Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare a Technology Assessment Report. The Technology Assessment Report for this technology appraisal was prepared by University of Sheffield, School of Health and Related Research (ScHARR) (see the "Availability of Companion Documents" field).
Clinical Effectiveness
Sources Searched
Keyword and thesauri searches were undertaken in Medline, CINAHL, Embase, BIOSIS, Science Citation Index, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Health Technology Assessment database and NHS Economic Evaluations Database. Websites containing registers of trials and ongoing research were also searched. These included the National Research Register and the MetaRegister of the Current Controlled Trials website. In addition, the bibliographies of retrieved papers (including the previous review) were scrutinised.
Keyword Strategies
Sensitive keyword strategies using free-text and, where available, thesaurus terms were developed to search the electronic databases. Synonyms relating to the intervention (e.g., Rh-Hr Blood-Group System, Rho(D) Immune Globulin, Rh Isoimmunisation and anti-d prophylaxis) were combined with synonyms relating to the patient population (e.g., pregnancy, pregnancy complications, pregnancy trimesters, prenatal care, postnatal care).
Search Restrictions
A methodological filter aimed at identifying controlled clinical trials (including before and after studies) was used in the searches of Medline, Embase and Cinahl. Further filters were used to identify papers relating to cost/s and systematic reviews. Language restrictions were not used on any database, and no date restrictions were applied. All searches were undertaken between May and August 2006.
A copy of the general search strategy may be found in Appendix 1 of the Assessment Report (see the "Availability of Companion Documents" field).
Specific systematic searches for adverse event data were not undertaken, and the clinical review therefore includes only adverse event data reported by the included studies.
Inclusion and Exclusion Criteria
Inclusion Criteria
Population: Pregnant women who are rhesus D (RhD)-negative
Intervention: Routine antenatal anti-D prophylaxis (RAADP) using either 2 doses of at least 500 international units (IU) at 28 and 34 weeks' gestation or a single dose of at least 1500 IU at 28 weeks' gestation, in either case followed, if the infant is RhD-positive, by a further dose of anti-D given at, or within 72 hours of, delivery.
Comparator
- RAADP using different dosing regimens and/or methods of administration
- No RAADP
Outcomes
- Sensitisation (alloimmunisation) rates among RhD-negative women delivered of RhD-positive infants (the at-risk population)
- Incidence of haemolytic disease of the newborn (HDN)
- Survival of the child
- Disability of the child
- Health-related quality of life
- Adverse effects of treatment
Study design: any of:
- Systematic reviews
- Randomised controlled trials
- Non-randomised controlled trials
Exclusion Criteria
Studies considered methodologically unsound, or not reporting results in the necessary detail.
Cost-Effectiveness
A systematic review of economic evaluations was carried out using the search criteria and databases set out for the clinical effectiveness (see above); the only variation from this being the study design criteria defined as economic evaluations.