Medtronic Award Paper presented at CANN Conference, Halifax, N.S., June 2009
Intrathecal baclofen and pregnancy: Implications for clinical care
By Margo DeVries-Rizzo, Diny Warren, Gail Delaney, Simon Levin, Craig Campbell and Sandrine DeRibaupierre
Intrathecal baclofen use during pregnancy is rare. There are no
Pregnancy in patients with intrathecal baclofen (ITB) pumps
controlled studies of its use during pregnancy. A literaturesearch revealed only five reported cases of ITB use during
is rare. To our knowledge, only five reported cases of pregnan-
pregnancy. Four had implanted pumps and one of these cases
cy exist in the literature. Thus, there is little experience to
delivered two healthy infants while having an ITB pump
inform health care practitioners about the maternal and fetal
(Dalton et al., 2008; Delhaas & Verhagen, 1992; Munoz &
safety of ITB or its efficacy throughout pregnancy.
Marco, 2000; Roberts et al., 2003). One other case report exists
There are no reports of a pregnant female with an implanted
with ITB being delivered in bolus doses given once daily via an
ITB pump having a spontaneous, vaginal delivery at term. As
external catheter during the last trimester of pregnancy
far as we know, this is the first case described in the literature.
(Engrand et al., 2001). This accounts for six infants identified
Additionally, current literature does not address clinical impli-
in the literature born to females with ITB during pregnancy.
All cases reported in the literature required ITB for manage-
This paper reviews literature to date and presents unique
ment of spasticity. The four cases of implanted ITB pumps dur-
aspects of our patient. It also discusses clinical implications for
ing pregnancy were females aged 23 to 37. All cases with an
treating a pregnant patient with an ITB pump. The intent of
implanted ITB pump delivered prematurely (32 to 37 weeks ges-
this paper is to advance our body of knowledge in caring for
tation) by planned cesarean section. One female had her pump
pregnant clients with ITB pumps and reassure families about
implanted at 30 weeks gestation due to increasing spasticity and
the safety and efficacy of this treatment.
spasticity-related pain (Roberts et al., 2003). The remainingthree cases had their ITB pumps implanted 15 months to four
years prior to conception. Doses of ITB during gestation ranged
Baclofen, a well-known antispasmodic and muscle relaxant, is
from 140 ucg/d to 1400 ucg/d. One additional case was report-
a common treatment for spasticity. This GABA agonist, more
ed of a teenage primip with tetanus who required an external-
commonly used as an oral agent, can be continuously delivered
ized catheter for ITB bolus doses (250–1500 ucg once daily) who
to the intrathecal space via a surgically implanted battery-
had a 32-week neonate by spontaneous, vaginal delivery
powered pump. Since its first use in 1983, its efficacy as an
(Engrand et al., 2001). She received daily ITB boluses for 21
intrathecal preparation has been increasingly recognized.
days, which were discontinued eight days prior to delivery and
Direct delivery and binding of the drug to spinal GABA
replaced with an increase in intravenous diazepam.
receptors in much smaller doses than required orally results in
Concern exists regarding ITB use during pregnancy given
a marked reduction in systemic side effects (Albright, 1999).
reports that oral doses exceeding seven to 12 times the recom-mended human dose could be teratogenic in animal studies(Thomson Micromedex, 2008). Additionally, there is a lack of
Le baclofen intrathécal et la grossesse :
controlled human studies. The manufacturer’s current recom-
les implications pour les soins cliniques
mendation for oral baclofen use in pregnant women is restrict-ed for situations where the potential benefit justifies the poten-
tial risk to the fetus (Thomson Micromedex, 2008; Munoz &
La grossesse chez des patientes avec une pompe à baclofen
Marco, 2000). The Class C rating does not distinguish between
intrathécal (BIT) est rare. À notre connaissance, seulement
the levels of risk of the oral preparation as compared with the
cinq cas rapportés de grossesse existent dans les écrits. Ainsi, il
intrathecal solution. However, results indicate plasma baclofen
y a peu d’expérience pour informer les professionnels de la
levels in patients treated with intrathecal baclofen are often
santé sur la sécurité maternelle et fœtale du BIT ou de son
too low to be detected with routine testing methods, suggest-
ing minimal systemic exposure and probably a lack of placen-tal transfer to the fetus (Albright, 1999).
