To determine the rate of transmission of prilocaine across the placentaTo determine the levels of methemoglobinemia in newborns after perineal block with prilocaine during labor (following the regimen used in our hospital)To determine the levels of…
ID
Source
Brief title
Condition
- Red blood cell disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Foetomaternal distribution of prilocaine. This will be expressed as a ratio.
2. levels of methemoglobinemia in newborns after perineal block with prilocaine
during labor (following the regimen used in our hospital)
3. Levels of methemoglobine in newborn infants which are not exposed to any
drug which can cause methemoglobinemia
Secondary outcome
Clinical examination of the newborn infant
Background summary
Prilocaine hydrochloride is a local anesthetic of the amide type which is used
for local infiltration anesthesia and for local nerve blocks. In obstetrics its
main application is the perineal block before episiotomie. Prilocaine is known
to be able to pas the placenta and to cause methemoglobinemia in the newborn
infant. This condition is caused bij an altered state of hemoglobin,
methemoglobin, in which the heme group is oxidez to its ferric state.
Methemoglobinemia causes cyanosis which does not respond to the application of
oxygen. Children under the age of 3 months are at a higher risk of developing
methemoglobinemia due to their lower levels of methemoglobin reductase enzyme
responsible of reducing oxidized and the high level of fetal hemoglobin which
is more easily oxidized than adult haemoglobin.
Study objective
To determine the rate of transmission of prilocaine across the placenta
To determine the levels of methemoglobinemia in newborns after perineal block
with prilocaine during labor (following the regimen used in our hospital)
To determine the levels of methemoglobin in normal newborn infants whose
mothers did not receive perineal block
To determine the relation between levels of methemoglobin and clinical signs in
the newborn
Study design
An observational, prospective, case/control (pilot) study.
Intervention group: Mothers and their newborn infants after prilocaine
administration
Cotrol group: Mothers and their newborn infants without prilocaine
administration
Observations are done on bloodsamples taken from the umbilical cord, the mother
and the newborn and by clinical examination of the newborns.
T0 (Immediately after birth):
Evaluation of the clinical condition of the newborn child
Maternal blood sampling: Prilocaine level
Blood sampling from umbilical cord: Prilocaine, methemoglobine, bloodgas
analysis
T1 (two hours after birth):
Evaluation of the clinical condition of the newborn child
Blood sampling of the child: Prilocaine, methemoglobine, blood gas analysis
In the control group prilocaine levels will not be measured en thus no maternal
blood will be needed.
Those investigators evaluating the clinical condition of the child will be
blinded for all results of the blood tests and the alocation to the respective
study groups
Study burden and risks
Nature and extent of the burden:
1 venapunction on the mother and one heel prick on the newborn infant
1 extra physical examination of the newborn infant appart fron the standard one
in our wards immediately after birth.
We estimate that this is not a big burden.
Risks associated with the participation:
The risks named above: local bleeding and hematoma following vena punction and
heel prick.
Oosterpark 9
1091AC Amsterdam
Nederland
Oosterpark 9
1091AC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
All women who will give birth in our hospital and consent in participating in our study and their newborn infants
Exclusion criteria
Women with any form of hereditary methemoglobinemia.
Women how are carriers or suffer from one or more of the following illnesses: G6PD deficiency or any form of hemoglobinopathy.
Women who, at the time of labour, receive other drugs which can cause methemoglobinemia.
Women who would want to use the umbilical cord blood for other purposes such as stem cell donation.
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 | NL17014.067.07 |