NCT03177824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

April 26, 2017

Last Update Submit

June 8, 2017

Conditions

Fetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • 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.

    for 6 months from the beginning of the study

Secondary Outcomes (4)

  • 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

  • Color Doppler changes on umbilical artery

    weekly after drug intake for 6 months from the beginning of the study

  • neonatal outcomes as regard birth weight

    for 6 months from the beginning of the study

  • neonatal outcomes as regard APGAR score

    for 6 months from the beginning of the study

Study Arms (2)

S

EXPERIMENTAL

Sildenafil citrate (25mg)

Drug: Sildenafil Citrate 25Mg Tab

P

PLACEBO COMPARATOR

placebo oral tablet

Drug: Placebo Oral Tablet

Interventions

Sildenafil Citrate 25Mg TabDRUG

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.

S
Placebo Oral TabletDRUG

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

P

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age ranging from 20-40 years.
  • Gestational age 28-37 weeks.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams matrnity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

shaimaa mohamed Ezz el Din, MB ChB

CONTACT

+201000484298dr.shaimaaezz666@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident of obstetrics and gynecology

Study Record Dates

First Submitted

April 26, 2017

First Posted

June 6, 2017

Study Start

March 30, 2017

Primary Completion

September 30, 2017

Study Completion

October 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

EG(1)