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Intrauterine Growth Restriction (IUGR)Phase 2/3STRIDERCanNCT02442492

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

A Phase 2/3 study testing Sildenafil in people with Intrauterine Growth Restriction (IUGR) and Fetal Growth Restriction (FGR), run by University of British Columbia at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Sildenafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
5 sitesCanada
Study dates
Jan 2017to Apr 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gestational age from 18+0 - 27+6 weeks
  • AND
  • EO IUGR, defined as
  • ultrasound (U/S) measurement of the fetal abdominal circumference (AC) <10th percentile for gestational age and/or documented reduced fetal growth velocity complicating either a prior EO IUGR with adverse perinatal outcome or abnormal uterine artery waveform in the index pregnancy;
  • OR
  • U/S estimate of fetal weight (EFW) <700g
  • AND
  • Serum PlGF < 5th percentile for gestational age

Who cannot join

  • known fetal aneuploidy
  • known fetal anomaly/syndrome/congenital infection confirmed at the time of enrolment
  • decision made to terminate pregnancy
  • current cocaine or vasoconstrictor use (e.g. crystal meth) (risk of acute cardiac events)
  • contraindication to sildenafil therapy, e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil
  • known HIV positive status (due drug-drug interaction between sildenafil and antiretrovirals)
Show all 9Show fewer
  • receiving peripheral alpha-blockers (e.g. prazosin)
  • prior participation in a STRIDER trials
  • pre-eclampsia or gestational hypertension diagnosed

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • CHU de Quebec - Universite Laval

    Québec, Quebec, G2N 0B2

  • BC Women's Hospital/University of British Columbia

    Vancouver, British Columbia, V7H3N1

Other trials in Canada

About this study

Official title: STRIDER Canada: A Randomized Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (Canada)

Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. There is no known treatment for placental IUGR. Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise. However, remote from term, delivery is associated with significant perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy.

Read the detailed description

STRIDER Canada is one of a consortium of STRIDER randomised controlled trials (RCTs) each of which is designed to determine whether or not maternal treatment with oral sildenafil citrate improves perinatal outcomes in pregnancies complicated by EO IUGR without increasing risks to the mother.

STRIDER Canada is designed as investigator-initiated double-blind, randomised placebo-controlled trial of 90 women with a diagnosis of early-onset intrauterine growth restriction with an intention-to-treat analysis. 90 Women with affected pregnancies will be recruited and randomised to receive either sildenafil or placebo.

Women reviewed in the participating fetal medicine with a diagnosis of a pregnancy affected by early-onset IUGR between 18+0 and 27+6 weeks of gestation and serum PlGF levels less than 5th percentile for gestational age will be considered for randomisation. In Canadian STRIDER, the treatment with either sildenafil or placebo (25 mg 3 times per day) will be applied from the time of randomisation until delivery, or up to 31+6 weeks of gestation whichever comes first.

All patients randomly assigned to one of the treatments will be analysed together, regardless of whether or not they completed or received that treatment, on an intention to treat basis.

Being tested
Sildenafil, Placebo
Keywords
sildenafil, IUGR, FGR, STRIDER
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SildenafilDrug

    Sildenafil 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.

  • PlaceboDrug

    Placebo 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.

Study groups in NCT02442492
Study groupRoleWhat they receive
SildenafilActive comparatorSildenafil 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.
Receives: Drug: Sildenafil
PlaceboPlacebo comparatorPlacebo 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups

    Measured: 6 weeks after postpartum

Secondary outcomes (4)

  1. live birth

    Measured: at delivery if alive

  2. survival to hospital discharge

    Measured: measured at the final hospital discharge (average upto 6 weeks postpartum)

  3. intact survival (defined as survival to estimated due date (EDD) without evidence of severe central nervous system [CNS] injury [by ultrasound and/or magnetic resonance imaging (MRI)])

    Measured: measured at estimated due date (EDD)

  4. composite non-CNS (Central Nervous System) severe morbidity (one/more of bronchopulmonary dysplasia requiring supplemental oxygen on hospital discharge, ≥grade 3 retinopathy of prematurity, or necrotising enterocolitis)

    Measured: up to 6 weeks after postpartum or final discharge which ever is sooner

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2015 (estimated)
  2. Study startJan 2017
  3. Primary completionJul 2018
  4. Study completionApr 2019

Why it stopped: Trial terminated following Dutch DSMB recommendation for their Study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02442492
Sponsor's protocol ID
H15-00899
Acronym
STRIDERCan
Status last verified
Feb 2020
First submitted
5 May 2015
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • von Dadelszen P, Audibert F, Bujold E, Bone JN, Sandhu A, Li J, Kariya C, Chung Y, Lee T, Au K, Skoll MA, Vidler M, Magee LA, Piedboeuf B, Baker PN, Lalji S, Lim KI. Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: ethical, methodological, and pragmatic considerations. BMC Res Notes. 2022 Jul 7;15(1):244. doi: 10.1186/s13104-022-06107-y.

    PubMed 35799272

  • Pels A, Kenny LC, Alfirevic Z, Baker PN, von Dadelszen P, Gluud C, Kariya CT, Mol BW, Papageorghiou AT, van Wassenaer-Leemhuis AG, Ganzevoort W, Groom KM; international STRIDER Consortium. STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials. BMC Pregnancy Childbirth. 2017 Dec 28;17(1):440. doi: 10.1186/s12884-017-1594-z.

    PubMed 29282009

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sildenafil in people with Intrauterine Growth Restriction (IUGR) and Fetal Growth Restriction (FGR), run by University of British Columbia at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Trial terminated following Dutch DSMB recommendation for their Study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups (time frame: 6 weeks after postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02442492, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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