Which types of data are needed to select the appropriate fetal diagnostic procedures?

ABSTRACT

Objective

This revised guideline provides updated information for the care of women with chronic viral infections who require intrauterine fetal diagnostic testing.

Target Population

Women with chronic viral infections who are pregnant or planning a pregnancy.

Options

Non-invasive screening tests for diagnosis: maternal serum placental analytes with or without nuchal translucency, sonography, maternal serum cell-free placental DNA; and intrauterine fetal diagnostic testing: amniocentesis, chorionic villus sampling, cordocentesis.

Outcomes

The recommendations in this guideline have the potential to decrease or eliminate morbidity and mortality in women with chronic viral infections and their infants, which is associated with significant health and economic outcomes.

Evidence

Published literature was retrieved through searches of PubMed, guidelines of national societies (Society of Obstetricians and Gynaecologists of Canada, American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, other international societies), and the Cochrane Library using appropriate controlled vocabulary (amniocentesis, chorionic villus sampling, cordocentesis, procedure pregnancy loss risk, viral vertical transmission, fetal and neonatal infection) and keywords (maternal infection or exposure, hepatitis B, hepatitis C, human immunodeficiency virus). Results were restricted to systematic reviews, randomized controlled trials or controlled clinical trials (if available), and observational case-control studies or case series from 2012 to 2019 published in English or French. Studies from 1966 to 2002 were previously reviewed in the SOGC guideline No. 123: Amniocentesis and Women with Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus, and those from 2002 to 2012 were previously reviewed in the SOGC guideline No. 309: Prenatal Invasive Procedures in Women With Hepatitis B, Hepatitis C, and/or Human Immunodeficiency Virus Infections. Updated literature searches were completed regularly through August 2019 and were incorporated into this guideline.

Validation Methods

The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations).

Intended Audience

The intended users are maternity care providers and women with chronic viral infections. This guideline provides information to educate and counsel these women, and to offer them reproductive options.

RECOMMENDATIONS (GRADE ratings in parentheses)

  • 1

    For women with a chronic infection with hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV), the use of non-invasive methods of fetal aneuploidy risk assessment is recommended, using screening tests with high sensitivity and low false-positive rates (maternal serum placental analytes with or without nuchal translucency, detailed sonography [dating crown-rump length, first- and second-trimester anatomic] and maternal serum cell-free placental DNA as first- or second-tier screening test) (strong, moderate).

  • 2

    When counselling pregnant women with a chronic infection that can pose a risk of perinatal morbidity regarding intrauterine fetal diagnostic genetic and/or infectious testing:

    • The pregnancy loss rate (spontaneous loss rate and rate due to the procedure) discussed should be based on the gestational age at the time of the procedure (strong, high).

    • The first trimester (when chorionic villus sampling is performed) has an estimated spontaneous pregnancy loss rate of 1.40% (based on a population cohort of maternal age >36 years with normal first-trimester sonographic screening); the second trimester (when amniocentesis is performed) has an estimated spontaneous pregnancy loss rate of 0.65% (based on a population cohort of maternal age >36 years with normal second-trimester sonographic screening) (strong, high).

    • The estimated risk of pregnancy loss due to amniocentesis is 0.35% to 1.00%, based on systematic reviews or meta-analyses, cohort studies with control groups, and randomized controlled trials; the risk varies depending on provider expertise (strong, high).

  • 3

    When performing sonography-guided amniocentesis for women with a chronic hepatitis B, hepatitis C, and/or HIV infection, every effort should be made to avoid the amniocentesis needle going through the placenta or within 1 to 2 cm of the implantation placental edge (strong, moderate).

  • Hepatitis B

  • 4

    Hepatitis B virus DNA load should be evaluated in women with positive hepatitis B surface antigen status who require intrauterine fetal diagnostic testing. A viral DNA load >200 000 IU/mL or >106 copies/mL and positive hepatitis B e antigen status increase the risk of vertical transmission (strong, moderate).

  • 5

    In women with chronic hepatitis B infection and a significant viral load (>200 000 IU/mL or >106 copies/mL), maternal antiviral therapy should be considered in order to decrease the vertical transmission risk. The first-line antenatal antiretroviral agent tenofovir is recommended (strong, moderate).

