Why women do not accept randomisation for place of birth: feasibility of a RCT in the Netherlands

被引:65
作者
Hendrix, M. [1 ]
Van Horck, M. [1 ]
Moreta, D. [1 ]
Nieman, F. [2 ]
Nieuwenhuijze, M. [3 ]
Severens, J. [2 ,4 ]
Nijhuis, J. [1 ]
机构
[1] Maastricht Univ Med Ctr, Dept Obstet & Gynaecol, NL-6202 AZ Maastricht, Netherlands
[2] Maastricht Univ Med Ctr, Dept Clin Epidemiol & Med Technol Assessment KEMT, NL-6202 AZ Maastricht, Netherlands
[3] Univ Midwifery Educ & Studies Maastricht, Dept Clin Epidemiol & Med Technol Assessment KEMT, Maastricht, Netherlands
[4] Maastricht Univ Med Ctr, Fac Hlth Sci, Dept Hlth Org Policy & Econ, NL-6202 AZ Maastricht, Netherlands
关键词
Home birth; hospital birth; randomised controlled trial; the Netherlands; RANDOM ALLOCATION; INFORMED-CONSENT; CLINICAL-TRIALS; PARTICIPATION; PREFERENCES; HOME;
D O I
10.1111/j.1471-0528.2008.02103.x
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
The purpose of this study was to investigate why low-risk nulliparae were not willing to participate in a randomised controlled trial (RCT) of place of birth. Prospective study. The Netherlands. All low-risk nulliparous women starting their pregnancy under midwife. A questionnaire for 107 nulliparae who were willing to participate in a cohort study on place of birth, but at an earlier stage in their pregnancy declined to participate in a RCT of place of birth. This questionnaire included 12 items on a 4-point Likert scale but was not subjected to formal validation. Reasons why nulliparae did not accept randomisation of place of birth. The most important reason why women refused participation in the trial was that they had already chosen their place of birth before they were asked to participate at 12 weeks of pregnancy. From their answers, it became clear that pregnant women strongly value their autonomy of choice. The decision not to participate in the trial was not influenced by the information given by the midwife and the additional written information. Factors that prevent randomisation for place of birth are difficult to influence. There is a need to explore why there is such certainty of view among women having their first child. Until we have an understanding of why women select information to make these choices and why women are reluctant to participate in trials that challenge choice, it may well be impossible to mount a trial of place of birth.
引用
收藏
页码:537 / 542
页数:6
相关论文
共 19 条
[1]  
[Anonymous], 2005, EPIDEMIOLOGISCH ONDE
[2]   The concept of validity [J].
Borsboom, D ;
Mellenbergh, GJ ;
van Heerden, J .
PSYCHOLOGICAL REVIEW, 2004, 111 (04) :1061-1071
[3]   Offering patients entry in clinical trials: Preliminary study of the views of prospective participants [J].
Corbett, F ;
Oldham, J ;
Lilford, R .
JOURNAL OF MEDICAL ETHICS, 1996, 22 (04) :227-231
[4]  
Dowswell T, 1996, BRIT MED J, V312, P753
[5]   Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial [J].
Featherstone, K ;
Donovan, JL .
BMJ-BRITISH MEDICAL JOURNAL, 1998, 317 (7167) :1177-1180
[6]   Home-like versus conventional institutional settings for birth [J].
Hodnett, ED ;
Downe, S ;
Edwards, N ;
Walsh, D .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2005, (01)
[7]   Choosing a birth attendant: The influence of a woman's childbirth definition [J].
HowellWhite, S .
SOCIAL SCIENCE & MEDICINE, 1997, 45 (06) :925-936
[8]   The preferences of 600 patients for different descriptions of randomisation [J].
Jenkins, V ;
Fallowfield, L ;
Cox, A .
BRITISH JOURNAL OF CANCER, 2005, 92 (05) :807-810
[9]   Describing randomisation: patients' and the public's preferences compared with clinicians' practice [J].
Jenkins, V ;
Leach, L ;
Fallowfield, L ;
Nicholls, K ;
Newsham, A .
BRITISH JOURNAL OF CANCER, 2002, 87 (08) :854-858
[10]   Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy [J].
Jenkins, V ;
Fallowfield, L .
BRITISH JOURNAL OF CANCER, 2000, 82 (11) :1783-1788