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

Pregnancy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362399
• Other study ID #: menoufia ob/gyn 1
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: April 3, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Al Hayat National Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Patients were admitted to the study based on the following 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Complication
• Pregnancy Complications

Intervention

Drug:
• sildenafil citrate
single oral dose of 50 mg

Other:
• placebo
single oral dose of placebo tablet

Locations

Country	Name	City	State
Egypt	Menoufia University	Shebin Elkom

Sponsors (2)

Lead Sponsor	Collaborator
Al Hayat National Hospital	Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of the Doppler indices following treatment		9 months	Yes