Back to resultsSildenafil Citrate for Treatment of Growth-restricted Fetuses
Primary Purpose
Fetal Growth Restriction
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil Citrate 25Mg Tab
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Growth Restriction
Eligibility Criteria
Inclusion Criteria:
- Maternal age ranging from 20-40 years.
- Gestational age 28-37 weeks.
Exclusion Criteria:
- Obese patients (BMI >30 kg/m2).
- Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
- Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
- Fetal distress.
- Pregnancy of multiple fetuses.
- Congenital fetal malformation or chromosomal abnormalities.
- Diastolic blood pressure more than 110 mmHg.
- Hypersensitivity to the drug.
Sites / Locations
- Ain Shams matrnity hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S
P
Arm Description
Sildenafil citrate (25mg)
placebo oral tablet
Outcomes
Primary Outcome Measures
date of delivery after Sildenafil citrate administration.
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Secondary Outcome Measures
Expected fetal weight by serial ultrasound after Sildenafil citrate administration
the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Color Doppler changes on umbilical artery
Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
neonatal outcomes as regard birth weight
the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
neonatal outcomes as regard APGAR score
the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177824
Brief Title
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
Official Title
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S
Arm Type
Experimental
Arm Description
Sildenafil citrate (25mg)
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
placebo oral tablet
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate 25Mg Tab
Intervention Description
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
Primary Outcome Measure Information:
Title
date of delivery after Sildenafil citrate administration.
Description
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Time Frame
for 6 months from the beginning of the study
Secondary Outcome Measure Information:
Title
Expected fetal weight by serial ultrasound after Sildenafil citrate administration
Description
the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Time Frame
every two weeks after drug intake for 6 months from the beginning of the study
Title
Color Doppler changes on umbilical artery
Description
Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Time Frame
weekly after drug intake for 6 months from the beginning of the study
Title
neonatal outcomes as regard birth weight
Description
the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Time Frame
for 6 months from the beginning of the study
Title
neonatal outcomes as regard APGAR score
Description
the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Time Frame
for 6 months from the beginning of the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Maternal age ranging from 20-40 years.
Gestational age 28-37 weeks.
Exclusion Criteria:
Obese patients (BMI >30 kg/m2).
Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
Fetal distress.
Pregnancy of multiple fetuses.
Congenital fetal malformation or chromosomal abnormalities.
Diastolic blood pressure more than 110 mmHg.
Hypersensitivity to the drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa mohamed Ezz el Din, MB ChB
Phone
+201000484298
Email
dr.shaimaaezz666@gmail.com
Facility Information:
Facility Name
Ain Shams matrnity hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shaimaa mohamed Ezz el Din, MB ChB
Phone
+201000484298
Email
dr.shaimaaezz666@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
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