Early
Human
Development,
29 (1992)
309
309-312
Elsevier Scientific Publishers Ireland Ltd. EHD 01294
Evaluation of different policies for the management of labour G. Br6arta, N. Mlika-Cabanea, M. Kaminski”, S. Alexander, A. Herruzo-Nalda, P. Mandruzzato, J.G. Thornton and D. Trakas nEpidemiology
Research
Unit on Women Port-Royal,
and Child Health (INSERM-V.149), 75014 Paris (France)
123 Boulevard
de
Summary Varioius policies of management of prolonged labour have been proposed to prevent its two main consequences - caesarean section and fetal distress. Two randomised controlled trials were organised; the first to assess the value of amniotomy with oxytocin compared to a more conservative approach. The second trial compared the effect of continuous professional support duirng labour with the intermittent presence of a member of staff. These were multicentre studies in several countries of Europe. Preliminary results of early amniotomy suggested no difference in the rate of operative delivery. Continuous professional support was associated with a significant reduction in operative deliveries.
Key words: prolonged labour; caesarean section; amniotomy
Introduction As a result of a meeting held in Brussels in 1984 [l] it was decided to organize a European concerted action on ‘Evaluation of perinatal care delivery systems’ which is coordinated by one of us (M.K.). Within this concerted action, the objective of one subproject is the evaluation of different policies for the management of labour. The aim of this paper is to describe the rationale, the objectives and the methodology of the project and to give some preliminary results.
Correspondence to: G. Brkart, Epidemiology Research Unit on Women and Child Health (INSERMU.l49), 123 Boulevard de Port-Royal, 75014 Paris, France.
310
Rationale Various policies of management of prolonged labour have been proposed to prevent its two main consequences, caesarean section and fetal distress. The three main policies advocated are amniotomy, intravenous oxytocin infusion and psychological support (social or professional) during labour. These three policies are all part of the ‘Active Management of Labour’ as advocated originally by O’Driscoll and derived from his work at the National Maternity Hospital in Dublin [2]. Proper evaluation of these policies can only be made in the light of results from randomised controlled trials. A major advantage claimed for active management has been a low caesarean section rate and therefore the rate of operative delivery must be a major endpoint of any study, together with assessment of neonatal condition. Among the published trials reviewed by Keirse et al. [3,4] only those by Sosa and Klaus have shown a significant difference in caesarean section rates. However, their results were not replicated in recent European studies. Similarly, trials evaluating amniotomy and/or oxytocin infusion have failed to show any differences in outcome (including both mode of delivery and neonatal condition). These results do not necessarily mean that the interventions are without effect because the decision to perform a caesarean section relies on many factors which may not be influenced by amniotomy or oxytocin infusion. Outcomes may be more dependent on the attitudes of the birth attendants to dystocia than anything which can be modified by amniotomy or oxytocin infusion. Objective of the project The objective of the project is to answer the following two questions: - Is it possible to decrease the rate of operative deliveries and to increase the satisfaction of the mothers, without affecting the health of the neonates by modifying the policies of management of labour? - What will be the economical implications of such modification? Methods To reach this objective two randomized controlled trials were organized [5]. The first R.C.T. (Trial A) is assessed the value of early amniotomy together with oxytotin compared to a more conservative approach. Twenty-two centers in four countries (France, Italy, United Kingdom and Spain) were accepted to participate in this trial (Table I). The second R.C.T. (Trial B) is comparing the effect of continuous professional support during labour with intermittant presence of the member of the staff. Ten centers in three countries (Belgium, France, Greece) were accepted to participate in this trial (Table II). For every woman included in the trial a medical questionnaire was filled in. In Belgium (Trial B), France (Trials A and B), Spain (Trial A) and United Kingdom (Trial A) a psychological questionnaire was administered. It concerns all the women in France and Belgium and a sample of them in the United Kingdom. For economical evaluation, participating units tilled a questionnaire.
