Objectives: Cervical length (CL) measurement ≤ 25 mm on mid-trimester ultrasound scan is a known risk factor for preterm birth, for which vaginal progesterone is recommended. The aims of this study were to evaluate whether CL measurement is affected by observer bias and to assess the impact on short cervix prevalence of masking CL measurement during routine mid-trimester ultrasound scan.
Methods: This was a flash study designed for a 2-month period (October and November 2018) at Cruces University Hospital (Bizkaia, Spain), in which all CL measurements from routine mid-trimester scans were masked. During the study period, there was no modification of the routine screening method, and women with a short cervix were prescribed 200 mg vaginal progesterone daily as per usual. The control group included women examined in a 2-month period (April and May 2018) prior to the study, in which CL measurements were taken as usual by a non-blinded operator. The primary outcome was the prevalence of short cervix in each group.
Results: A total of 983 CL measurements were analyzed, including 457 in the blinded group and 526 in the control group. The prevalence of short cervix was 2.7% in the non-blinded group and 5.5% in the blinded group (P = 0.024). We identified a statistically significant difference in the incidence of CL of 24-25 mm between the two groups, with a lower prevalence in the non-blinded vs blinded group (0.6% vs 2.4%; P < 0.005). Moreover, the distribution of CL values was normal in the blinded group, in contrast to the non-blinded group, which was characterized by skewed distribution of CL values.
Conclusions: Expected-value bias exists and should be taken into account when measuring CL in mid-trimester preterm birth screening. Blinding has demonstrated to be an effective strategy to improve the performance of CL screening in clinical practice. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
Keywords: blinding; cervical length; expectancy bias; expected-value bias; observer bias; obstetric ultrasound; preterm birth screening; short cervix.
© 2021 International Society of Ultrasound in Obstetrics and Gynecology.