Il n’y a pas de rapport d’accouchement vaginal, spontané, et àterme de femme enceinte avec une pompe implantée BIT. À
To date, no problems have been identified for either the moth-
notre connaissance, ceci est le premier cas décrit dans la
er or the child in the reported cases with an ITB pump with
littérature. De plus, les écrits courants n’adressent pas les
continuous infusion (Dalton et al., 2008; Delhaas & Verhagen,
implications cliniques pour ces patientes.
1992; Roberts et al., 2003). One case report exists where aneonate was reported to be hypotonic during the first few days
Cet article fait la recension des écrits à ce jour et présente l’aspect
of life. Although, in this case, the ITB boluses were changed to
unique de notre patiente. Il discute aussi des implications
intravenous diazepam at least one week prior to delivery, no
cliniques dans le traitement de femmes enceintes avec une pompe
etiology for the infant’s presentation is discussed in the article.
BIT. Le but de cet article est d’avancer notre corps de connaissance
The neonate was discharged home nine days after delivery
dans le soin de clientes enceintes avec une pompe BIT et rassurer
with no follow-up report. Two infants were followed until 24
les familles sur la sécurité et l’efficacité de ce traitement.
months of age and demonstrated normal development
Canadian Journal of Neuroscience Nursing • Volume 31, Issue 3, 2009
(Munoz & Marco, 2000; Roberts et al.). To date, no evidence of
The patient and her infant were discharged home on day three.
teratogenicity has been reported in pregnant females with ITB
She remained on her prenatal ITB dose of 440 ucg/day. She was
pumps (Dalton et al., 2008; Delhaas & Verhagen, 1992;
noted to have slightly increased lower extremity tone during a
Engrand et al., 2001; Munoz & Marco; Roberts et al.).
routine assessment six weeks after the birth of her infant and herITB dose was increased to 480 ucg/day. She remained on this
dose until 12 months after delivery. In March 2009, she report-
We report the first case of a young primip with an implanted
ed a mild increase in spasticity in her lower extremities and her
ITB pump who delivered a full-term, healthy infant by sponta-
ITB dose was increased to 529 ucg/day. She remains on this dose
neous vaginal delivery in 2008. The cognitively intact 18-year-
and continues to be the primary caregiver for her infant. The
old developed spastic diplegia after being diagnosed with trans-
infant was followed for 15 months and demonstrated normal
verse myelitis in 1995, at the age of six years. She had significant
growth and development and no evidence of teratogenicity.
hypertonicity and spasticity of her lower extremities. She is pri-marily wheelchair dependent. She developed progressive lum-
Clinical implications for practice
bar scoliosis in her early teenage years and had Luque spinal
Intrathecal baclofen has been used since the mid 1980s (Penn
instrumentation implanted in 2005 at the age of 16.
& Kroin, 1985). Although clinical management of patients withintrathecal baclofen pumps has been addressed in the litera-
Oral baclofen had been tried at therapeutic dosages and was
ture (Bhimani, 2008), none exists regarding clinical manage-
unsuccessful. Regular physiotherapy was not preventing the
ment of pregnant patients with intrathecal baclofen pumps.
development of contractures. An ITB trial was done and
One recent case report highlighted the importance of a multi-
demonstrated positive results. The ITB pump was implanted in
disciplinary approach for a pregnant patient on oral baclofen
February 2001, with the catheter tip placed at thoracic level 12.
to treat reflex sympathetic dystrophy (Moran et al., 2004).
