Vaccines for women to prevent neonatal tetanus

[Intervention Review]
Vaccines for women to prevent neonatal tetanus

Vittorio Demicheli1, Antonella Barale2, Alessandro Rivetti3

1Health Councillorship - Servizio Regionale di Riferimento per l'Epidemiologia, SSEpi-SeREMI - Cochrane Vaccines Field, Regione Piemonte - Azienda Sanitaria Locale ASL AL, Torino, Italy. 2Servizio Sovrazonale di Epidemiologia , Alessandria, Italy. 3Servizio Regionale di Riferimento per l'Epidemiologia, SSEpi-SeREMI - Cochrane Vaccines Field, Azienda Sanitaria Locale ASL AL, Alessandria, Italy

Contact address: Vittorio Demicheli, Health Councillorship - Servizio Regionale di Riferimento per l'Epidemiologia, SSEpi-SeREMI - Cochrane Vaccines Field, Regione Piemonte - Azienda Sanitaria Locale ASL AL, C.so Regina Margherita 153 bis, Torino, Piemonte, 10122, Italy. Vittorio.DeMicheli@regione.piemonte.it. vittorio.demicheli@regione.piemonte.it. (Editorial group: Cochrane Pregnancy and Childbirth Group.)

Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD002959.pub2
This version first published online: 19 October 2005 in Issue 4, 2005. Last assessed as up-to-date: 30 June 2007. (Help document - Dates and Statuses explained).

This record should be cited as: Demicheli V, Barale A, Rivetti A. Vaccines for women to prevent neonatal tetanus. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD002959. DOI: 10.1002/14651858.CD002959.pub2.

Abstract

Background
Tetanus is an acute, often fatal, disease caused by an exotoxin produced by Clostridium tetani. It occurs in newborn infants born to mothers who do not have sufficient circulating antibodies to protect the infant passively, by transplacental transfer. Prevention may be possible by the vaccination of pregnant or non-pregnant women, or both, with tetanus toxoid, and the provision of clean delivery services. Tetanus toxoid consists of a formaldehyde-treated toxin which stimulates the production of antitoxin.

Objectives
To assess the effectiveness of tetanus toxoid, administered to women of childbearing age or pregnant women, to prevent cases of, and deaths from, neonatal tetanus.

Search strategy
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2007), The Cochrane Library (2007, Issue 2), MEDLINE (1966 to June 2007), EMBASE (1974 to June 2007). We also used the results from handsearching and consultations with manufacturers and authors.

Selection criteria
Randomised or quasi-randomised trials evaluating the effects of tetanus toxoid in pregnant women or women of childbearing age on numbers of neonatal tetanus cases and deaths.

Data collection and analysis
Three review authors independently assessed trials for inclusion and trial quality, and extracted data.

Main results
Two trials (10,560 infants) were included. One study (1919 infants) assessed the effectiveness of tetanus toxoid in preventing neonatal tetanus deaths. After a single dose, the relative risk (RR) was 0.57 (95% confidence interval (CI) 0.26 to 1.24), and the vaccine effectiveness was 43%. With a two or three dose course, the RR was 0.02 (95% CI 0.00 to 0.30); vaccine effectiveness was 98%. No effect was detected on causes of death other than tetanus. The RR of cases of neonatal tetanus after at least one dose of tetanus toxoid was 0.20 (95% CI 0.10 to 0.40); vaccine effectiveness was 80%. Another study, involving 8641 children, assessed the effectiveness of tetanus-diptheria toxoid in preventing neonatal mortality after one or two doses. The RR was 0.68 (95% CI 0.56 to 0.82); vaccine effectiveness was 32%. In preventing deaths at 4 to 14 days, the RR was 0.38 (95% CI 0.27 to 0.55), and vaccine effectiveness 62% (95% CI 45% to 73%).

Authors' conclusions
Available evidence supports the implementation of immunisation practices on women of childbearing age or pregnant women in communities with similar, or higher, levels of risk of neonatal tetanus, to the two study sites. More information is needed on possible interference of vaccination by malaria chemoprophylaxis on the roles of malnutrition and vitamin A deficiency, and on the quality of tetanus toxoid production and storage.

Plain language summary

Vaccines for women to prevent neonatal tetanus
Vaccinating childbearing women against tetanus rather than influenza or cholera appears to decrease incidence of tetanus in newborn babies but possible adverse effects not assessed.

Neonatal tetanus is an infection causing rigidity, muscle spasm and often death in newborn babies. It is quite common in income-poor countries and comes from insufficient protection being passed from mother to baby in utero together with infection getting into the baby through the umbilical cord stump. The review of two studies (10,560 infants) assessing vaccinating women of childbearing age showed fewer cases of neonatal tetanus when two or three doses were used, but no potential adverse effects were assessed. Administrative and operational aspects also need to be of good quality for vaccination programmes to be effective.


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