Tongsong 1994.
Methods | Randomisation: randomisation method unknown. Effectiveness of randomisation was assessed by comparisons of several parameters within the 2 groups which include maternal ages, gestational ages and primary indications. All the FHR tracings were interpreted blindly by 1 independent perinatologist, who did not have any clinical information on the group of women. | |
Participants | Women of least 28 weeks' gestation with indications including postterm pregnancy, intrauterine growth retardation, pregnancy‐induced hypertension, chronic hypertension, decreased fetal movement and diabetes mellitus. Country: Thailand. 1273 women randomised. | |
Interventions | Women randomised to fetal acoustic stimulation group were given fetal acoustic stimulation for 1 second. If no qualifying acceleration was observed within 15 seconds, the stimulus were repeated up to 3 times. If reactive criteria were not achieved in 10 minutes, a new cycle of stimulation was begun. If both the women in the acoustic stimulation and standard non‐acoustic stimulation groups did not meet the reactive criteria within 20 minutes of the tests, the same technique was extended another 20 minutes. | |
Outcomes | Primary outcome: FHR reactivity. This was defined by the presence of 2 FHR accelerations or more of greater than 15 bpm and of 15 seconds' duration within a 20‐minute period. 1 prolonged acceleration of the FHR of at least 15 bpm lasting more than 2 minutes was also interpreted as reactive. If these criteria were not met in 40 minutes of monitoring, the test was interpreted as non‐reactive. | |
Notes | All acoustic tests were performed in the Maternal Fetal Medicine Unit by a specially trained physician with the woman in semi‐Fowler's position. Transabdominal acoustic stimulation overlying the fetal vertex was accomplished with an electronic fetal larynx of approximately 80 db and frequency of 80 Hz and a stimulation duration of 1 second. Randomisation was done after informed consent. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method unknown. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding (performance bias and detection bias) All outcomes | Low risk | All the FHR tracings were interpreted blindly by one independent perinatologist, who did not have any clinical information on the group of women. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | Unclear. |
bpm: beats per minute BPPS: biophysical profile score db: decibels FHR: fetal heart rate Hz: hertz NICU: neonatal intensive care unit NST: non‐stress test VAS: vibroacoustic stimulation