Shortly after pump implantation, the patient reported dramatic
Additional literature suggests a multidisciplinary approach
improvement in lower limb tone and ability to perform activities
works best for obstetric management of the pregnant patient
of daily living, including increased ease with self-catheteriza-
with a spinal cord injury (Pereira, 2003). This section will focus
tion. She also experienced decreased pain at night, as a result of
on some of the unique challenges we faced with our pregnant
decreased muscle spasms. Her caregivers also noted improve-
patient with an ITB pump. We present collaborative-care rec-
ment with assistance with ADLs. Elective reimplantation of the
ommendations since no standards of practice exist to date.
pump, due to battery depletion, was done in April 2006 in con-junction with scoliosis surgery revision. In May 2006, she devel-
oped right femoral vein thrombosis, which was managed with
Our pediatric intrathecal baclofen program is affiliated with a
subcutaneous low-molecular-weight heparin for six months.
larger citywide adult baclofen program. This group encom-
Etiology for the DVT was not felt to be related to the ITB
passes multidisciplinary teams from two major health care
pump. In March 2007, prior to her pregnancy, she developed
centres located across several hospital sites within the city.
a DVT in her left leg secondary to immobility. Once again she
Primary members are nurses, neurology nurse practitioners,
was placed on low-molecular-weight heparin and continued
neurologists, physiatrists, neurosurgeons, physiotherapists,
with this treatment throughout pregnancy. After delivery she
social workers and psychologists. The multidisciplinary,
was placed on an oral antithrombolytic agent indefinitely.
across-the-lifespan mandate is designed to facilitate collabora-tion resulting in improved patient care and education. This
The patient became pregnant in mid-2007 at the age of 18. At
team approach facilitates discussion of interesting cases and
the start of the pregnancy, the patient was on an intrathecal
transitioning of pediatric patients to the adult setting to
baclofen dose of 375 ucg/day. No increased spasticity was noted
enhance seamless health care. At the age of 18, patients are
during the early part of her first trimester. During the fourth
transitioned to the adult spinal cord injury (SCI) program. The
month of gestation, a mild increase in tone and urine retention
pediatric team continues to provide clinical support and liais-
was noted during routine assessment and the ITB dosage was
es with the adult program until the patients are fully trans-
increased to 400 ucg/day. By the fifth month of gestation, urine
ferred. This multidisciplinary perspective and approach
retention had improved and was being managed with intermit-
addresses the biopsychosocial needs unique to this population.
tent catheterizations. However, spasticity had increased in herlower extremities and her ITB dosage was increased to 440
However, given the paucity of literature and our patient’s etiol-
ucg/day. She was managed on this dose for the remainder of her
ogy, including several comorbidities, a broader multidiscipli-
pregnancy and initial postpartum period. The patient reported
nary team including several sub-specialties was implemented
that although her spasticity increased during pregnancy and she
within the first trimester. Thus, the development of a multidis-
required dose adjustments of ITB, the spasticity never signifi-
ciplinary team is essential early in the pregnancy to address the
cantly impaired her ability to perform activities of daily living.
unique and evolving needs of these patients. It allows for a pre-ventative, proactive approach and anticipates the need for reac-
Unassisted labour occurred at 38 weeks gestation and a healthy
tive care when necessary. It is essential for the patients and their
male infant was born by spontaneous vaginal delivery. The
families to be well informed early in the pregnancy and include
intrapartum period was complicated by a urinary tract infec-
them as an integral part of the decision-making process.
tion and intravenous antibiotics were required in the immedi-ate postpartum period. No significant changes in spasms or
spasticity were noted. The patient was able to participate inthe care of her infant on the first day of delivery and success-
Our patient was referred to a gynecologist for a prenatal assess-
ment in her first trimester. Her underlying SCI and comorbidi-
Volume 31, Issue 3, 2009 • Canadian Journal of Neuroscience Nursing
ties, which included hip dysplasia, necessitated an assessment
Although our case demonstrates a spontaneous vaginal delivery
for risks associated with preterm labour, increased risks for
is possible, a labour plan that includes consideration of a caesar-
infection and increased risks for operative delivery. In addition
ian section is recommended. The obstetrician has to be aware of
to routine pregnancy investigations, close monitoring occurred
the position of the pump in order to plan the C-section, if nec-
on a regular basis with decreasing intervals prior to delivery.
essary. Usually the pump is inserted higher and more laterallythan the C-section incision and, therefore, should not interfere.
