|- candidate number||14122|
|- NTR Number||NTR3761|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-dec-2012|
|- Secondary IDs||NL42283.015.12 METC Maxima Medisch Centrum|
|- Public Title||KLEM-studie.|
|- Scientific Title||Levels Lidocaine in Newborn after an Episiotomy given to Mother.|
|- hypothesis||There will be a relation between the level lidocaine in newborn, the level in mother and drug-delivery interval.|
|- Healt Condition(s) or Problem(s) studied||Perinatal transmission, Lidocaine|
|- Inclusion criteria||1. Informed consent;|
2. Delivery in Amphia Hospital;
3. Administration of lidocaine in the perineum for local anesthesia;
4. Gestation period from 32 weeks;
5. For the newborn: stay in the hospital to determine glucose levels.
|- Exclusion criteria||1. Administration of lidocaine for other purposes than local anesthesia;|
2. Administration of epinefrine together with lidocaine for episiotomy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-okt-2013|
|- Target number of participants||40|
|- Primary outcome||Plasma concentration lidocaine in the newborn and in the mother on time of delivery.|
|- Secondary outcome||Range of plasma concentration lidocaine in 24 hours in newborn.|
|- Timepoints||1. t=0 hour at delivery;|
2. For newborn: t=1, t=3, t=6, t=12, t=24 hour.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. J. Huisbrink|
|- CONTACT for SCIENTIFIC QUERIES||MSc. J. Huisbrink|
|- Sponsor/Initiator ||Amphia Hospital Breda|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study:|
Lidocaine is administered to the mother as local anesthetic before performing a surgically planned incision to the perineum (episiotomy) during delivery.
In Amphia Hospital two cases have been presented with a possibility of intoxication with lidocaine, following medical signs.
Levels could not exclude an incorrect gift of lidocaine via the maternal perineum directly in the head skin of the child, or a
concentration caused by transmission via the maternal blood when it was administered locally to the mother.
Transmission of lidocaine to the child via the umbilical cord is possible. To define exactly when an intoxication will occur in
newborns, it is necessary to determine the lidocaine concentrations in a child after delivery when lidocaine is locally
administrated to the mother. It is also interesting to look at the interval between administration of lidocaine and the time of
delivery in relation to the degree of transmission of lidocaine to the child. In the current literature, no relation could be
confirmed between the concentration lidocaine in the newborn and the interval between administration and partus.
Beside this, it is important to know the pharmacokinetics of lidocaine in newborns. By research the pharmacokinetics of
lidocaine in newborns, we can estimate the duration of exposure to lidocaine and the estimated level of lidocaine
belonging to a specific time.
We aim to investigate the transmission of lidocaine from mother to child during delivery and study the pharmacokinetics of
lidocaine in newborns.
With this study we want to determine the concentration lidocaine in newborn after partus using an episiotomy in relation to
the concentration in mother. Our secondary objectives are to look at the relation between the degree of transmission of
lidocaine to the newborns and the drug-delivery interval, and the pharmacokinetical behaviour of lidocaine in newborn
after transmission of lidocaine during the partus.
Prospective observational cohort study
Fourty obstetrical women with lidoca´ne for local anesthesia before episiotomy at partus and within this group, all eligible
newborns (minimal 6, maximal 18) who had to stay in the hospital for determine a glucose curve.
Primary study parameters/outcome of the study:
The level lidocaine in the newborn on time of delivery and the level lidocaine in the mother on time of delivery.
Secundary study parameters/outcome of the study:
The range of lidocaine levels in 24 hours in the newborn.
|- Main changes (audit trail)|
|- RECORD||19-dec-2012 - 26-jan-2013|