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OpenTrials
Completed

NCT Number: NCT02362399

Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses

To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shebin Elkom, Egypt

About this study

Participants were randomized in 1:1 ratio into one of the following drug regime:

Group (I): "sildenafil citrate group" This group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate.

Group (II): "placebo group" This group consisted of 22 women who received single oral dose of placebo. All participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. One sonographer was allocated to evaluate all mothers included in the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients were admitted to the study based on the following inclusion criteria:

  • Any age and any party.
  • Body mass index between 25 and 35.
  • Singleton pregnancy.
  • Gestational age of 24 weeks or more. Gestational age was established on the basis of menstrual dates and confirmed by first or second trimester ultrasound for booked patients, however, if a difference of > 7 days or > 10 days during first or second trimester respectively, then ultrasound value was used. For unbooked patients they still have the chance to be included in our study if they can bring a scan that showed gestational age during the same period mentioned before.
  • Idiopathic intrauterine growth restriction.
  • Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
  • Intrauterine growth restriction due to substance abuse (including smoking).
  • With or without past history of intrauterine growth restriction .

Exclusion criteria

  • Intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation.
  • Any drug therapy that can affect fetal growth or fetal blood supply.
  • Maternal diseases that contraindicates the use of sildenafil citrate

Treatment and study plan

sildenafil citrate

Drug

single oral dose of 50 mg

Placebo

Other

single oral dose of placebo tablet

Primary outcomes

  1. improvement of the Doppler indices following treatment

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Al Hayat National Hospital

Other

Collaborators

  • Menoufia University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2015
Registry last updated
Apr 5, 2016

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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