PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial.

BACKGROUND: Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ (POLE) ultramutated, and 'no specific molecular profile' (NSMP). Retrospective data imply that the response to adjuvant therapies may depend on the molecular subgroup. These findings emphasize the need for adjuvant therapy trials where patients are randomized to treatment arms separately within each molecular subgroup. PRIMARY OBJECTIVE: The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial clarifies the value of molecular classification in the determination of adjuvant therapies of high-intermediate risk and early-stage high-risk endometrial carcinoma. STUDY HYPOTHESIS: Compared with vaginal brachytherapy, the utilization of whole pelvic radiotherapy may result in improved outcomes for either MMRd or NSMP high-intermediate risk carcinomas. Early-stage high-risk p53abn and nonendometrioid carcinomas are postulated to gain benefits from chemoradiotherapy, as opposed to chemotherapy alone. POLE ultramutated carcinomas harboring high-intermediate or high-risk clinicopathologic features are speculated to have favorable prognosis without any adjuvant therapy. TRIAL DESIGN: This prospective, multicenter, phase 3 trial compares the efficacy of vaginal brachytherapy vs whole pelvic radiotherapy in high-intermediate risk MMRd and NSMP molecular subgroups, and chemotherapy vs chemoradiotherapy in early-stage high-risk p53abn subtype and nonendometrioid carcinomas. Eligible women who consent to participation in the trial are randomly allocated (1:1) to treatment arms. MAJOR INCLUSION/EXCLUSION CRITERIA: Women with stages I-II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included. PRIMARY ENDPOINT: The primary endpoint is the 5 year cumulative incidence of disease recurrence. SAMPLE SIZE: A total sample size of 294 patients (49 subjects in each treatment arm of the three subgroups intended for randomization) was estimated to be sufficient. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Patient recruitment will be completed in 2025, and follow-up will be completed in 2030. TRIAL REGISTRATION: NCT05655260.

Is there an association between postpartum hemorrhage, interventional radiology procedures, and psychological sequelae?

BACKGROUND: Postpartum hemorrhage (PPH) may cause post-traumatic psychological sequelae. Interventional radiology procedures (IRP) have been established in the management of PPH when conventional management fails. IRP is also used prophylactically in women who are at high risk for PPH in pregnancies with abnormally invasive placentation. We sought to determine if there is an association between PPH, IRP, and psychological sequelae. OBJECTIVES: Seventy-three women who underwent IRP due to PPH or were at high risk for PPH. METHOD: A structured questionnaire was sent to all women. RESULTS: Overall 49 women returned the questionnaire. Two-thirds of the women developed psychological sequelae and one-third reported a lack of professional support. Nine women had symptoms of post-traumatic stress disorder. Psychological sequelae were not associated with a volume of bleeding, whether or not hysterectomy was performed, or whether the IRP was performed as an emergency procedure or prophylactically. However, women who had elective IRP and no hysterectomy performed had significantly less fear of death compared to the rest of the study population. CONCLUSIONS: We observed a high rate of psychological sequelae associated with IRP. Lack of proper professional support may have contributed to the development of post-traumatic psychological sequelae suggesting a need for debriefing in such women.

Major or minor placenta previa: Does it make a difference?

INTRODUCTION: Placenta previa is a severe pregnancy complication with considerable maternal and neonatal morbidity. Placenta previa can be defined as major or minor by location. Major placenta previa is associated with higher complication rates. Management of women with minor placenta previa has not been well defined. The primary goal of the study was to evaluate the accuracy of our existing screening protocol for placenta previa. Secondly, we wanted to compare pregnancy and delivery outcomes by the type of placenta previa. METHODS: The study was conducted at the Helsinki University Hospital between June 2010 and September 2014. The study population consisted of all women with the antenatal ultrasound diagnosis of placenta previa during delivery. Data were retrospectively collected and analysed. RESULTS: Altogether 176 women had placenta previa at delivery (major 129, minor 47). Placenta previa remained undiagnosed at second trimester screening ultrasound in 32 women (18.2%). Twenty (62.5%) of these cases had minor placenta previa and 12 (37.5%) had major placenta previa. Five (15.6%) of the undiagnosed cases developed life-threatening hemorrhage (≥2500 ml) during the delivery and two had abnormally invasive placenta followed by hysterectomy. Women with major placenta previa had significantly more blood loss and delivered earlier than women with minor placenta previa. The groups were otherwise similar, including the rate of abnormally invasive placenta. DISCUSSION: The existing protocol for placenta previa missed almost one fifth of cases. Both major and minor placenta previa are risk factors for abnormally invasive placenta and should be treated as severe conditions.

Pelvic arterial embolization in severe obstetric hemorrhage.

Massive postpartum hemorrhage (PPH) is a major life-threatening complication. When conventional management fails, pelvic arterial embolization (PAE) can be used. The aim of our study was to find out the success rate of PAE in cases of acute PPH, and to study the safety of this procedure in a retrospective case series from a tertiary teaching hospital. Forty-five women with acute PPH were managed by PAE. Hospital charts were reviewed. The most common causes of PPH in cases treated with PAE were lower genital tract injury (40%), placental retention (36%) and uterine atony (13%). The overall success rate was 89%. Five of the 45 women needed additional procedures. The overall complication rate was 9%. We conclude that PAE is a safe and effective procedure for PPH and may prevent hysterectomy.

Use of Bakri balloon tamponade in the treatment of postpartum hemorrhage: a series of 50 cases from a tertiary teaching hospital.

OBJECTIVE: Massive postpartum hemorrhage (PPH) is one of the most serious complications during delivery. Hysterectomy is commonly performed when other conventional treatment attempts fail. Bakri balloon tamponade (BBT) is a novel conservative management option for PPH. Little is known of the effectiveness of this procedure. We report a large case series from a tertiary teaching hospital. DESIGN: Retrospective case series (October 2008-June 2011). SETTING: University teaching hospital. POPULATION: Forty-four women with massive PPH (blood loss >1000 mL) and six other women with expected high risk of PPH (blood loss <1000 mL) managed by BBT. METHODS: Chart review. MAIN OUTCOME MEASURES: Achievement of definitive hemostasis by BBT among the study population. RESULTS: Among the women treated with BBT, the cause of PPH was uterine atony (16%), cervical rupture (14%), vaginal rupture and/or paravaginal hematoma (22%), placenta previa (18%) and placental retention (30%). The overall success rate was 86%. Seven of the 50 patients needed additional procedures. Of the seven failures, supravaginal uterine amputation or hysterectomy was required in four cases and embolization of the uterine arteries in three cases. CONCLUSIONS: BBT is a simple, readily available, effective and safe procedure for the management of PPH in selective cases. BBT does not exclude the use of other procedures if necessary. Even if BBT failed, it may provide temporary tamponade and time to prepare for other interventions or transportation from local hospital to tertiary centre. We suggest that BBT should be included in the PPH protocol.