Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03177824

Collaborator

(none)

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Restriction	Drug: Sildenafil Citrate 25Mg Tab Drug: Placebo Oral Tablet	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Actual Study Start Date :

Mar 30, 2017

Anticipated Primary Completion Date :

Sep 30, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S Sildenafil citrate (25mg)	Drug: Sildenafil Citrate 25Mg Tab 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.
Placebo Comparator: P placebo oral tablet	Drug: Placebo Oral Tablet 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

Arm

Intervention/Treatment

Experimental: S

Sildenafil citrate (25mg)

Drug: Sildenafil Citrate 25Mg Tab

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.

Placebo Comparator: P

placebo oral tablet

Drug: Placebo Oral Tablet

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

Outcome Measures

Primary Outcome Measures

date of delivery after Sildenafil citrate administration. [for 6 months from the beginning of the study]
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 [every two weeks after drug intake for 6 months from the beginning of the study]
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 [weekly after drug intake for 6 months from the beginning of the study]
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 [for 6 months from the beginning of the study]
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 [for 6 months from the beginning of the study]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams matrnity hospital	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaimaa Mohamed Ezz el din, resident of obstetrics and gynecology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03177824

Other Study ID Numbers:

123sc

First Posted:

Jun 6, 2017

Last Update Posted:

Jun 9, 2017

Last Verified:

Jun 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Fetal Growth Retardation

Sildenafil Citrate

Study Results

No Results Posted as of Jun 9, 2017