Intramyometrial and intravenous oxytocin compared to intravenous carbetocin for prevention of postpartum hemorrhage in elective cesarean section-A quasi-randomized controlled phase IV non-inferiority interventional trial.

INTRODUCTION: Our objective was to assess non-inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non-inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland. MATERIAL AND METHODS: The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Subjects were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 µg IV). Non-inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe-Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum-Hb postpartum) ≥30 g/L. RESULTS: Non-inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00-0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0-19.0] vs. 11 [5.0-17.0], p = 0.07), estimated blood loss (median 500 [IQR 400-600] vs. 500 [400-575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (-0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non-significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (-476.5 to 1419.3), p = 0.33). CONCLUSIONS: Combined (IM/IV) oxytocin is not non-inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.

Success Rate and Long-Term Effects of Embolization of Pelvic Arteries for the Treatment of Postpartum Hemorrhage.

Introduction: Postpartum hemorrhage (PPH) is the leading cause of peripartal maternal mortality and accounts for 25% of all maternal deaths worldwide. The most common reasons of PPH are uterine atony, retained placenta, or placenta accreta spectrum. Treatment of PPH depends on the etiology and corresponds to a stepwise approach, which follows the German, Austrian and Swiss guideline for the diagnosis and therapy of PPH in Switzerland. In severe ongoing PPH, hysterectomy has been the ultima ratio for many decades. Nowadays, interventional embolization of the pelvic arteries (PAE) has become a popular alternative. Besides being a highly effective minimally invasive method, PAE avoids hysterectomy with consecutively reduced morbidity and mortality. However, data on the long-term effects of PAE on fertility and menstrual cycle are scarce. Methods: We performed a monocentric study consisting of a retro- and a prospective part including all women who had undergone a PAE between 2012 and 2016 at University Hospital Zurich. Descriptive characteristics of patients and efficacy of PAE defined as cessation of bleeding were analyzed retrospectively. In the prospective part, all patients were contacted for a follow-up questionnaire regarding menstruation and fertility after embolization. Results: Twenty patients with PAE were evaluated. Our data showed a success rate of PAE in 95% of patients with PPH; only 1 patient needed a second, then successful, PAE. No patient needed a hysterectomy or any other surgical intervention. In our study, an association between mode of delivery and identified etiology of PPH is observed. After spontaneous delivery (n = 6), the main reason of severe PPH was retained placenta (n = 4), while after cesarean section (n = 14), uterine atony was identified in most cases (n = 8). Regarding menstruation after embolization, all women reported regular menstruation after the breastfeeding period (100%). The majority reported a regular pattern with a shorter or similar duration (73%) and lower or similar intensity (64%). Dysmenorrhea decreased in 67% of patients. Four patients planned another pregnancy, of whom only one had become pregnant with assisted reproductive technology and ended up in a miscarriage. Discussion: Our study confirms the efficacy of PAE in PPH, thus obviating complex surgical interventions and associated morbidity. The success of PAE does not depend on the primary cause of PPH. Our results may encourage the prompt decision to perform PAE in the management of severe PPH in case of failure of conservative management and help physicians in the post-interventional counseling regarding menstruation patterns and fertility.