Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.
The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.
This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.
The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.
NCT06677554; 2024-511720-13-00.
Pre-eclampsia and fetal growth restriction (FGR) are two principal complications of pregnancy related to placental dysfunction. Nevertheless, knowledge of the underlying pathophysiological mechanisms remains inadequate, and only a few tools are available for in vivo assessment of placental perfusion. Contrast-enhanced ultrasound (CEUS) allows organ vascularisation evaluation via a strictly intravascular gas microbubble. The primary aim of this study is to compare placental vascularisation parameters obtained via CEUS between pregnancies with FGR and those without FGR.
This is a single-centre, prospective, comparative, non-randomised, feasible, open and interventional study. We will include 30 women with medical termination of pregnancy divided into two groups: one with severe FGR and the other without FGR. Severe FGR is defined as an estimated fetal weight below the third percentile for gestational age. Women will be informed and recruited in the fetal medicine unit over a period of 48 months. The primary goal of this study is to compare the placental contrast ultrasound parameter measurements according to group. The primary objective is to compare placental contrast ultrasound data in women who undergo medical termination of pregnancy at a gestational age of 16 weeks (38+6 days) between two groups: a group with FGR and a group without FGR. The secondary objectives are as follows: (1) to describe the placental vascularisation parameters measured by CEUS; (2) to describe the parameters for quantifying vascularisation at different gestational ages via CEUS; (3) to study the associations between CEUS data and placental histological data and (4) to establish a biological collection of placentas to increase our knowledge of the development and functions of the placenta during pregnancy. The statistical analysis will include descriptive analysis for all study patients, with quantitative data described by means±SDs, medians, IQRs, and extreme values and qualitative data reported as counts and percentages. Comparisons of placental contrast ultrasound parameters between the two groups will be performed via Student’s t-test or the Mann-Whitney U test on the basis of data normality. Associations between CEUS parameters and placental histology data will be analysed with Spearman or Pearson correlations. Qualitative associations will be studied via analysis of variance or the Kruskal-Wallis test. Box plot representations will be used when applicable. Analyses will be performed with R software, with significance set at p
This study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD EST II – LYON – FRANCE, on 26 April 2024, with reference number 2023-506936-34-00, and the competent authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 17 May 2024. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.
NCT06497959; EU CT number: 2023-506936-34-00.