortion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sildenafil Citrate
    Arm Type
    Active Comparator
    Arm Description
    Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil Citrate vaginal suppositories
    Other Intervention Name(s)
    Sildenafil Citrate
    Intervention Description
    Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo vaginal suppositories
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Uterine artery Doppler before treatment
    Intervention Description
    Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
    Intervention Type
    Procedure
    Intervention Name(s)
    Uterine artery Doppler after treatment
    Intervention Description
    Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
    Primary Outcome Measure Information:
    Title
    The difference between both groups in live birth
    Description
    Live birth is defined as an ongoing pregnancy past to the 20th week of gestation
    Time Frame
    Through study completion, an average of 9 months.
    Secondary Outcome Measure Information:
    Title
    Uterine artery PI at cycle day 21-23 preceding pregnancy
    Description
    The difference between both groups regard PI at cycle day 21-23 preceding pregnancy
    Time Frame
    At cycle day 21-23 preceding pregnancy
    Title
    Uterine artery RI at cycle day 21-23 preceding pregnancy
    Description
    The difference between both groups regard RI at cycle day 21-23 preceding pregnancy
    Time Frame
    At cycle day 21-23 preceding pregnancy
    Title
    Uterine artery PI at the twelfth week of gestation
    Description
    The difference between both groups regard PI at the twelfth week of gestation
    Time Frame
    At the twelfth week of gestation.
    Title
    Uterine artery RI at the twelfth week of gestation
    Description
    The difference between both groups regard RI at the twelfth week of gestation
    Time Frame
    At the twelfth week of gestation.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unexplained recurrent spontaneous abortion. Exclusion Criteria: Abnormal uterine cavity. Luteal phase insufficiency. Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus. Antiphospholipid syndrome. Inherited or acquired thrombophilia. Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.

    12. IPD Sharing Statement

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    Sildenafil Citrate and Recurrent Abortion

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