A randomised double-blind trial to determine the bleeding profile of the prolonged-release contraceptive dienogest 2 mg/ethinylestradiol 0.02 mg versus an immediate-release formulation of drospirenone 3 mg/ethinylestradiol 0.02 mg.

BACKGROUND: Dienogest (DNG) 2 mg/ethinylestradiol (EE) 0.02 mg is the first low-dose combined oral contraceptive (COC) with a prolonged-release formulation that allows stable plasma concentrations and has high contraceptive efficacy (Pearl index: 0.2). The aim of this trial was to determine the bleeding profile of this contraceptive compared to an immediate release formulation. METHODS: This prospective double-blind randomised controlled trial evaluated the bleeding patterns of DNG 2 mg/EE 0.02 mg compared with immediate-release drospirenone (DRSP) 3 mg/EE 0.02 mg in a 24/4-day regimen over nine cycles (randomisation ratio, 5:2). Participants recorded scheduled and unscheduled bleeding/spotting data using an electronic diary. A non-inferiority analysis for the proportion of participants with unscheduled bleeding/spotting was prespecified for Cycles 2-6. Safety, including adverse events, were monitored throughout the trial. RESULTS: Seven-hundred six and 288 participants received DNG/EE and DRSP/EE, respectively. Scheduled bleeding patterns per each 28-day cycle were similar in both groups. During Cycles 2-6, the proportion of participants with unscheduled bleeding/spotting was significantly lower in the DNG/EE group (50.5% [280/574] than in the DRSP/EE group (72.8% [171/235]]; treatment difference 22.3% [95% CI 15.9, 28.6%]; p < 0.0001). A low proportion of participants discontinued the trial due to bleeding disorders (1.7% and 0.7%, respectively). The safety profiles were similar for both treatments. CONCLUSIONS: The prolonged-release DNG 2 mg/EE 0.02 mg offers a significant decrease in unscheduled bleeding/spotting compared with an immediate-release COC, DRSP/EE, combined with high contraceptive efficacy and a very low adverse event profile.

The prolonged-release DNG 2 mg/EE 0.02 mg offers a significant decrease in unscheduled bleeding compared with an immediate-release COC while maintaining contraceptive efficacy and with no new safety signals.

The efficacy, safety, and tolerability of an estrogen-free oral contraceptive drospirenone 4 mg (24/4-day regimen) in obese users.

OBJECTIVES: This study aimed to compare contraceptive efficacy and safety of drospirenone 4 mg in a 24/4-day regimen in nonobese and obese users and describe pharmacokinetics according to bodyweight. STUDY DESIGN: We analyzed data from three drospirenone 4 mg trials (2 European and 1 United States) to report outcomes in nonobese (body mass index <30 kg/m2) and obese (body mass index ≥30 kg/m2) users. We used data from the US trial to calculate the Pearl Index (pregnancies per 100 woman-years) in nonbreastfeeding participants aged ≤35 years at enrollment for confirmed pregnancies. We assessed safety outcomes from all trials based on reported treatment-emergent adverse events. We evaluated pharmacokinetics by bodyweight in the US trial. RESULTS: The three trials combined comprised 2152 nonobese and 425 obese participants, including 590 nonobese and 325 obese participants in the US trial. Eight nonobese and four obese participants had confirmed pregnancies in the US trial, resulting in Pearl Indices of 3.0 (95% CI: 1.3-5.8) and 2.9 (95% CI: 0.8-7.3), respectively. Two-hundred forty-four (11.3%) nonobese and 39 (9.2%) obese participants discontinued due to a treatment-emergent adverse event. The pharmacokinetic analysis included 814 participants with a median weight of 73 (interquartile range 61-89) kg and median plasma drospirenone exposure (AUC0-24ss) of 661.3 (interquartile range 522-828) ng∙h/mL. Changing bodyweight from the median to the fifth percentile (51 kg) or 95th percentile (118 kg) changed drospirenone exposure (AUC0-24,ss) by 22.2% and -23.6%, respectively. CONCLUSIONS: Drospirenone 4 mg demonstrated similar contraceptive efficacy for both nonobese and obese users despite a difference in exposure based on bodyweight. IMPLICATIONS: Our limited comparison between obese and nonobese users of drospirenone-only oral contraception demonstrated no evidence that efficacy or discontinuation for adverse events differs between groups. Serum drospirenone levels vary by bodyweight and may correlate with bleeding outcomes.

Sutura de B Lynch, para el control de la hemorragia posparto: presentación de tres casos / B Lynch suture for control of postpartum hemorrhage: report of three cases

Informar el resultado de 3 casos de hemorragia posparto, tratados con la técnica de suturas de B-Lynch, previo masaje uterino y administración de medicamentos. Las pacientes fueron atendidas en el Servicio de Obstetricia y Ginecología del Hospital Miguel Pérez Carreño, en el período comprendido entre enero de 2011 a junio de 2011. Se presentan 3 casos en los que se realizó la técnica de sutura de B-Lynch, para el control de la hemorragia posparto. En los 3 casos se logró exitosamente controlar la hemorragia posparto y preservar el útero. Nuestros resultados permiten afirmar que la técnica de B-Lynch es segura, útil y reproducible en el manejo de la hemorragia posparto

To report the results of 3 cases of postpartum hemorrhage treated with the technique of B-Lynch suture, uterine massage prior administration of medications. Patients were treated at the Department of Obstetrics and Gynecology, Hospital Miguel Perez Carreno, in the period from January 2011 to June 2011. 3 show cases where the technique was performed for B-Lynch suture, to control postpartum hemorrhage. In all 3 cases was successfully manage postpartum hemorrhage and preserve the uterus. Our results suggest that the B-Lynch technique is safe, useful and reproducible in the management of postpartum hemorrhage