• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • 0 CME Hours
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
#Grand Rounds

STRIDER RCT Results: Sildenafil for Fetal Growth Restriction

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Sildenafil, a phosphodiesterase type 5 inhibitor, has been proposed as a potential treatment for fetal growth restriction
    • Sildenafil involved in a biochemical pathway that may improve uteroplacental circulation
  • Pels et al. (JAMA Network Open, 2020) investigated whether sildenafil reduced perinatal mortality or morbidity in the context of fetal growth restriction

METHODS:

  • Placebo-controlled randomized clinical trial (RCT)
  • Sildenafil Therapy in Dismal Prognosis Early Onset Fetal Growth Restriction (STRIDER) consortium
  • Participants
    • Pregnant women between 20w0d and 27w6d with severe FGR
  • Intervention
    • Sildenafil group: 25 mg, 3 times a day
    • Placebo group
  • FGR definition
    • AC <3rd percentile or EFW <5th percentile combined with either
      • Abnormal Dopplers (unilateral or bilateral notching of the uterine artery, PI >95th percentile, MCA PI <5th percentile) or a maternal hypertensive disorder
  • Statistical analysis
    • Sample size requirement 180 participants per group based on
      • Relative risk (RR) reduction of 21% | Assume 10% loss to follow-up | Type I error of 5% | 80% power
    • The trial was stopped early when benefit on the primary outcome was determined to be unlikely
  • Primary outcome
    • A composite of perinatal mortality or major neonatal morbidity until hospital discharge

RESULTS:

  • 216 pregnant women included
  • Sildenafil group: 108 women
    • Median (IQR) gestational age: 24 weeks 5 days (23w3d to 25w5d)
    • Mean (SD) estimated fetal weight: 458 (160) g
  • Placebo group: 108 women
    • Median (IQR) gestational age: 25 weeks 0 days (22 weeks 5 days to 26 weeks 3 days
    • Mean (SD) estimated fetal weight: 464 (186) g
  • The trial was halted in due to increased incidence of neonatal pulmonary hypertension (a predefined outcome for safety monitoring)
    • Primary outcome benefit was unlikely even if the study continued to completion
    • Nor was benefit seen for secondary and exploratory outcomes
    • The committee took in to account other published and unpublished reports by the STRIDER consortium
  • The primary outcome did not differ between groups
    • Sildenafil group: 60.2%
    • Placebo group: 54.2%
    • RR 1.11 (95% CI, 0.88 to 1.40, P = 0.38)
  • Neonatal pulmonary hypertension occurred more frequently in the sildenafil group
    • Sildenafil group: 18.8% (16 neonates)
    • Placebo group: 5.1% (4 neonates)
    • RR 3.67 (95% CI, 1.28 to 10.51, P = 0.008)

CONCLUSION:

  • Sildenafil
    • Does not appear to improve severe fetal growth restriction
    • May increase the risk for neonatal pulmonary hypertension

Learn More – Primary Sources:

Maternal Sildenafil vs Placebo in Pregnant Women With Severe Early-Onset Fetal Growth Restriction: A Randomized Clinical Trial

Now You Can Get ObG Clinical Research Summaries Direct to Your Phone, with ObGFirst

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All #Grand Rounds Posts
Next >

Related ObG Topics:

RIDSTRESS RCT Results: Can Sildenafil Reduce Emergency Operative Births for Fetal Compromise?
Can Sildenafil Citrate Help in the Management of Oligohydramnios?
Does Magnesium Sulfate Provide Neuroprotection in Preterm Fetuses with Growth Restriction?

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • #Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

ObG Library

  • Hysteroscopy
  • Fertility
  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Get Guideline Alerts Direct to Your Phone
Try ObGFirst Free!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Log In to ObG First

Please log in to access OBGFirst and the 2T Ultrasound Atlas

Password Trouble?

Sign Up for ObGFirst

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!

ObG First Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site