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Guideline Summary
Guideline Title
Immunization in pregnancy.
Bibliographic Source(s)
Gruslin A, Steben M, Halperin S, Money DM, Yudin MH. Immunization in pregnancy. J Obstet Gynaecol Can. 2009 Nov;31(11):1085-92. [27 references]
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Gruslin A, Steben M, Halperin S, Money DM, Yudin MH, Boucher M, Cormier B, Ogilvie G, Paquet C, Steenbeek A, Van Eyk N, van Schalkwyk J, Wong T. Immunization in pregnancy. J Obstet Gynaecol Can 2008 Dec;30(12):1149-54. [17 references]

Scope

Disease/Condition(s)
  • Vaccine-preventable illnesses, including influenza and H1N1 infection
  • Pregnancy
Guideline Category
Assessment of Therapeutic Effectiveness
Counseling
Prevention
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Intended Users
Advanced Practice Nurses
Health Care Providers
Nurses
Patients
Physician Assistants
Physicians
Guideline Objective(s)

To review the evidence and provide recommendations on immunization in pregnancy

Target Population

Women who are considering pregnancy, already pregnant, or breastfeeding

Interventions and Practices Considered
  1. Evaluate women of childbearing age for pregnancy before immunizing.
  2. Obtain a relevant immunization history of all women accessing prenatal care.
  3. Recommend vaccination strategies during pregnancy and breastfeeding.
  4. Counsel women on risks and benefits of vaccines.
  5. Treat suspected or documented H1N1 infection with oseltamivir.
Major Outcomes Considered
  • Effectiveness of immunization
  • Side effects of vaccines
  • Risks and benefits of vaccines for mother and fetus

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The Medline and Cochrane databases were searched for articles published up to June 2008 on the topic of immunization in pregnancy.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly designed randomized controlled trial

II-1: Evidence from well-designed controlled trials without randomization

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

*Adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The evidence obtained was reviewed and evaluated by the Infectious Diseases Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) under the leadership of the principal authors, and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care.

Rating Scheme for the Strength of the Recommendations

Classification of Recommendations

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

†Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

This clinical practice guideline has been reviewed by the Infectious Diseases Committee and reviewed and approved by the Executive and Council of the Society of Obstetricians and Gynaecologists of Canada.

Recommendations

Major Recommendations

The quality of evidence (I–III) and the classification of recommendations (A–E, L) are defined at the end of the "Major Recommendations" field.

Introduction

  1. All women of childbearing age should be evaluated for the possibility of pregnancy before immunization. (III-A)
  2. Health care providers should obtain a relevant immunization history from all women accessing prenatal care. (III-A)

Review of Specific Vaccine Categories

Live and Live-attenuated Vaccines

See Table 2 in the original guideline document for detailed indications for vaccine use in pregnancy.

Benefits versus Risks of Live-attenuated Vaccines during Pregnancy

  1. In general, live and/or live-attenuated virus vaccines should not be administered during pregnancy, as there is a, largely theoretical, risk to the fetus. (II-3B)
  2. Women who have inadvertently received immunization with live or live-attenuated vaccines during pregnancy should not be counselled to terminate the pregnancy because of a teratogenic risk. (II-2A)
  3. Non-pregnant women immunized with a live or live-attenuated vaccine should be counselled to delay pregnancy for at least four weeks. (III-B)

Inactivated Viral Vaccines, Bacterial Vaccines, and Toxoids

  1. Inactivated viral vaccines, bacterial vaccines, and toxoids can be used safely in pregnancy. (II-1A)
  2. Women who are breastfeeding can still be immunized (passive-active immunization, live or killed vaccines). (II-1A)

H1N1 in Pregnancy

  1. Pregnant women should be offered the influenza vaccine (including H1N1 vaccine, when it is available) when they are pregnant during the influenza season. (II-1A)
  2. Pregnant women with suspected or documented H1N1 infection should be treated with oseltamivir (Tamiflu, 75 milligrams twice daily for 5 days) within 48 hours of onset of symptoms. (III-B)

Conclusion

The development of new vaccines and the accumulating information about vaccine safety ensure that health care providers can provide immunizations and/or advice about immunization for their pregnant patients. This is most important in disease prevention, and obstetrician-gynaecologists must play an active role in vaccine administration. Furthermore, it is imperative that more research efforts be focused in the area of immunization in pregnancy.

Definitions:

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly designed randomized controlled trial

II-1: Evidence from well-designed controlled trials without randomization

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Classification of Recommendations

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

*Adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.

†Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Implementation of the recommendations in this guideline should result in more appropriate immunization of pregnant and breastfeeding women, decreased risk of contraindicated immunization, and better disease prevention.

Potential Harms

Side-effects of Vaccines

Vaccines may cause various side effects, which should not all be interpreted as contraindications. Side effects can be divided in five categories: (1) immediate/early, (2) local, (3) systemic, (4) allergic, and (5) long-term.

