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

NCT02362399 | Completed DMC

• 1 other identifier: menoufia ob/gyn 1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complication

Outcome Measures

Primary Outcomes (1)

• improvement of the Doppler indices following treatment

  9 months

Study Arms (2)

sildenafil citrate

ACTIVE COMPARATOR

50 mg single oral dose

Drug: sildenafil citrate

placebo

ACTIVE COMPARATOR

single tablet of placebo

Other: placebo

Interventions

sildenafil citrate DRUG

single oral dose of 50 mg

sildenafil citrate

placebo OTHER

single oral dose of placebo tablet

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Al Hayat National Hospital: lead
• Menoufia University: collaborator

Study Sites (1)

Menoufia University

Shebin Elkom, Egypt

Location

Related Publications (1)

• 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.

  PMID: 28345432 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 12, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

EG (1)