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Completed

NCT Number: NCT03475160

Sildenafil Citrate and Recurrent Abortion

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.

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Key information

Conditions

Recurrent Abortion Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil Citrate vaginal suppositories

Drug

Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Other names: Sildenafil Citrate

Placebo vaginal suppositories

Drug

Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Other names: Placebo

Uterine artery Doppler before treatment

Procedure

Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy

Uterine artery Doppler after treatment

Procedure

Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation

Primary outcomes

  1. The difference between both groups in live birth

    Time frame: Through study completion, an average of 9 months.

    Live birth is defined as an ongoing pregnancy past to the 20th week of gestation

Secondary outcomes

  1. Uterine artery PI at cycle day 21-23 preceding pregnancy

    Time frame: At cycle day 21-23 preceding pregnancy

    The difference between both groups regard PI at cycle day 21-23 preceding pregnancy

  2. Uterine artery RI at cycle day 21-23 preceding pregnancy

    Time frame: At cycle day 21-23 preceding pregnancy

    The difference between both groups regard RI at cycle day 21-23 preceding pregnancy

  3. Uterine artery PI at the twelfth week of gestation

    Time frame: At the twelfth week of gestation.

    The difference between both groups regard PI at the twelfth week of gestation

  4. Uterine artery RI at the twelfth week of gestation

    Time frame: At the twelfth week of gestation.

    The difference between both groups regard RI at the twelfth week of gestation

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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