Valverde 2011.
| Methods | Prospective RCT. | |
| Participants | Pregnant women with a full‐term singleton fetus in cephalic presentation admitted to the dilatation and birth sections of the Department of Obstetrics and Gynecology at Virgen de las Nieves University Hospital in Granada, Spain. NRFHR patterns were recorded during the second stage of labour as per Garite et al. 2000. N = 90 in each group. |
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| Interventions | Group 1: pulse oximetry and intrapartum CTG. Group 2: fetal ECG (spiral electrode on the scalp) and intrapartum CTG. |
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| Outcomes | Maternal: outcome of labour, rate of caesarean birth, rate of intervention due to NRFHR, reason for the intervention, duration of each stage of labour. Neonatal: cord blood acid base (arterial and venous), Apgar score, type of resuscitation, rate of admission to the NICU. |
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| Notes | After informed consent was obtained, an examination was performed to determine fetal well‐being with the scalp stimulation test and membranes were ruptured, if they had not already ruptured. All participants were offered epidural anaesthesia. Fetal oximetry: FS14 sensor and Nellcor 400 Fetal Oxygen Saturation Monitoring System. Normal values FSpO2 were defined as between 30% and 70%, with 30% as the cut‐off value. If FSpO2 below 10%, labour was terminated and between 10% and 30% additional information to determine the fetus’s acid‐base was sought. Fetal ECG: : Electrode Cetro AB, Neoventa, Molndal, Sweden. We have had no response from the authors to our request for the study protocol or whether or not the sealed opaque randomisation envelopes were sequentially numbered. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table. |
| Allocation concealment (selection bias) | Unclear risk | Sealed opaque envelopes. It is unclear whether or not these were sequentially numbered. |
| 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 does not state whether or not outcome assessors were blinded to group allocation. Clarification from authors was sought, with no response. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition was reported and relevant results were reported for all 180 participants. |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
| Other bias | Low risk | No evidence of other bias, although there is no evidence of trial registration or study protocol publication. |
CTG: cardiotocography ECG: fetal electrocardiography FBS: fetal blood sampling (scalp) FPO: fetal pulse oximetry FSpO2: fetal oxygen saturation value
HIV: human immunodeficiency virus NICU: neonatal intensive care unit NRFHR: nonreassuring fetal heart rate min: minute RCT: randomised controlled trial