Evaluating use of IOTA two‐step strategy to classify adnexal masses identified in pregnancy: pilot study

ABSTRACT Objectives The primary aim was to validate the International Ovarian Tumor Analysis (IOTA) benign simple descriptors (BDs) followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model, if BDs cannot be applied, in a two‐step strategy to classify adnexal masses identified during pregnancy. The secondary aim was to describe the natural history of adnexal masses during pregnancy. Methods This was a retrospective analysis of prospectively collected data from women with an adnexal mass identified on ultrasonography during pregnancy between 2017 and 2022 at Queen Charlotte's and Chelsea Hospital, London, UK. Clinical and ultrasound data were extracted from medical records and ultrasound software. Adnexal masses were classified and managed according to expert subjective assessment (SA). Borderline ovarian tumors (BOTs) were classified as malignant. BDs were applied retrospectively to classify adnexal masses, and if BDs were not applicable, the ADNEX model (using a risk‐ of‐malignancy threshold ≥ 10%) was used, in a two‐step strategy. The reference standard was histology (where available) or expert SA at the postnatal ultrasound scan. Results A total of 291 women with a median age of 33 (interquartile range (IQR), 29–36) years presented with an adnexal mass during pregnancy, at a median gestational age of 12 (IQR, 8–17) weeks. Of those, 267 (91.8%) were followed up to the postnatal period. Based on the reference standard, 4.1% (11/267) of adnexal masses were classified as malignant (all BOTs) and 95.9% (256/267) as benign. BDs were applicable in 68.9% (184/267) of adnexal masses; of these, only one (0.5%) BOT was misclassified as benign. The ADNEX model was used to classify the 83 residual masses and misclassified 3/10 (30.0%) BOTs as benign and 25/73 (34.2%) benign masses as malignant, of which 13/25 (52.0%) were classified as decidualized endometrioma on expert SA. The two‐step strategy had a specificity of 90.2%, sensitivity of 63.6%, negative predictive value of 98.3% and positive predictive value of 21.9%. A total of 56 (21.0%) women underwent surgical intervention: four (1.5%) as an emergency during pregnancy, four (1.5%) electively during Cesarean section and 48 (18.0%) postnatally. During follow‐up, 64 (24.0%) adnexal masses resolved spontaneously. Cyst‐related complications occurred in four (1.5%) women during pregnancy (ovarian torsion, n = 2; cyst rupture, n = 2) and six (2.2%) women in the postnatal period (all ovarian torsion). Overall, 196/267 (73.4%) women had a persistent adnexal mass at postnatal ultrasound. Presumed decidualization occurred in 31.1% (19/61) of endometriomas and had resolved in 89.5% (17/19) by the first postnatal ultrasound scan. Conclusions BDs apply to most adnexal masses during pregnancy. However, the small number of malignant tumors in this cohort (4.1%) restricted the evaluation of the ADNEX model, so expert SA should be used to classify adnexal masses during pregnancy when BDs do not apply. A larger multicenter prospective study is required to evaluate the use of the ADNEX model to classify adnexal masses during pregnancy. Our data suggest that most adnexal masses can be managed expectantly during pregnancy, given the high rate of spontaneous resolution and low risk of complications. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.