  1. Immediate/early effects include fainting and vasovagal reactions. These are differentiated from anaphylactic shock (see below). Patients who have received the vaccine should be kept in the waiting room for observation for 15 to 30 minutes.
  2. Local effects are mild and are the most common. They include soreness, erythema, and swelling.
  3. Systemic effects are less common and include malaise and fever.
  4. Mild allergic reactions can also occur. In general, these will be in reaction to exposure to avian proteins (eggs, such as in yellow fever vaccine and influenza vaccine) or to traces of neomycin/streptomycin (measles/mumps/rubella [MMR]). Anaphylactic reactions are exceedingly rare. They should be recognized immediately and treated following local protocols with injection of subcutaneous (sc) epinephrine (1:1000).
  5. Guillain-Barré syndrome can occur but usually at rates lower than that seen for spontaneous disease (there being a temporal association but not always a causal association).

See Table 2 in the original guideline document for more details on fetal risks of vaccines.

Contraindications

Contraindications

In general, live and/or live-attenuated virus vaccines are contraindicated during pregnancy, as there is a primarily theoretical risk of infection to the fetus. The following vaccines are listed as contraindicated in Table 2 of the original guideline document with these comments:

  • Measles - No known fetal effects, but live vaccine-theoretical risk with increased risk of preterm labour, small for gestational age, and low birthweight
  • Mumps - No known fetal effects, but live vaccine-theoretical risk with increased risk of preterm labour, small for gestational age, and low birthweight
  • Poliomyelitis (oral polio vaccine: Sabin) - Use inactivated polio vaccine (Poliomyelitis: Salk)
  • Rubella - No known fetal effects, but live vaccine-theoretical risk with increased risk of preterm labour, small for gestational age, and low birthweight
  • Vaccinia - Has been reported to cause fetal infection
  • Varicella - Fetal effects, if any, unknown. Not reason for termination. Varicella zoster immunoglobulin to be considered if pregnant woman exposed to virus. Antiviral if diseased should immunize susceptible women postpartum
  • Yellow Fever - No data on fetal safety, although fetuses exposed have not demonstrated complications. Not a reason for pregnancy termination. If travel to high-risk endemic area unavoidable, suggest vaccination

See Table 2 for more details on live vaccines and on non-live vaccines that are considered but lack appropriate safety data.

Qualifying Statements

Qualifying Statements

This document reflects emerging clinical and scientific advances on the date issued and are subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the Society of Obstetricians and Gynaecologists of Canada (SOGC).

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Foreign Language Translations
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Gruslin A, Steben M, Halperin S, Money DM, Yudin MH. Immunization in pregnancy. J Obstet Gynaecol Can. 2009 Nov;31(11):1085-92. [27 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2008 Dec (revised 2009 Nov)
Guideline Developer(s)
Society of Obstetricians and Gynaecologists of Canada - Medical Specialty Society
Source(s) of Funding

Society of Obstetricians and Gynaecologists of Canada

Guideline Committee

Infectious Diseases Committee

Composition of Group That Authored the Guideline

Principal Authors: Andrée Gruslin, MD, Ottawa ON; Marc Steben, MD, Montreal QC; Scott Halperin, MD, Halifax NS; Deborah M. Money, MD, Vancouver BC; Mark H. Yudin, MD, Toronto ON

Committee Members: Mark H. Yudin, MD (Chair), Toronto ON; Marc Boucher, MD, Montreal QC; Beatrice Cormier, MD, Montreal QC; Andrée Gruslin, MD, Ottawa ON; Deborah M. Money, MD, Vancouver BC; Gina Ogilvie, MD, Vancouver BC; Caroline Paquet, RM, Trois-Rivières QC; Audrey Steenbeek, RN, Halifax NS; Nancy Van Eyk, MD, Halifax NS; Julie van Schalkwyk, MD, Vancouver BC; Thomas Wong, MD, Ottawa ON

Special Contributor: Noni MacDonald, MD, Halifax NS

Financial Disclosures/Conflicts of Interest

Disclosure statements have been received from all members of the committee.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Gruslin A, Steben M, Halperin S, Money DM, Yudin MH, Boucher M, Cormier B, Ogilvie G, Paquet C, Steenbeek A, Van Eyk N, van Schalkwyk J, Wong T. Immunization in pregnancy. J Obstet Gynaecol Can 2008 Dec;30(12):1149-54. [17 references]

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Society of Obstetricians and Gynaecologists of Canada (SOGC) Web site External Web Site Policy. Also available in French from the SOGC Web site External Web Site Policy.

Print copies: Available from the Society of Obstetricians and Gynaecologists of Canada, La société des obstétriciens et gynécologues du Canada (SOGC) 780 Echo Drive Ottawa, ON K1S 5R7 (Canada); Phone: 1-800-561-2416

Availability of Companion Documents

None available

Patient Resources

Patient resources are available in English and French from the Society of Obstetricians and Gynaecologists of Canada Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on April 8, 2010. The information was verified by the guideline developer on April 29, 2010. This summary was updated by ECRI Institute on July 15, 2011 following the U.S. Food and Drug Administration advisory on Tamiflu (oseltamivir phosphate).

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

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