The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

Summary

Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes.

Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival.

Study design: Multicenter nationwide randomized placebo-controlled clinical trial.

Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death.

Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.

Conditions

• Fetal Growth Restriction

Interventions

DRUG

Sildenafil

Sildenafil 25 mg three times daily orally from randomization until delivery

DRUG

Placebo

Placebo tablets three times daily orally from randomization until delivery

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• J.W. Ganzevoort, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• K Bloemenkamp, MD PhD · Leiden University Medical Center

• P von Dadelszen, Prof · University of British Columbia

• C de Groot, Prof · VU Medisch Centrum

• M.W. de Laat, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• B.W. Mol, Prof · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• M. Porath, MD PhD · Perinataal Centrum MMC Veldhoven

• J.A.M. van der Post, Prof · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• A. van Wassenaer, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-07-19

Completion

2018-07-19

Countries

• Netherlands

Study Locations