We aim to compare the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perinatal healthy survival, i.e. survival without severe neonatal morbidity at
term age.
Secondary outcome
Long-term healthy survival; fetal growth during further pregnancy; incidence of
maternal hypertensive disorders;
Background summary
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 proven therapy available. There is in vitro and in vivo evidence
to suggest that Sildenafil citrate may offer a potential therapeutic strategy
to improve uteroplacental blood flow in FGR pregnancies, and thus growth.
Study objective
We aim to compare the effectiveness of sildenafil versus placebo in achieving
healthy perinatal survival, in women with singleton pregnancies with severe
fetal growth restriction of placental origin.
Study design
Multicenter randomized double blind placebo-controlled clinical trial.
Intervention
Sildenafil 25mg or placebo tablet orally 3 times daily until fetal death,
delivery or 32 weeks of gestation (whichever comes first).
Study burden and risks
Today there is no therapy for severe placental insufficiency at these
gestational ages, current management is wait and see. There is a theoretical
small risk of fetotoxicity, but in light of the background risk of the
condition and the potential benefits these are probably negligible. Patients in
this study don't have to pay extra visits to the hospital; they will undergo
routine care. There will be one extra blood sample taken. There are no
questionnaires.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria ((I OR II) AND III):
I. at 200-276 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) <3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) <5th percentile
OR
II. at 280-296 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams
AND
III. likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)
a. the presence of uterine artery notching
b. abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
c. maternal hypertensive disorders
d. low PlGF in point-of-care assessment
Exclusion criteria
Exclusion criteria:
I. Plan to terminate pregnancy for maternal or fetal indication within days
II. Known multiple pregnancy
III. identified congenital anomalies or congenital infection
IV. Maternal age at eligibility <18 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004112-63-NL |
| CCMO | NL41894.018.12 |
| OMON | NL-OMON28320 |