Although a theoretical risk exists regarding thrombotic compli-cations in pregnant patients with a chronic SCI, there is little
evidence to support this. Additionally, no evidence exists to sug-gest patients with ITB pumps have an increased risk of DVTs.
In the five ITB cases reported to date, three patients required
Our patient was followed closely by hematology specialists and
no increases of ITB (Munoz & Marco, 2000; Dalton et al., 2008).
maintained on thrombosis prophylaxis due to her pre-existing
One patient required a 14% increase (Delhaas & Verhagen, 1992)
DVT. However, current antithrombotic recommendations for
while another patient with an ITB pump, implanted at 30 weeks
each case are to be evaluated individually (Pereira, 2003).
gestation due to increasing spasticity, required a 250% increase(Roberts et al., 2003). Our patient required a 17% increase during
Although pregnancies in patients with SCI present interesting
her pregnancy, but did not experience any significant impact of
challenges attributed to loss of autonomic control below the
spasticity or spasms on her ADLs or bladder and bowel function.
level of the spinal cord lesion, current evidence suggests that
She also experienced no side effects to increases in ITB baclofen.
most patients with an SCI will have successful deliveries atterm. There is also no increased risk for post-term delivery
Increased spasticity during pregnancy may result from multi-
(Pereira, 2003). Literature on pregnant patients with ITB
ple etiologies. In addition to the underlying neuromuscular
pumps suggests pre-term delivery has been planned rather
disorder, the pregnancy, bladder and bowel changes, alter-
than allowing the pregnancy to go to term (Delhaas &
ations in skin integrity and seating issues may exacerbate spas-
Verhagen, 1992; Munoz & Marco, 2000; Roberts et al., 2003).
ticity. Close evaluation of multiple etiologies and their impact
Our patient did receive an assessment with the pre-admission
on the patient and their ability to perform ADLs is essential.
clinic in case a caesarian section would be required and a
ITB therapy is well known to decrease spasticity and spasms
comprehensive labour plan was established.
and improve patient’s abilities to perform activities of daily liv-ing (Bhimani, 2008). It is important to include assessments
Intrathecal baclofen pump
using validated tools, such as the Ashworth Scale (Ashworth,
Since the pump is implanted subcutaneously and above the
1964), as well as taking the patient’s perspective into account
abdominal muscle, there should be no interference with the
when evaluating spasticity and its impact on ADLs during
expanding uterus or abdominal organs (Medtronic, 2004).
pregnancy. ITB dosages should be adjusted to facilitate contin-
Although the pump may appear more prominent as the abdom-
ued independence both before and after the birth of the infant.
inal girth expands, there should be no risk for pump dehiscence.
Assessments for devices and equipment required to facilitate
Health care practitioners may find accessing the ITB pump actu-
independence with ADLs and infant care need to be addressed
ally becomes easier due to its prominence. However, the grow-
early in the pregnancy to ensure availability of resources.
ing abdomen may interfere with restraints and devices requiredfor mobility and adjustments to seating may be required.
No literature exists describing tubing disconnections or pump
Effects of ITB on bladder function are unknown. Alterations in
migration during pregnancy. Extra tubing length is routinely
function are primarily attributed to the underlying etiology for
implanted at the time of pump implantation and looped behind
the spasticity. Genitourinary complications are well recognized
the pump to allow for expansion changes associated with weight
in patients with underlying SCI and asymptomatic urinary tract
gain and growth. Therefore,
issues with pump tubing must be
infections occur in a high number of pregnant patients with
kept in mind during the expansion of the abdomen, though no
SCI (Pereira, 2003). Our patient required an increase in the fre-
specific monitoring is required. Our patient experienced no
quency of intermittent catheterizations during the initial part
difficulties with the implanted ITB pump or pump tubing.
of her first trimester and the latter part of her third trimester.