  • Hepatitis C

  • 6

    In women with chronic hepatitis C infection, amniocentesis is recommended over chorionic villus sampling due to the limited data available on chorionic villus sampling (conditional, low).

  • 7

    Amniocentesis in women with a chronic hepatitis C infection does not appear to significantly increase the risk of vertical transmission of the virus; however, there is limited published cohort data, and this information should be shared with the patient during the informed consent process (conditional, low).

  • HIV

  • 8

    Pregnant women with HIV have reported pregnancy loss rates after amniocentesis of 2.6% to 22% (although only small cohorts have been reported) and vertical transmission rates of 0% to 2.3%. Data evaluating the clinical use of amniocentesis among women with HIV is increasing but still limited, and this information should be shared with women during the informed consent process (conditional, low).

  • 9

    Amniocentesis in women with HIV who are treated with combination antiretroviral therapy appears to pose no increased risk of vertical transmission of HIV, especially if the antiviral therapy reduces the maternal viral load to undetectable levels (strong, high).

Keywords

  • amniocentesis
  • chorionic villus sampling
  • maternal infection
  • hepatitis B
  • hepatitis C
  • HIV

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REFERENCES

    • Khan AM
    • Morris SK
    • Bhutta ZA

    Neonatal and perinatal infections.

    Pediatr Clin North Am. 2017; 64: 785-798
    • Beigi RH

    Emerging infectious diseases in pregnancy.

    Obstet Gynecol. 2017; 129: 896-906
    • Vygivska LA
    • Tuchkina IO
    • Kalnytska VB

    The impact of emergent infections on the fetal state.

    Wiad Lek. 2017; 70: 731-736
    • Racicot K
    • Mor G

    Risks associated with viral infections during pregnancy.

    J Clin Invest. 2017; 127: 1591-1599
    • Rac MW
    • Sheffield JS

    Prevention and management of viral hepatitis in pregnancy.

    Obstet Gynecol Clin North Am. 2014; 41: 573-592
    • Castillo E
    • Murphy K
    • van Schalkwyk J

    No. 342-Hepatitis B and pregnancy.

    J Obstet Gynaecol Can. 2017; 39: 181-190
    • Dionne-Odom J
    • Mbah R
    • Rembert NJ
    • et al.

    Hepatitis B, HIV, and syphilis seroprevalence in pregnant women and blood donors in Cameroon.

    Infect Dis Obstet Gynecol. 2016; 20164359401
    • Owens DK
    • Davidson KW
    • et al.
    • US Preventive Services Task Force

    Screening for hepatitis B virus infection in pregnant women: US Preventive Services Task Force reaffirmation recommendation statement.

    JAMA. 2019; 322: 349-354
    • Jin J

    Screening for hepatitis B in pregnant women.

    JAMA. 2019; 322: 376
    • Hughes BL
    • Page CM
    • et al.
    • Society for Maternal-Fetal Medicine

    Hepatitis C in pregnancy: screening, treatment, and management.

    Am J Obstet Gynecol. 2017; 217: B2-B12
    • Dibba P
    • Cholankeril R
    • Li AA
    • et al.

    Hepatitis C in pregnancy.

    Diseases. 2018; 6: 31
    • Tovo PA
    • Calitri C
    • Scolfaro C
    • et al.

    Vertically acquired hepatitis C virus infection: correlates of transmission and disease progression.

    World J Gastroenterol. 2016; 22: 1382-1392
    • Money D
    • Tulloch K
    • Boucoiran I
    • et al.

    Guidelines for the care of pregnant women living with HIV and interventions to reduce perinatal transmission: executive summary.

    J Obstet Gynaecol Can. 2014; 36: 721-734
    • Committee on Obstetric Practice
    • HIV Expert Work Group

    ACOG committee opinion no. 752: prenatal and perinatal human immunodeficiency virus testing.

    Obstet Gynecol. 2018; 132: e138-ee42
    • Owens DK
    • Davidson KW
    • et al.
    • US Preventive Services Task Force

    Screening for HIV infection: US Preventive Services Task Force recommendation statement.

