Mifepristone versus balloon catheter for labor induction: a cohort study.

OBJECTIVE: to compare trans-cervical balloon catheter with oral administration of mifepristone for induction of labor. METHODS: Retrospective cohort study including a total of 325 patients; labor was induced with Foley catheter (group I, n = 220) or mifepristone (group II, n = 105). We selected patients with cervical ripening ≤5 cm according to Bishop score (n = 208) and divided into 2 subgroups depending on the parity: group I, primiparous with a Bishop score of ≤5, n = 70 - I (1, ≤5); group I, multiparous with a Bishop score of ≤5, n = 44 - I (2,≤5); group II, primiparous with a Bishop score of ≤5, n = 65 - II (1, ≤5); group II, multiparous with a Bishop score of ≤5, n = 29 - II (2, ≤5). Frequencies and percentages were presented using analysis of variance. RESULTS: Vaginal delivery occurred more frequently in patients induced by mifepristone (76.5%) vs. Foley catheter (74.5%). However, vaginal delivery within 24 h from the onset of induction occurred in the majority of patients in the Foley catheter groups: 39 (55.7%) and 28 (63.6%) versus 15 (23.1%) and 6 (20.7%) in groups induced with mifepristone. The frequency of cesarean section in the primiparas induced using a Foley catheter was 14%, with the use of mifepristone 21%. However, all multiparas induced with mifepristone delivered vaginally, in contrast to 30.7% of multiparas with the placement of a Foley catheter which required a cesarean delivery. CONCLUSION: Comparison of the effectiveness of induction of labor with the use of mifepristone and an intracervical balloon Foley catheter showed that both of these methods are successful, with more deliveries within the first 24 hrs achieved by using Foley catheter. The results of this study support the postulate that the success of an induction is largely dependent on the degree of cervical ripening and parity.

Obstetrical complications and outcome in patients with endometriosis.

Endometriosis is a disease that has a profound impact on the quality of life of women, due to the associated chronic pelvic pain, dysmenorrhea, dyspareunia and infertility. However, even getting long-awaited pregnancy (often after assisted reproductive technologies), patients with endometriosis have a high risk of obstetric complications, such as miscarriage, preterm birth, preeclampsia, placental abnormalities, hemorrhage in labor, birth of small for gestational age infants, stillbirth and higher cesarean section rate. In addition, during pregnancy acute complications of endometriosis may occur, such as spontaneous hemoperitoneum, which is rare but life-threatening conditions that in most cases require surgical intervention. The mechanisms of the observed complications in pregnant women with endometriosis are not fully understood. This review presents literature data and personal considerations on the effect of endometriosis on pregnancy outcome and the occurrence of complications, as well as their possible underlined mechanisms. Based on this, we proposed ways to reduce the risk of obstetric complications in pregnant women with a history of endometriosis.

Prolonged cyclical and continuous regimens of dydrogesterone are effective for reducing chronic pelvic pain in women with endometriosis: results of the ORCHIDEA study.

OBJECTIVE: To compare the effectiveness of two different treatment regimens of dydrogesterone in the management of endometriosis-related chronic pelvic pain. DESIGN: Observational, prospective cohort study over six months. SETTING: Twenty gynecology clinics in the Russian Federation. PATIENT(S): Three hundred fifty women from 18 to 45 years of age with endometriosis and chronic pelvic pain with or without dysmenorrhea. INTERVENTION(S): Dydrogesterone 10 mg 2 or 3 times daily, either between the 5th and 25th days of the menstrual cycle (prolonged cyclical treatment regimen) or continuously (continuous treatment regimen). For all patients, the data cutoff was at six months of treatment. MAIN OUTCOME MEASURE(S): Intensity of chronic pelvic pain on the 11-point numerical rating scale (after 6 months). RESULT(S): A marked reduction in chronic pelvic pain was observed with both the prolonged cyclical and continuous treatment regimens (mean ± standard deviation change from baseline -3.3 ± 2.2 and -3.0 ± 2.2, respectively), with no significant difference between the two groups. With both regimens, patients experienced significant improvements in the intensity of chronic pelvic pain, number of days in which analgesics were required, severity of dysmenorrhea, sexual well-being, and health-related quality-of-life parameters. A favorable safety profile of dydrogesterone was confirmed, and no serious adverse drug reactions were reported during the study. CONCLUSION(S): Prolonged cyclical and continuous treatment regimens of dydrogesterone therapy both demonstrated a pronounced and similar reduction in the severity of chronic pelvic pain and dysmenorrhea and led to marked improvements in all study parameters related to quality of life and sexual well-being. REGISTRATION NUMBER: NCT03690765.

Succinate-Based Dietary Supplement for Menopausal Symptoms: A Pooled Analysis of Two Identical Randomized, Double-Blind, Placebo-Controlled Clinical Trials.

BACKGROUND: To evaluate the efficacy of a succinate-based dietary supplement (SBDS; Amberen) in symptomatic menopausal women using a larger sample size derived by pooling data from two identical trials. METHODS: Raw data were pooled from two identical randomized, multicenter, double-blinded, placebo-controlled, 90-day clinical trials. Women aged 42-60 years with mild to moderate vasomotor and psychosomatic menopausal symptoms were included (114 in the treatment group and 113 in the placebo group). Symptoms were assessed by the Greene Climacteric Scale and State-Trait Anxiety Inventory. Changes in body mass index, body weight, waist and hip circumferences, and plasma levels of follicle stimulating hormone, luteinizing hormone, estradiol, leptin, and apolipoproteins A1 and B were also evaluated. RESULTS: SBDS use resulted in significant improvements in several endpoints including alleviation of 16 of 21 menopausal symptoms (p ≤ 0.05, Greene Scale) and a decrease in anxiety (p < 0.0001, State-Trait Anxiety Inventory) when compared to placebo. Significant reductions were observed in weight, body mass index, and waist and hip circumferences in the supplement cohort. Evaluation of physiological parameters showed a significant increase in serum estradiol levels compared to baseline (p < 0.0001) among users of the SBDS. Levels of follicle stimulating hormone and luteinizing hormone decreased slightly in both groups, without significant differences between the groups. Leptin levels decreased with statistical significance in the SBDS cohort compared to placebo (p=0.027). For those with initial leptin concentrations above the reference range, leptin decreased significantly in the SBDS group compared to the baseline (p < 0.0001) and to placebo (p=0.027). CONCLUSIONS: The pooled analysis reaffirms the outcomes from the individual trials. A nonhormonal, succinate-based dietary supplement is shown to relieve menopausal symptoms when compared to a placebo regimen in a randomized, double-blinded clinical trial.