The etiology for this was unclear. During the latter part of her
Regularly scheduled clinical assessments of response to ITB are
first trimester she was noted to have an asymptomatic UTI for
recommended. Spasticity has been noted to increase with preg-
which she was treated and then placed on antibiotic prophylax-
nancy (Dalton et al., 2008; Roberts et al., 2003), so it is important
is. She presented during labour, febrile and with an unrecog-
to differentiate between evolving spasticity related to pregnancy
nized UTI. We recommend very close monitoring for evidence
and other health conditions versus mechanical complications,such as tubing dislodgement, disconnection or pump malfunc-
of lower and upper urinary tract infections in pregnant patients
tion. Observance of presentation of acuity of symptoms is
with an ITB pump who have a neurogenic bladder regardless of
important. Mechanical complications need to be included in
etiology, and are performing self-catheterizations.
the differential diagnosis when acute changes in spasticity pres-ent. If concerns exist regarding catheter placement or mechan-
ical delivery of ITB, a bolus can be programmed and effective-
One identified risk of pregnant patients with SCI is that of
ness observed within the clinical setting. This method of eval-
unrecognized contractions, which may result in an unattended
uation would be recommended initially over x-ray examination
delivery. Our patient has some preserved sensation and was
to avoid unnecessary radiation exposure.
able to recognize subtle contractions. It is important to provide
Canadian Journal of Neuroscience Nursing • Volume 31, Issue 3, 2009
education regarding recognizing sympathetic nervous system
effects on the infant post-natally. It also suggests a pregnant
symptoms such as increased spasticity, shortness of breath and
female with an ITB pump, who has spinal instrumentation
leg or abdominal spasms as a probable indication of labour.
and a previous history of DVT, is able to have a spontaneous
However, this needs to be differentiated from symptoms of ITB
vaginal delivery at term. A multidisciplinary approach that
withdrawal. We recommend patients be taught uterine palpa-
integrates preventative and proactive care into the health
tion techniques, how to time contractions and to be aware of
care spectrum is recommended. Additionally, patient and
their baseline pulse, blood pressure and temperature readings.
family involvement in the health care decision-making
Plasma baclofen levels are essentially undetectable in both
About the authors
children and adults receiving therapeutic chronic intrathecal
Margo DeVries-Rizzo, BScN, MScN, RN(EC), Nurse
baclofen infusion dosages (Albright, 1999). There have been
Practitioner, Pediatric Neurology at Children’s Hospital,
no adverse events or signs and symptoms of withdrawal relat-
London Health Sciences Centre, Adjunct Assistant Professor,
ed to intrathecal baclofen reported in newborns of women
Faculty of Health Sciences, University of Western Ontario.
with a chronic intrathecal baclofen pump (Dalton et al., 2008;
Diny Warren, RN, CCRN, recently retired clinic nurse from
Delhaas, 1992; Munoz & Marco, 2000; Roberts et al., 2003).
Evidence does exist for close monitoring of infants born to
Spinal-Cord Injury (SCI) Program, Parkwood Hospital, St.
mothers on oral baclofen since plasma concentrations are
higher and signs and symptoms of baclofen withdrawal may
Gail Delaney, MD, Associate Professor, Department of
occur. Possible prophylactic therapy of these infants in the ini-
Physical Medicine and Rehabilitation, University of Western
tial neonatal period may be warranted (Moran et al., 2004).
Ontario, works in the Spinal Cord Injury Program, Parkwood
Our patient’s infant was closely monitored and demonstrated
Hospital, St. Joseph’s Health Care.
no evidence of baclofen withdrawal or teratogenicity. Thepatient was encouraged to participate in her infant’s care and
Simon Levin, MD, FRCPC, Consultant Pediatric Neurologist,
establish breastfeeding early in the initial postpartum period.
Children’s Hospital, London Health Sciences Centre,Associate Professor, Department of Pediatrics and Clinical
Currently, no literature is available to suggest ITB is contraindi-
Neurosciences, Schulich School of Medicine and Dentistry,
cated with breastfeeding. Given that plasma levels are largely
undetectable, our patient chose to breastfeed her infant forthree-and-a-half months. No adverse effects were noted on
Sandrine De Ribaupierre, MD, Pediatric Neurosurgeon, London
multiple assessments, such as neurological or growth and devel-
Health Sciences Centre, Assistant Professor, Schulich School of
opmental issues. Additionally, the literature reports no adverse
Medicine and Dentistry, University of Western Ontario.
developmental effects in healthy infants born to patients withITB pumps (Dalton et al., 2008; Delhaas, 1992; Munoz & Marco,
Craig Campbell, MD, MSc, FRCPC, Pediatric Neurologist at
2000; Roberts et al., 2003). Our patient’s son is exceeding his
Children’s Hospital, London Health Sciences Centre, Assistant
developmental milestones at the age of 15 months, lending addi-
Professor, Department of Pediatrics, Clinical Neurological
tional support that ITB does not adversely affect development.
Sciences and Epidemiology, Schulich School of Medicine andDentistry, University of Western Ontario.
Comments or requests for further information may be
Our case lends support for the safety and efficacy of ITB dur-
directed via e-mail to firstname.lastname@example.org
ing the intrapartum period and the impression of lack of side
Albright, L. (1999). Plasma baclofen levels in children
Moran, L.R., Almeida, P.G., Worden, S., & Huttner, K.M.
receiving continuous intrathecal baclofen infusion. Journal of Child
(2004). Intrauterine baclofen exposure: A multidisciplinary approach.
Ashworth B. (1964). Preliminary trial of carisoprodol in
Munoz, C., & Marco, D. (2000). Pregnancy outcome in a
multiple sclerosis. Practitioner, 192,
woman exposed to continuous intrathecal baclofen infusion. The
Bhimani, R. (2008). Intrathecal baclofen therapy in adults and
Annals of Pharmacotherapy, 34,
guideline for clinical nursing care. Rehabilitation Nursing, 33
Penn, R.D., & Kroin, J.S. (1985). Continuous intrathecal
baclofen for severe spasticity. Lancet, 2
Dalton, C.M., Keenan, E., Jarrett, L., Buckley, L., & Stevenson,
Pereira, L. (2003). Obstetric management of the patient with
V. (2008). The safety of baclofen in pregnancy: Intrathecal therapy in
spinal cord injury. Obstetrical and Gynecological Survey, 58
multiple sclerosis. Multiple Sclerosis, 14,
Delhaas, E.M., & Verhagen, J. (1992). Pregnancy in a
Roberts, A.G., Graves, C.R., Konrad, P.E., Groomes, T.E.,
quadriplegic patient treated with continuous intrathecal baclofen
Pfister, A.A., Damian, M.M., et al. (2003). Intrathecal baclofen pump
infusion to manage her severe spasticity. Case report. Paraplegia,
implantation during pregnancy. Neurology, 61
Thomson Micromedex. (2008). MICROMEDEX® Healthcare
Engrand, J., Van de Perre, P., Vilain, G., & Benhamou, D.
. Retrieved from http://www.thomsonhc.com/hcs/librarian/
(2001). European Journal of Anaesthesiology, 18,
Medtronic. (2004). Synchromed II Programmable Infusion
System, Clinical Reference Guide
. Minneapolis, MN.
Volume 31, Issue 3, 2009 • Canadian Journal of Neuroscience Nursing
Author: Doni, Giovanni BattistaTitle: Aduersaria Musica GEditor: Massimo RedaelliSource: Florence, Biblioteca Marucelliana, MS A.291, f. <1r>-<26v> [-<f.1r>-] [G in marg.] Aduersaria MusicaPulsuum differentiae aliae sunt intrinsecae quae a uitula ui oriuntur ut celer tardus magnus paruus. Alie extrinsecae quae ab arteria et organis nascuntur ut siccus durus mollior et cetera. Pr
AÇÕES INDIVIDUAIS – ASSESSORIA JURÍDICA O SINAL-DF tem prestado assistência judicial nas seguintes causas individuais, entre outras: Atualização monetária sobre valores pagos com atraso na via administrativa Muitos servidores recebem valores relativos a períodos pretéritos. Tais valores devem ser atualizados monetariamente desde a data em que a vantagem deixou de ser paga. A j