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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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sildenafil citrate

50 mg single oral dose

Group Type ACTIVE_COMPARATOR

sildenafil citrate

Intervention Type DRUG

single oral dose of 50 mg

placebo

single tablet of placebo

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type OTHER

single oral dose of placebo tablet

Interventions

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sildenafil citrate

single oral dose of 50 mg

Intervention Type DRUG

placebo

single oral dose of placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Any age and any party.
2. Body mass index between 25 and 35.
3. Singleton pregnancy.
4. 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.
5. Idiopathic intrauterine growth restriction.
6. Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
7. Intrauterine growth restriction due to substance abuse (including smoking).
8. With or without past history of intrauterine growth restriction .

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No