311 TABLE I Number of women included in trial of early amniotomy. Country and national coordinator
Early amniotomy
Control group
France (G. Brtart) Italy (P. Mandruzzato) Spain (A. Herruzo-Nalda) UK (J. Thornton)
989
979
651
452
279
275
668
589
Population The -
eligibility criteria for the two trials were the following: Primiparous women Singleton birth Spontaneous labour Vertex presentation Full term Dilatation
Human
Development,
29 (1992)
309
309-312
Elsevier Scientific Publishers Ireland Ltd. EHD 01294
Evaluation of different policies for the management of labour G. Br6arta, N. Mlika-Cabanea, M. Kaminski”, S. Alexander, A. Herruzo-Nalda, P. Mandruzzato, J.G. Thornton and D. Trakas nEpidemiology
Research
Unit on Women Port-Royal,
and Child Health (INSERM-V.149), 75014 Paris (France)
123 Boulevard
de
Summary Varioius policies of management of prolonged labour have been proposed to prevent its two main consequences - caesarean section and fetal distress. Two randomised controlled trials were organised; the first to assess the value of amniotomy with oxytocin compared to a more conservative approach. The second trial compared the effect of continuous professional support duirng labour with the intermittent presence of a member of staff. These were multicentre studies in several countries of Europe. Preliminary results of early amniotomy suggested no difference in the rate of operative delivery. Continuous professional support was associated with a significant reduction in operative deliveries.
Key words: prolonged labour; caesarean section; amniotomy
Introduction As a result of a meeting held in Brussels in 1984 [l] it was decided to organize a European concerted action on ‘Evaluation of perinatal care delivery systems’ which is coordinated by one of us (M.K.). Within this concerted action, the objective of one subproject is the evaluation of different policies for the management of labour. The aim of this paper is to describe the rationale, the objectives and the methodology of the project and to give some preliminary results.
Correspondence to: G. Brkart, Epidemiology Research Unit on Women and Child Health (INSERMU.l49), 123 Boulevard de Port-Royal, 75014 Paris, France.
310
Rationale Various policies of management of prolonged labour have been proposed to prevent its two main consequences, caesarean section and fetal distress. The three main policies advocated are amniotomy, intravenous oxytocin infusion and psychological support (social or professional) during labour. These three policies are all part of the ‘Active Management of Labour’ as advocated originally by O’Driscoll and derived from his work at the National Maternity Hospital in Dublin [2]. Proper evaluation of these policies can only be made in the light of results from randomised controlled trials. A major advantage claimed for active management has been a low caesarean section rate and therefore the rate of operative delivery must be a major endpoint of any study, together with assessment of neonatal condition. Among the published trials reviewed by Keirse et al. [3,4] only those by Sosa and Klaus have shown a significant difference in caesarean section rates. However, their results were not replicated in recent European studies. Similarly, trials evaluating amniotomy and/or oxytocin infusion have failed to show any differences in outcome (including both mode of delivery and neonatal condition). These results do not necessarily mean that the interventions are without effect because the decision to perform a caesarean section relies on many factors which may not be influenced by amniotomy or oxytocin infusion. Outcomes may be more dependent on the attitudes of the birth attendants to dystocia than anything which can be modified by amniotomy or oxytocin infusion. Objective of the project The objective of the project is to answer the following two questions: - Is it possible to decrease the rate of operative deliveries and to increase the satisfaction of the mothers, without affecting the health of the neonates by modifying the policies of management of labour? - What will be the economical implications of such modification? Methods To reach this objective two randomized controlled trials were organized [5]. The first R.C.T. (Trial A) is assessed the value of early amniotomy together with oxytotin compared to a more conservative approach. Twenty-two centers in four countries (France, Italy, United Kingdom and Spain) were accepted to participate in this trial (Table I). The second R.C.T. (Trial B) is comparing the effect of continuous professional support during labour with intermittant presence of the member of the staff. Ten centers in three countries (Belgium, France, Greece) were accepted to participate in this trial (Table II). For every woman included in the trial a medical questionnaire was filled in. In Belgium (Trial B), France (Trials A and B), Spain (Trial A) and United Kingdom (Trial A) a psychological questionnaire was administered. It concerns all the women in France and Belgium and a sample of them in the United Kingdom. For economical evaluation, participating units tilled a questionnaire.
311 TABLE I Number of women included in trial of early amniotomy. Country and national coordinator
Early amniotomy
Control group
France (G. Brtart) Italy (P. Mandruzzato) Spain (A. Herruzo-Nalda) UK (J. Thornton)
989
979
651
452
279
275
668
589
Population The -
eligibility criteria for the two trials were the following: Primiparous women Singleton birth Spontaneous labour Vertex presentation Full term Dilatation