    JAMA. 2019; 321: 2326-2336
    • Cryer AM
    • Imperial JC

    Hepatitis B in pregnant women and their infants.

    Clin Liver Dis. 2019; 23: 451-462
    • Ma K
    • Berger D
    • Reau N

    Liver diseases during pregnancy.

    Clin Liver Dis. 2019; 23: 345-361
    • Garcia-Romero CS
    • Guzman C
    • Cervantes A
    • et al.

    Liver disease in pregnancy: medical aspects and their implications for mother and child.

    Ann Hepatol. 2019; 18: 553-562
    • Arora A
    • Kumar A
    • Anand AC
    • et al.

    Indian National Association for the Study of the Liver-Federation of Obstetric and Gynaecological Societies of India position statement on management of liver diseases in pregnancy.

    J Clin Exp Hepatol. 2019; 9: 383-406
    • Arora N
    • Sadovsky Y
    • Dermody TS
    • et al.

    Microbial vertical transmission during human pregnancy.

    Cell Host Microbe. 2017; 21: 561-567
    • Racicot K
    • Aldo P
    • El-Guindy A
    • et al.

    Cutting edge: fetal/placental type I IFN can affect maternal survival and fetal viral load during viral infection.

    J Immunol. 2017; 198: 3029-3032
    • Giorlandino C
    • Gambuzza G
    • D'Alessio P
    • et al.

    Blood contamination of amniotic fluid after amniocentesis in relation to placental location.

    Prenat Diagn. 1996; 16: 180-182
    • Hyun MH
    • Lee YS
    • Kim JH
    • et al.

    Systematic review with meta-analysis: the efficacy and safety of tenofovir to prevent mother-to-child transmission of hepatitis B virus.

    Aliment Pharmacol Ther. 2017; 45: 1493-1505
    • Cheung KW
    • Seto MTY
    • Lao TT

    Prevention of perinatal hepatitis B virus transmission.

    Arch Gynecol Obstet. 2019; 300: 251-259
    • Chappell CA
    • Hillier SL
    • Crowe D
    • et al.

    Hepatitis C virus screening among children exposed during pregnancy.

    Pediatrics. 2018; 141e20173273
    • Rogan SC
    • Beigi RH

    Treatment of viral infections during pregnancy.

    Clin Perinatol. 2019; 46: 235-256
    • Orekondy N
    • Cafardi J
    • Kushner T
    • et al.

    HCV in women and pregnancy.

    Hepatology. 2019; 70: 1836-1840
    • Freriksen JJM
    • van Seyen M
    • Judd A
    • et al.

    Review article: direct-acting antivirals for the treatment of HCV during pregnancy and lactation - implications for maternal dosing, foetal exposure, and safety for mother and child.

    Aliment Pharmacol Ther. 2019; 50: 738-750

Article Info

Publication History

No. 409, December 2020 (Replaces No. 309, July 2014)

Footnotes

This document reflects emerging clinical and scientific advances as of the publication date and is subject to change. The information is not meant to dictate an exclusive course of treatment or procedure. Institutions are free to amend the recommendations. The SOGC suggests, however, that they adequately document any such amendments.

Informed consent: Everyone has the right and responsibility to make informed decisions about their care together with their health care providers. In order to facilitate this, the SOGC recommends that health care providers provide patients with information and support that is evidence-based, culturally appropriate, and personalized.

Language and inclusivity: This document uses gendered language in order to facilitate plain language writing but is meant to be inclusive of all individuals, including those who do not identify as a woman/female. The SOGC recognizes and respects the rights of all people for whom the information in this document may apply, including but not limited to transgender, non-binary, and intersex people. The SOGC encourages healthcare providers to engage in respectful conversation with their patients about their gender identity and preferred gender pronouns and to apply these guidelines in a way that is sensitive to each person's needs.

Copyright: The contents of this document, in whole or in part, cannot be reproduced in any form without prior written permission of the publisher of the Journal of Obstetrics and Gynaecology Canada.

Identification

DOI: https://doi.org/10.1016/j.jogc.2020.09.007

Copyright

© 2020 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

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