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CLINICAL TRIAL
COMMENT
COMPARATIVE STUDY
ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
[More moderate neonatal morbidity in the case of non-randomized vaginal delivery of term breech pregnancies].
Nederlands Tijdschrift Voor Geneeskunde 2001 August 12
OBJECTIVE: To compare the outcome of term breech pregnancies by planned caesarean section or by planned vaginal delivery at the Department of Obstetrics and Gynaecology, Atrium Medisch Centrum Heerlen, the Netherlands, with the findings in the so-called 'Term breech trial' (TBT).
DESIGN: Randomised and descriptive non-randomised clinical trial.
METHOD: During the period of participation in the TBT prospective data were collected on all deliveries of a term baby in breech presentation. The pregnant women who were included in the TBT (n = 35) were randomised in a planned caesarean section (CS) group and a planned vaginal delivery (VD) group. All women with a child in term breech presentation who did not join the trial constituted the non-randomised group (n = 201) and were divided in a primary CS group (n = 48) and a started VD group (n = 153). Neonatal and maternal mortality and morbidity were analysed according to the intended mode of delivery.
RESULTS: Neither neonatal nor maternal mortality occurred in any of the groups. No significant differences in serious neonatal and maternal morbidity were observed between both subgroups in either the randomised or non-randomised group. However, in the non-randomised group who were allowed to start a vaginal delivery, moderate neonatal morbidity was significantly higher (25/153) than in the primary CS group (2/48).
CONCLUSION: The differences in serious neonatal morbidity as observed in the TBT were not confirmed in this study. However, there were disadvantageous differences in the moderate neonatal morbidity for the non-randomised group who were allowed to start a vaginal delivery. In addition to the TBT results, these findings might be discussed with women with a term breech presentation.
DESIGN: Randomised and descriptive non-randomised clinical trial.
METHOD: During the period of participation in the TBT prospective data were collected on all deliveries of a term baby in breech presentation. The pregnant women who were included in the TBT (n = 35) were randomised in a planned caesarean section (CS) group and a planned vaginal delivery (VD) group. All women with a child in term breech presentation who did not join the trial constituted the non-randomised group (n = 201) and were divided in a primary CS group (n = 48) and a started VD group (n = 153). Neonatal and maternal mortality and morbidity were analysed according to the intended mode of delivery.
RESULTS: Neither neonatal nor maternal mortality occurred in any of the groups. No significant differences in serious neonatal and maternal morbidity were observed between both subgroups in either the randomised or non-randomised group. However, in the non-randomised group who were allowed to start a vaginal delivery, moderate neonatal morbidity was significantly higher (25/153) than in the primary CS group (2/48).
CONCLUSION: The differences in serious neonatal morbidity as observed in the TBT were not confirmed in this study. However, there were disadvantageous differences in the moderate neonatal morbidity for the non-randomised group who were allowed to start a vaginal delivery. In addition to the TBT results, these findings might be discussed with women with a term breech presentation.
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