Methodological considerations in the design of the WHO Antenatal Care Randomised Controlled Trial

Paediatric and Perinatal Epidemiology

Volumn 12, Issue SUPPL. 2, 1998, Pages 59-74

  Donner, A ^a   Piaggio, G ^b   Villar, J ^b   Pinol, A ^b   Al Mazrou, Y ^c   Ba'aqeel, H ^d   Bakketeig, L ^e   Belizan J M ^f   Berendes, H ^g   Carroli, G ^f   Farnot, U ^h   Lumbiganon, P ⁱ  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b WORLD BANK   (United States)

^c MINISTRY OF HEALTH   (Saudi Arabia)

^d KING KHALID HOSPITAL   (Saudi Arabia)

^e NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

^f Centro Rosarino de Estudios Perinatales   (Argentina)

^g EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^h HOSPITAL CLINICOQUIRÚRGICO HERMANOS AMEIJEIRAS   (Cuba)

ⁱ KHON KAEN UNIVERSITY   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; FEMALE; HEALTH PROGRAM; HUMAN; MAJOR CLINICAL STUDY; METHODOLOGY; PRENATAL CARE; RANDOMIZED CONTROLLED TRIAL; REPRODUCTION; WORLD HEALTH ORGANIZATION;

AMERICAS; ARAB COUNTRIES; ARGENTINA; ASIA; CARIBBEAN; CROSS SECTIONAL ANALYSIS; CUBA; DELIVERY OF HEALTH CARE; DEVELOPING COUNTRIES; HEALTH; HEALTH SERVICES; INTERNATIONAL AGENCIES; LATIN AMERICA; MATERNAL HEALTH SERVICES; MATERNAL-CHILD HEALTH SERVICES; NORTH AMERICA; ORGANIZATION AND ADMINISTRATION; ORGANIZATIONS; PRENATAL CARE; PRIMARY HEALTH CARE; PROGRAM EVALUATION; PROGRAMS; REPRODUCTIVE HEALTH; RESEARCH METHODOLOGY; SAUDI ARABIA; SOUTH AMERICA; SOUTHEASTERN ASIA; STUDY DESIGN; THAILAND; UN; WESTERN ASIA; WHO;

ARGENTINA; CUBA; DATA COLLECTION; DATA INTERPRETATION, STATISTICAL; FEMALE; HEALTH SERVICES RESEARCH; HUMANS; MULTICENTER STUDIES; PATIENT SELECTION; PREGNANCY; PRENATAL CARE; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SAUDI ARABIA; THAILAND; WORLD HEALTH ORGANIZATION;

EID: 17344372113     PISSN: 02695022     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-3016.1998.00007.x     Document Type: Article

References (16)

1. Villar J, Carroli G. Methodological issues of randomised controlled trials for the evaluation of reproductive health interventions. Preventive Medicine 1996; 25: 365-375.
2. Villar J, Bakketeig L, Donner A, Al-Mazrou Y, Ba'aqeel H, Belizán JM, et al. The WHO Antenatal Care Randomised Controlled Trial: rationale and study design. Paediatric and Perinatal Epidemiology 1998; 12 (Suppl. 2): 27-58.
3. Grant A, Elbourne D, Valentin L, Alexander S. Routine formal fetal movement counting and risk of antepartum late death in normally formed singletons. Lancet 1989; ii: 345-349.
4. Bullough C, Msuku R, Karonde L. Early suckling and postpartum haemorrhage; controlled trial in deliveries by traditional birth attendants. Lancet 1989; ii: 522-525.
5. Kendrick JS, Zahniser SC, Miller N, Salas N, Stine J, Gargiullo PM, et al. Integrating smoking cessation into routine public prenatal care: The Smoking Cessation in Pregnancy Project. American Journal of Public Health 1995; 85: 217-222.
6. Donner A, Klar N. Cluster randomisation trials in epidemiology: theory and application. Journal of Statistical Planning and Inference 1994; 40: 1-20.
7. Martin DC, Diehr P, Perrin EB, Koepsell TD. The effect of matching on the power of randomised community intervention studies. Statistics in Medicine 1993; 12: 329-338.
8. Klar N, Donner A. The merits of matching in community intervention trials. Statistics in Medicine 1997; 16: 1753-1764.
9. Donner A. Sample size requirements for stratified cluster randomisation designs. Statistics in Medicine 1992; 1: 743-750.
10. Feng Z, Grizzle JE. Correlated binomial variates: Properties of estimator of intraclass correlation and its effect on sample size calculation. Statistics in Medicine 1992; 11: 1607-1614.
11. Donner A, Birkett N, Buck C. Randomisation by cluster. Sample size requirements and analysis. American Journal of Epidemiology 1981; 114: 906-914.
12. Jones B, Jarvis P, Lewis JA, Ebbutt AR Trials to assess equivalence: the importance of rigorous methods. British Medical Journal 1996; 313: 36-39.
13. Fleiss JL. General design issues in efficacy equivalency and superiority trials. Journal of Periodontal Research 1992; 27: 306-313.
14. Zelen M. Randomised consent trials. Lancet 1992; 340: 375.
15. Pinol A, Bergel E, Chaisiri K, Díaz E, Gandeh M. Managing data for a randomised controlled clinical trial: experience from the WHO Antenatal Care Trial. Paediatric B Perinatal Epidemiology 1998; 12 (Suppl. 2): 142-155
16. Villar J, Kestler E, Pareja GP. Measurement error in clinical perinatal data. American Journal of Obstetrics and Gynecology 1989; 160: 380-382.