Klauser 2005.
Methods | Single‐centre RCT. | |
Participants | 360 women in labour. Control group: 1 post randomisation exclusion as no consent. Intervention group: 30 post randomisation exclusions where FPO sensor not placed and 2 additional exclusions due to randomisation issues. Inclusion criteria: nonreassuring CTG, ≧ 28 weeks' gestation, single fetus, cephalic presentation, cervical dilatation of at least 2 cm and at station ‐5 or below, ruptured amniotic membranes (spontaneous or artificial). Exclusion criteria: planned caesarean section, contraindication to vaginal birth (including genital herpes, transverse lie), unexplained vaginal bleeding, placenta praevia, ominous CTG requiring immediate birth, known HIV infection, hepatitis B or C, unable to give consent due to intrapartum parenteral analgesia. |
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Interventions | Control group: fetal heart rate monitoring (CTG) (Doppler/fetal scalp electrode). Study group: CTG plus fetal pulse oximetry (Nellcor OxiFirst). Protocol for action with reassuring fetal oximetry (≧ ≥30%) and nonreassuring values (< 30% for 3 minutes). |
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Outcomes | Primary outcome: caesarean section for nonreassuring fetal status. Maternal outcomes: caesarean section for all indications; caesarean section for dystocia; amnioinfusion and length of labour. Neonatal outcomes including: Apgar scores; umbilical cord blood gases; resuscitation; admission to NICU. |
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Notes | Further data were requested, no response. Sample size calculation: yes, based on reduction in caesarean section rate for nonreassuring fetal status. This was revised following the interim analysis due to a higher than anticipated caesarean section rate in the control group, meaning that a 50% reduction in caesareans would require less participants than originally though. The study ceased at that time. 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 | The method of randomisation not stated. No response from request to the authors for clarification. |
Allocation concealment (selection bias) | Unclear risk | Unclear. No mention in the report, although two participants were excluded on the basis of "randomization issues". |
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 | It is unclear if the outcome assessors were blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of incomplete outcome data ‐ the flowchart in the published report accounts for all those enrolled. The trial was ceased following an interim analysis, at which time it was determined that a total of 300 of the original planned 400 would have adequate power to detect a 50% reduction in the primary outcome, caesarean section. Some recruitment occurred while the interim analysis was in progress, meaning that a total of 327 women were randomised. Of these, there were 32 postrandomisation exclusions in the fetal oximetry group and 1 in the control group, |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. The flowchart in the published report accounts for all those enrolled. |
Other bias | Low risk | No evidence of other bias, although there is no evidence of trial registration or study protocol publication. |