search
Back to results

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

Primary Purpose

Pregnancy Complication

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sildenafil citrate
placebo
Sponsored by
Al Hayat National Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Complication

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Menoufia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sildenafil citrate

placebo

Arm Description

50 mg single oral dose

single tablet of placebo

Outcomes

Primary Outcome Measures

improvement of the Doppler indices following treatment

Secondary Outcome Measures

Full Information

First Posted
February 5, 2015
Last Updated
April 3, 2016
Sponsor
Al Hayat National Hospital
Collaborators
Menoufia University
search

1. Study Identification

Unique Protocol Identification Number
NCT02362399
Brief Title
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
Official Title
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al Hayat National Hospital
Collaborators
Menoufia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sildenafil citrate
Arm Type
Active Comparator
Arm Description
50 mg single oral dose
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
single tablet of placebo
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Intervention Description
single oral dose of 50 mg
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
single oral dose of placebo tablet
Primary Outcome Measure Information:
Title
improvement of the Doppler indices following treatment
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Menoufia University
City
Shebin Elkom
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
28345432
Citation
El-Sayed MA, Saleh SA, Maher MA, Khidre AM. Utero-placental perfusion Doppler indices in growth restricted fetuses: effect of sildenafil citrate. J Matern Fetal Neonatal Med. 2018 Apr;31(8):1045-1050. doi: 10.1080/14767058.2017.1306509. Epub 2017 Mar 27.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs