<html> <head> <meta charset="UTF-8"/> <meta name="tikaGenerated" content="true"/> <meta name="date" content="2015-07-10T00:41:35Z"/> <meta name="creator" content="csteen01"/> <meta name="xmp:CreatorTool" content="Adobe Acrobat Pro 11.0.6"/> <meta name="meta:author" content="csteen01"/> <meta name="meta:creation-date" content="2015-07-10T00:41:35Z"/> <meta name="created" content="Fri Jul 10 10:11:35 ACST 2015"/> <meta name="dc:creator" content="csteen01"/> <meta name="xmpTPg:NPages" content="9"/> <meta name="Creation-Date" content="2015-07-10T00:41:35Z"/> <meta name="dcterms:created" content="2015-07-10T00:41:35Z"/> <meta name="Last-Modified" content="2015-07-10T00:41:35Z"/> <meta name="dcterms:modified" content="2015-07-10T00:41:35Z"/> <meta name="Last-Save-Date" content="2015-07-10T00:41:35Z"/> <meta name="meta:save-date" content="2015-07-10T00:41:35Z"/> <meta name="Author" content="csteen01"/> <meta name="producer" content="Adobe Acrobat Pro 11.0.6"/> <meta name="modified" content="2015-07-10T00:41:35Z"/> <meta name="Content-Type" content="application/pdf"/> </head> <body> <pre> Version control and change history Version Date from Date to Amendment 1.0 03 Mar 04 21 Sept 10 Original version 2.0 21 Sept 10 20 May 13 Reviewed 3.0 20 May 13 24 Jun 15 Reviewed 4.0 24 Jun 15 Current Department for Health and Ageing, Government of South Australia. All rights reserved. Clinical Guideline Toxoplasmosis in pregnancy Policy developed by: SA Maternal & Neonatal Clinical Network Approved SA Health Safety & Quality Strategic Governance Committee on: 24 June 2015 Next review due: 24 June 2018 Summary Guideline for the management of the pregnant woman with Toxoplasmosis Keywords toxoplasmosis, parasite, tosoplasma gondii, seropositive, meat, cats faeces, vegetables, fruits, standard precautions, congenital, chorioretinitis, hydrocephalus, intracranial calcification, raw meat, soil, igm, iga, igg, polymerase chain reaction, pcr, amniotic, infection, ultrasound, amniocentesis, rovamycine, spiramycin, atovaquone, azithromycin, ophthalmological, parasites, autopsy, ultrasound, cerebrospinal fluid, chorioretinitis, retinal scarring, intracranial calfication, hydrosephalus, hepatosplenomegaly, pheumonia, thrombocytopenia, lymphadenopathy, myocarditis, neonate, Toxoplasmosis in pregnancy clinical guideline Policy history Is this a new policy? N Does this policy amend or update an existing policy? Y v3.0 Does this policy replace an existing policy? Y If so, which policies? Applies to All Health Networks CALHN, SALHN, NALHN, CHSALHN, WCHN, SAAS Staff impact All Clinical, Medical, Nursing, Allied Health, Emergency, Dental, Mental Health, Pathology PDS reference CG126 Policy South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy Department of Health, Government of South Australia. All rights reserved. ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 1 of 8 Page 1 of 8 Note This guideline provides advice of a general nature. This statewide guideline has been prepared to promote and facilitate standardisation and consistency of practice, using a multidisciplinary approach. The guideline is based on a review of published evidence and expert opinion. Information in this statewide guideline is current at the time of publication. SA Health does not accept responsibility for the quality or accuracy of material on websites linked from this site and does not sponsor, approve or endorse materials on such links. Health practitioners in the South Australian public health sector are expected to review specific details of each patient and professionally assess the applicability of the relevant guideline to that clinical situation. If for good clinical reasons, a decision is made to depart from the guideline, the responsible clinician must document in the patient s medical record, the decision made, by whom, and detailed reasons for the departure from the guideline. This statewide guideline does not address all the elements of clinical practice and assumes that the individual clinicians are responsible for discussing care with consumers in an environment that is culturally appropriate and which enables respectful confidential discussion. This includes: The use of interpreter services where necessary, Advising consumers of their choice and ensuring informed consent is obtained, Providing care within scope of practice, meeting all legislative requirements and maintaining standards of professional conduct, and Documenting all care in accordance with mandatory and local requirements Explanation of the aboriginal artwork: The aboriginal artwork used symbolises the connection to country and the circle shape shows the strong relationships amongst families and the aboriginal culture. The horse shoe shape design shown prior to the generic statement symbolises a woman and those enclosing a smaller horse shoe shape depicts a pregnant women. The smaller horse shoe shape in this instance represents the unborn child. The artwork shown before the specific statements within the document symbolises a footprint and demonstrates the need to move forward together in unison. Australian Aboriginal Culture is the oldest living culture in the world yet we experience the worst health outcomes in comparison. Our Aboriginal women are 2-5 times more likely to die in childbirth and our babies are 2-3 times more likely to be low birth weight. Despite these unacceptable statistics the birth of an Aboriginal baby is an important Cultural event and diverse protocols during the birthing journey may apply. South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 2 of 8 Toxoplasmosis ? Toxoplasmosis is caused by a parasite, Toxoplasma gondii. It is usually asymptomatic or may have mild non-specific symptoms (e.g. malaise, fever, and lymphadenopathy) ? Toxoplasma remains latent for life, with clinical reactivation confined to severely immunosuppressed individuals 1 ? Infants of women who are seropositive before pregnancy are not at risk Route of transmission ? Toxoplasmosis is acquired through ? Eating raw or undercooked meat ? Not washing hands thoroughly after handling raw meat or gardening, or contact with cats faeces (directly or indirectly through the soil, or possibly contaminated raw vegetables or fruits) 3 ? Direct contact with cats is rarely a source of transmission 1 Infection precautions ? Standard precautions Literature review ? In Australia, primary infection with toxoplasmosis during pregnancy is rare 1 The risk of maternal-fetal transmission and abnormalities related to congenital toxoplasmosis infection is related to the gestation at maternal seroconversion ? 13 week s gestation: ? 5 - 15 % risk of maternal-fetal transmission ? 60 - 80 % chance of abnormalities if infected Second trimester: ? 25 - 40 % risk of maternal-fetal transmission ? 15 - 25 % chance of abnormalities if infected Third trimester: ? 30 - 75 % risk of maternal-fetal transmission 36 week s gestation: ? 72 % risk of maternal-fetal transmission ? 2 - 10 % chance of abnormalities if infected 5,7 ? Abnormalities following severe congenital toxoplasmosis are more common amongst babies of women who seroconverted early in their pregnancy 5,6 ? Abnormalities related to congenital toxoplasmosis are: ? Chorioretinitis ? Hydrocephalus ? Intracranial calcification ? Mental retardation South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 3 of 8 Precautions to avoid maternal exposure to toxoplasmosis Encourage all pregnant women to: ? Avoid raw / undercooked meat ? Avoid contamination of chopping boards, etc. with raw meat ? Wash hands after disposal of cat litter, gardening or handling raw meat ? Peel or wash raw fruit and vegetables thoroughly to remove contaminating soil 1 (Gilbert 2002) Maternal exposure ? Women who are pregnant in South Australia are not routinely screened for the presence of IgG antibodies or toxoplasma-specific IgM antibodies ? Consider serology (IgG and IgM antibodies to toxoplasma gondii) for women who are pregnant with symptoms of acute toxoplasmosis (e.g. malaise, fever, lymphadenopathy) IgG and IgM negative ? Indicates no past infection ? Educate regarding precautions to avoid infection with toxoplasmosis ? Repeat if symptomatic IgG positive IgM negative ? Indicates past infection IgG and IgM positive ? Indicates possible recent infection ? IgM can remain positive for months or years; IgA, rising IgG level and / or low IgG avidity are more specific for recent infection ? Repeat serology for IgM, IgA, and / or IgG titre and avidity ? A repeat high positive IgM, positive IgA and low IgG avidity is consistent with recent toxoplasmosis Maternal management Following confirmation of recent maternal toxoplasmosis Investigations ? Ultrasound to detect abnormalities ? Amniocentesis for polymerase chain reaction (PCR) and / or culture at 18 - 20 weeks gestation or if ? 4 weeks after maternal infection ? PCR on amniotic fluid has a high sensitivity and specificity for the diagnosis of fetal infection 4 ? If the ultrasound and amniocentesis are negative, consider pharmacological treatment as below if maternal infection is fairly certain Note: A Cochrane Review has shown there have been no randomised trials of treatment for toxoplasmosis in pregnancy 2 . Treatment decisions should bear this in mind. Management algorithms are available in Palasanthiran P, et al. 7 and Montoya J G and Remington JS. 11 South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 4 of 8 Infection in first 12 weeks gestation ? Administer spiramycin [Rovamycine ]. Not in stock in South Australia ? May be able to obtain supply from Monash Medical Centre Pharmacy or otherwise within a week from overseas via LINK Pharmaceuticals Bridgepoint Mosman, NSW. 2088. Telephone: (02) 9960 0150 ? See Drug Interactions listed in Neonatal Management section ? Mild to moderate infections: 6,000,000 to 9,000,000 int. units (4 - 6 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses ? Severe infections: 12,000,000 to 15,000,000 int. units (8 - 10 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses ? Counsel woman / partner regarding termination if amniocentesis PCR positive Infection from 13 to 27 weeks ? Administer spiramycin [Rovamycine ] (sulfadiazine and pyrimethamine are no longer available) ? Mild to moderate infections: 6,000,000 to 9,000,000 int. units (4 - 6 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses ? Severe infections: 12,000,000 to 15,000,000 int. units (8 - 10 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses ? If there is delay in obtaining spiramycin, administer Atovaquone 750 mg twice daily (or 1,500 mg once daily if necessary) with food for 21 days ? Alternatively, Azithromycin 500 mg daily for 3 days repeated weekly for 4 weeks may be tried. Its efficacy has not been proven but it has an IC50 of 1.2 mg / mL and concentrates in tissues, especially the placenta 2 ? Counsel woman / partner regarding termination if ultrasound abnormal Infection from 28 to 42 weeks ? Administer spiramycin [Rovamycine ] ? Mild to moderate infections: 6,000,000 to 9,000,000 int. units (4 - 6 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses ? Severe infections: 12,000,000 to 15,000,000 int. units (8 - 10 capsules of spiramycin [Rovamycine ] "500" per day) in 2 divided doses OR if unavailable: ? Administer Atovaquone 750 mg twice daily (or 1,500 mg once daily if necessary) with food for 21 days ? Alternatively, Azithromycin 500 mg daily for 3 days repeated weekly for 4 weeks may be tried Intrapartum care ? Paediatrician at delivery ? Following delivery, newborn assessment should include physical examination for evidence of congenital toxoplasmosis (including ophthalmological examination and cerebral ultrasound) ? Placenta for histology / PCR ? May direct room-in with mother following initial assessment in nursery ? Use standard precautions (Parasites may be excreted in urine and other body fluids. A case of toxoplasmosis acquired during performance of an autopsy has been described) 8 (Neu 1967) South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 5 of 8 Postnatal follow up ? Involvement of a specialist infectious diseases physician may be helpful Neonatal management Investigations ? Ophthalmological assessment and cerebral ultrasound ? Infant whole blood for PCR, and serology for toxoplasma-specific IgM and / or IgA, persistent IgG ? Cerebrospinal fluid for PCR Asymptomatic congenital toxoplasmosis ? The majority of infected babies will be asymptomatic ? Includes babies with positive serology and / or IgG that persists for more than 6 months Symptomatic congenital toxoplasmosis ? A small minority of babies will have symptomatic congenital toxoplasmosis (IgM or PCR positive with an IgG titre significantly greater than mothers) e.g: ? Chorioretinitis / retinal scarring ? Intracranial calcification ? Hydrocephalus ? Hepatosplenomegaly ? Pneumonia ? Thrombocytopenia ? Lymphadenopathy ? Myocarditis and IgM positive and / or abnormal placenta and / or cerebrospinal fluid abnormality (PCR positive) Drug treatment ? Administer spiramycin oral syrup: available in 75 000 units / mL (25 mg / mL) ? Neonate: Dosage by body weight; usual dosage 150,000 int. units / kg (50 mg / kg) twice daily Drug Interactions: ? Substrate of CYP3A4 (major) ? CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of spiramycin. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins ? CYP3A4 inhibitors: May increase the levels/effects of spiramycin. Example inhibitors include azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil ? Levodopa / carbidopa: Spiramycin has been reported to decrease carbidopa absorption and decrease levodopa concentrations South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 6 of 8 Follow up ? Continue above drug treatment for the first 12 months ? Repeat IgG at 6 months ? Regular paediatric / infectious diseases review is recommended South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 7 of 8 References 1. Gilbert GL. Infections in pregnant women. MJA 2002; 176: 229-236. 2. Peyron F,WallonM, Liou C, Garner P. Treatments for toxoplasmosis in pregnancy. Cochrane Database of Systematic Reviews 1999, Issue 3. Art. No.: CD001684. DOI: 10.1002/14651858.CD001684 (Level I). Available from URL: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001684/pdf_fs.h tml 3. Di Mario S, Basevi V, Gagliotti C, Spettoli D, Gori G, D Amico R, Magrini N. Prenatal education for congenital toxoplasmosis. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD006171. DOI:10.1002/14651858.CD006171.pub2. Available from URL: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006171/pdf_fs.h tml 4. Karunajeewa H, Siebert D, Hammond R, Garland S, Kelly H. Seroprevalence of varicella zoster virus, parvovirus B19 and Toxoplasma gondii in a Melbourne obstetric population: implications for management. ANZJOG 2001; 41: 23-28 (Level IV). 5. Dunn D, Wallon M, Peyron F, Petersen E, Peckham C, Gilbert R. Mother-to-child transmission of toxoplasmosis: risk estimates for clinical counselling. The Lancet 1999; 353: 1829-33 (Level IV). 6. Langford KS. Infectious disease and pregnancy. Current Obstet Gynaecol 2002; 12: 125-30. 7. Palasanthiran P, Starr M, Jones C, Giles M, editors. Management of perinatal infections. Sydney: Australasian Society for Infectious Diseases (ASID) 2014. Available from: URL: http://www.asid.net.au/resources/clinical-guidelines 8. Neu HC. Toxoplasmosis transmitted at autopsy. JAMA 1967; 202:844-5 (Level IV). 9. Peyron F, Wallon M. Options for the pharmacotherapy of toxoplasmosis during pregnancy. Expert Opinion in Pharmacotherapy. 2001; 2(8):1269-1274. 10. British National Formulary for Children (BNFC). Drugs for toxoplasmosis Spiramycin. London: The Royal Pharmaceutical Society of Great Britain; 2009. 11. Montoya J G and Remington JS. Management of Toxoplasma gondii Infection during Pregnancy. Clin Infect Dis. 2008;47:554 66. Useful web sites: Organisation of teratology information specialists Toxoplasmosis and pregnancy. Available from URL: http://www.otispregnancy.org/pdf/toxoplasmosis.pdf South Australian Department of Health. You ve got what Toxoplasma infection. Available from URL: www.sahealth.sa.gov.au/youvegotwhat in the A to Z index South Australian Perinatal Practice Guidelines toxoplasmosis in pregnancy ISBN number: 978-1-74243-752-1 Endorsed by: South Australian Maternal & Neonatal Clinical Network Last Revised: 30/06/15 Contact: South Australian Perinatal Practice Guidelines Workgroup at: cywhs.perinatalprotocol@health.sa.gov.au Page 8 of 8 Version control and change history PDS reference: OCE use only Version Date from Date to Amendment 1.0 03 Mar 04 21 Sept 10 Original version 2.0 21 Sept 10 20 May 13 Reviewed 3.0 20 May 13 24 Jun 15 Reviewed 4.0 24 Jun 15 Current Abbreviations e.g. For example et al And others IgG Immunoglobulin G IgA Immunoglobulin A IgM Immunoglobulin M mg Milligram/s mL Millilitre/s PCR Polymerase chain reaction Toxoplasmosis in pregnancy_cover_July2015 Clinical Guideline Toxoplasmosis in pregnancy Policy developed by: SA Maternal & Neonatal Clinical Network Approved SA Health Safety & Quality Strategic Governance Committee on: 24 June 2015 Next review due: 24 June 2018 toxoplasmosis in pregnancy_policy_July2015 </pre> </body> </html>