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. 2017 Feb 13;2017(2):CD008680. doi: 10.1002/14651858.CD008680.pub2

Mahomed 1994.

Methods Prospective parallel randomised controlled trial, 1 centre.
Funding: this trial was funded by World Health Organization special programme for research, development and research training in human reproduction.
Participants Location: Harare maternity hospital, Zimbabwe, Africa. 1 centre.
Inclusion criteria: women consented antenatal. Women included were > 37 weeks' gestation, with obstetric and medical risk factors, in established labour, with singleton baby in cephalic presentation, cervical dilation ≤ 7 cm, normal FHR on admission (120‐160).
Exclusion criteria: women excluded from the trial were those presenting with placental abruption or eclampsia.
1255 pregnant women were recruited.
Interventions EFM group (n = 318): The intention was for a CTG with continuous trace via an external abdominal transducer for 10 minutes every half hour if normal tracing and every 20 minutes for 10 minutes if abnormal. Monitoring performed by a trained research midwife and doctor, strictly adhering to the research protocol.(*see notes)
Doppler group (n = 312): intermittent auscultation using hand‐held Doppler (ultrasonography), listening for 1 minute, during the last 10 minutes of each half hour, during and immediately after a contraction. Auscultation performed by a research midwife, who had been educated about the trial and its intervention, strictly adhering to the research protocol.
Intensive Pinard group (n = 310): intermittent auscultation with a Pinard stethoscope listening for 1 minute during the last 10 minutes of every half hour during and immediately after a contraction. Auscultation performed by a research midwife, who had been educated about the trial and its intervention, strictly adhering to the research protocol.
Routine Pinard group (n = 315): intermittent auscultation with a Pinard stethoscope as was routine at the involved hospital, which expected the FHR to be auscultated for 1 minute during last 10 minutes of every half hour during and immediately after a contraction. Auscultation would be performed by the midwife on‐duty, who may care for other labouring women at the same time and would endeavour to follow the hospital recommendation for routine auscultation as much as possible.
Outcomes Baby: Apgar < 6 at 5 minutes of birth, stillbirth or neonatal death, meconium‐stained liquor, admission to NICU/NNU, seizures in neonatal unit, hypoxic ischaemic encephalopathy, prolonged early and late FHR decelerations, abnormal FHR.
Mother: caesarean section for fetal distress, total caesarean section, operative (instrumental) vaginal delivery, spontaneous vaginal birth, spontaneous onset of labour, length of labour.
The results were recorded as a single rate.
Notes * A 10 min tracing was done but not with all participants. In this arm of the study 18 women birthed too quickly and 24 women had an unreadable tracing (frequent loss of contact, paper got stuck). It appears the FH was recorded as one number but late decelerations were noted on the 10 min tracing when they were present assisting with clinical management decisions.
There were a number of discrepancies in the way the interventions were described in different trial reports. In the 1992 article on page 460 there was a typo, it reads ' ... every 10 minutes if results were abnormal', should read "..every 20 minutes if..." (clarified via email with main trial author, Mahomed 1994)
Furthermore, the 1992 article reported that the nurse in charge applied the intervention of the routine group for fetal auscultation with a Pinard stethoscope. The 1994 article reported that is was the midwife on‐duty (clarified via email with main trial author (Mahomed 1994 that latter statement is correct).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... Eligible women were randomly allocated to one of four methods of monitoring intrapartum... The randomisation was performed with a random permuted block of 16 numbers..." (p. 498). It is not stated how the random permuted blocks were generated.
Allocation concealment (selection bias) Low risk Quote: " ...by means of serially numbered sealed opaque envelopes containing the allocation..."
(p. 498).
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding not stated, however it is unlikely that blinding would be possible with the nature of the interventions, as they were visibly different. Therefore considered as high risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details given.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There seems to be no loss of follow‐up, as numbers remain consistent.
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.
Other bias Low risk No other risk of bias identified. Groups appeared balanced at baseline.