Kuhnert 2004.
Methods | Single‐centre, RCT. | |
Participants | 146 women in labour. Inclusion criteria: CTG with International Federation of Gynecology and Obstetrics (FIGO) score ≦ 8, gestational age ≧ 36 weeks, active labour, single fetus, cephalic presentation, cervical dilatation of at least 2 cm and at station ‐2 or below, ruptured amniotic membranes (or have amniotomy). All cases had FBS prior to randomisation. Exclusion criteria: planned caesarean section, placenta praevia, need for immediate birth, active genital herpes or known HIV infection. |
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Interventions | Control group: fetal heart rate monitoring (CTG) and FBS. Protocol for action with reassuring, suspicious and pathologic CTG and FBS pH values. Intervention group: CTG plus FBS plus FPO. Protocol for action with reassuring (≧ 30%) and nonreassuring FPO values (< 30% for ≧ 10 mins or repeatedly ('summation effect')), and for reassuring and nonreassuring CTG and FBS pH. |
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Outcomes | Caesarean section or vacuum extraction for pathologic CTG; caesarean section or vacuum extraction for all indications; caesarean section or vacuum for arrest of labour; caesarean section for pelvic malformation or amnioinfection; vacuum extraction for maternal exhaustion; spontaneous vaginal birth; fetal heart rate patterns; FBS (including pH). Neonatal outcomes including: umbilical cord blood gases; resuscitation; admission to NICU. Maternal outcomes: 'adverse maternal events'. |
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Notes | Some additional unpublished data were provided by the authors (use of antibiotics, haemorrhage, chorioamnionitis, endometritis, uterine rupture, length of hospital stay, satisfaction with labour and fetal monitoring, death, neonatal skin trauma, Apgar score, umbilical arterial base excess, admission to neonatal intensive care, hypoxic‐ischaemic encephalopathy, seizures, long‐term disability). No details of the assessment of long‐term disability were provided (e.g. age of the infant, assessments made). Sample size calculation: no. Fetal oximetry system used: Nellcor OxiFirst. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random allocation: method not stated and not provided on request. |
Allocation concealment (selection bias) | Unclear risk | Unclear. No details provided in the report. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were unblinded. It would not have been feasible to blind the clinician or participant, given that FSpO2 values were used for clinical judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The report states "data acquisition was done anonymously for both groups". It is unclear whether this related to de‐identifying the data (likely) or that the data were collected without knowledge of group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of incomplete outcome data. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
Other bias | Unclear risk | The results are very different to those of the other studies in this review. No evidence of other bias, although there is no evidence of trial registration or study protocol publication. |