The primary objective of the study is to examine muscle atrophy in fetuses with single or bilateral IPEV, in comparison to a normal population by measuring the circumference of the upper and lower legs by ultrasound examination. The length of the…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Musculoskeletal and connective tissue disorders congenital
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to examine muscle atrophy in fetuses with
single or bilateral PEV, in comparison to a normal population by measuring the
circumference of the upper and lower legs. The measurements will be performed
prenatally at 20 weeks of gestation and around 28-30 weeks of gestation,
neonates will be examined directly after birth and 6 weeks post-partum.
Secondary outcome
The length of the bones of the upper- and lower extremities and the length of
the feet will be measured to examine if there is a difference in the length of
the bones in fetuses affected with single or bilateral IPEV in comparison to
the normal population.
Background summary
Muscle- or central nervous system anomalies can induce muscle atrophy, causing
weakness of the calves and bones deformities, this could contribute to the
development of club feet (pes equinovares). We hypothesized that if this theory
holds true the muscle atrophy may already be visualized prenatally by means of
ultrasound examination in fetuses suspected of single or bilateral idiopathic
pes equinovares (IPEV) at the 20 week standard anomaly scan. We will compare
these fetuses to a normal population without structural anomalies.
Study objective
The primary objective of the study is to examine muscle atrophy in fetuses with
single or bilateral IPEV, in comparison to a normal population by measuring the
circumference of the upper and lower legs by ultrasound examination.
The length of the bones of the upper- and lower extremities and the length of
the feet will be measured in fetuses affected with single or bilateral IPEV,
the measurements will be compared to a normal population.
Study design
This is a prospective cohort study.
Study burden and risks
The extra measurements will take an extra 5-10 minutes in addition to the
standard anomaly scan or targeted ultrasound examination. The follow-up
ultrasound examination at 28 weeks of gestation will be an additional
ultrasound examination for the normal population, this is not harmful for the
fetus nor the mother. Unless there was another indication for an ultrasound
around 28 weeks (e.g. growth or placenta location). During this ultrasound
examination the regular ultrasound examination including follow-up of the
growth will be performed. The ultrasound will be combined with an appointment.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Patient should be over the age of 18 years
- Singleton pregnancy
- All fetuses with unilateral or bilateral idiopathic pes equinovares referred
to, or presenting at, Amsterdam UMC for targeted ultrasound examination around
20 weeks of gestation.
Exclusion criteria
- Patients under 18 years
- Twin pregnancy
- Multiple congenital anomalies
- An- or oligohydramnios
- History of uterus anomalies
- Septa in the uterine cavity during this pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66727.029.18 |