Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Overview

The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 30, 2017

Interventions

  • 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.
  • 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

Arms, Groups and Cohorts

  • Experimental: S
    • Sildenafil citrate (25mg)
  • Placebo Comparator: P
    • placebo oral tablet

Clinical Trial Outcome Measures

Primary Measures

  • date of delivery after Sildenafil citrate administration.
    • Time Frame: 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 Measures

  • Expected fetal weight by serial ultrasound after Sildenafil citrate administration
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shaimaa Mohamed Ezz el din, resident of obstetrics and gynecology – Ain Shams University
  • Overall Contact(s)
    • shaimaa mohamed Ezz el Din, MB ChB, +201000484298, dr.shaimaaezz666@gmail.com

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