Cervical assessment certification and its impact on performance quality in the context of universal cervical screening.

OBJECTIVE: To assess the impact of the introduction of universal transvaginal cervical screening and certification on the quality of cervical length ultrasound images. METHODS: The present study included a retrospective cohort of singleton pregnancies that underwent transvaginal cervical length measurement at the anatomical scan (180/7 and 236/7 weeks) before (period A, 2015-2017) and after (period B, 2017-2019) the introduction of universal transvaginal cervical length screening. Independent observers blindly evaluated the images obtained for cervical length using a qualitative scoring method based on five criteria, according to the Fetal Medicine Foundation. RESULTS: In all, 6013 patients met the inclusion criteria, 3333 in period A and 2680 in period B. Maternal characteristics and risk factors for preterm birth were similar between the two periods. The acceptance of transvaginal cervical length measurement in period B was 95.5% in the overall cohort and 100% in the subgroup of high-risk patients. The quality score was significantly higher in period B than in period A. Among the image quality criteria, the anterior/posterior ratio, the correct magnification of the images, and the calipers' placement contributed significantly to the improved quality score in period B. Most of the sonographers performed better in period B, irrespective of the years of experience, but certificate holders obtained higher scores than non-certified sonographers, particularly those in mid-career. The identification of short cervix was significantly higher in period B than in period A. CONCLUSION: The implementation of universal transvaginal cervical length screening and the certification process are associated with improved quality of cervical length images, even among expert sonographers and in the presence of anatomical pitfalls.

Erratum to: Progesterone supplementation for HIV-positive pregnant women on protease inhibitor-based antiretroviral regimens (the ProSPAR study): a study protocol for a pilot randomized controlled trial.

[This corrects the article DOI: 10.1186/s40814-016-0087-6.].

Progesterone supplementation for HIV-positive pregnant women on protease inhibitor-based antiretroviral regimens (the ProSPAR study): a study protocol for a pilot randomized controlled trial.

BACKGROUND: In Canada, the majority of HIV-positive pregnant women receive combination antiretroviral therapy that includes a ritonavir-boosted protease inhibitor to prevent mother-to-child HIV transmission. However, protease inhibitor-based combination antiretroviral therapy has been associated with increased rates of preterm, low birth weight, and small for gestational age births. Our previous experimental findings demonstrate that protease inhibitor use during pregnancy is associated with decreased progesterone levels that correlate with fetal growth, and that progesterone supplementation can improve protease inhibitor-induced fetal growth restriction. We hypothesize that HIV-positive pregnant women who receive protease inhibitor-based combination therapy may also benefit from progesterone supplementation during pregnancy. METHODS/DESIGN: In order to test this hypothesis, we have designed an open-label, multi-centre, randomized controlled (parallel group) pilot trial. The initial goal of this trial is to test feasibility and acceptability of our intervention. Forty HIV-positive pregnant women who are either on, or intending to start or switch to a boosted protease inhibitor-based combination antiretroviral regimen will be enrolled from six sites across Ontario, Canada. Twenty-five women will be randomized to self-administer natural progesterone (Prometrium, 200 mg) vaginally every night starting between gestational week 16 and 24 until week 36, and 15 women will be randomized to no intervention. While the participants and treating physicians will not be blinded, the laboratory personnel performing the biochemical and morphological evaluations will be blinded to ensure unbiased evaluation. The primary outcome of the pilot study is the feasibility of enrolment as measured by the recruitment rate and patient-reported reasons to decline participation. Secondary outcomes in participants include safety, acceptability, and adherence to progesterone supplementation. DISCUSSION: Given the safety of intravaginal progesterone and its current use in the general obstetrical population to prevent recurrent preterm delivery, this pilot study will provide data to determine the feasibility of a larger randomized controlled trial to assess the impact of this intervention on improving neonatal health in the context of HIV-positive pregnancies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02400021.