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van CCT (UK)


- candidate number14122
- NTR NumberNTR3761
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2012
- Secondary IDsNL42283.015.12 METC Maxima Medisch Centrum
- Public TitleKLEM-studie.
- Scientific TitleLevels Lidocaine in Newborn after an Episiotomy given to Mother.
- hypothesisThere will be a relation between the level lidocaine in newborn, the level in mother and drug-delivery interval.
- Healt Condition(s) or Problem(s) studiedPerinatal transmission, Lidocaine
- Inclusion criteria1. 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 criteria1. Administration of lidocaine for other purposes than local anesthesia;
2. Administration of epinefrine together with lidocaine for episiotomy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2013
- planned closingdate1-okt-2013
- Target number of participants40
- InterventionsN/A
- Primary outcomePlasma concentration lidocaine in the newborn and in the mother on time of delivery.
- Secondary outcomeRange of plasma concentration lidocaine in 24 hours in newborn.
- Timepoints1. t=0 hour at delivery;
2. For newborn: t=1, t=3, t=6, t=12, t=24 hour.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Amphia hospital
- PublicationsN/A
- Brief summaryBackground 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.

Study design:
Prospective observational cohort study

Study population:
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)
- RECORD19-dec-2012 - 25-jul-2015

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