RESUMO
OBJECTIVE: To estimate whether routine use of intravenous oxytocin decreases the frequency of interventions to control excess blood loss during dilation and evacuation (D&E). METHODS: In this multisite, randomized, double-blind, placebo-controlled trial, women undergoing D&E at 18-24 weeks of gestation received 30 units of oxytocin in 500 mL of intravenous fluid or 500 mL of intravenous fluid alone initiated on speculum placement. The primary outcome was the frequency of interventions to control excess bleeding. A sample size of 75 patients per group was needed to detect a 15% decrease in intervention from 20% to 5% with 80% power and two-sided alpha 0.05. Secondary outcomes included measured blood loss, complications, procedure duration, postoperative pain, and patient satisfaction. RESULTS: From November 2014 to February 2018, we screened 337 women and randomized 160 to receive prophylactic oxytocin (n=82) or placebo (n=78). Demographic characteristics were similar between groups. The frequency of interventions for bleeding, our primary outcome, was 7.3% in the oxytocin group vs 16.7% in the placebo group, difference of 9.4% (95% CI -21.0% to 1.9%). Interventions primarily included uterine massage and uterotonic administration. Among our secondary outcomes, median measured blood loss was lower in the oxytocin group at 152 (interquartile range 98-235) mL vs 317 (interquartile range 168-464) mL (95% CI 71.6-181.5). Frequency of hemorrhage, defined as blood loss of 500 mL or more and 1,000 mL or more, was lower in the oxytocin group at 3.7% vs 21.8%, difference of 18% (95% CI -29 to -6.9%) and 1.2% vs 10.3%, difference of 9.0% (95% CI -17 to -0.7%), respectively. Procedures were shorter in the oxytocin group at a median of 11.0 (interquartile range 8.0-14.0) vs 13.5 (interquartile range 10.0-19.0) minutes in the placebo group (95% CI 1.0-4.0). We found no differences in the frequency of nonhemorrhage complications, pain scores, or satisfaction scores between groups. CONCLUSION: Prophylactic use of oxytocin during D&E at 18-24 weeks of gestation did not decrease the frequency of interventions to control bleeding. However, oxytocin did decrease blood loss and frequency of hemorrhage. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT02083809.
Assuntos
Aborto Induzido/efeitos adversos , Complicações Intraoperatórias/prevenção & controle , Ocitócicos/uso terapêutico , Ocitocina/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Hemorragia Uterina/prevenção & controle , Adolescente , Adulto , Volume Sanguíneo , Método Duplo-Cego , Feminino , Idade Gestacional , Humanos , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/terapia , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia , Gravidez , Hemorragia Uterina/etiologia , Hemorragia Uterina/terapia , Adulto JovemRESUMO
OBJECTIVE: To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. STUDY DESIGN: Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n=3). Group 2 animals (n=4) were treated once with MF. Group 3 (n=7) received a single, and Group 4 (n=5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. RESULTS: Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n=2) or three (n=3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. CONCLUSION: PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. IMPLICATIONS: This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.
Assuntos
Drogas em Investigação/administração & dosagem , Tubas Uterinas/efeitos dos fármacos , Polietilenoglicóis/administração & dosagem , Soluções Esclerosantes/administração & dosagem , Esterilização Tubária/efeitos adversos , Animais , Cateterismo Periférico , Relação Dose-Resposta a Droga , Esquema de Medicação , Avaliação Pré-Clínica de Medicamentos , Drogas em Investigação/efeitos adversos , Drogas em Investigação/farmacologia , Endométrio/irrigação sanguínea , Endométrio/efeitos dos fármacos , Endométrio/patologia , Epitélio/diagnóstico por imagem , Epitélio/efeitos dos fármacos , Epitélio/patologia , Tubas Uterinas/diagnóstico por imagem , Tubas Uterinas/patologia , Estudos de Viabilidade , Feminino , Fibrose , Histerossalpingografia , Laparoscopia , Macaca mulatta , Polidocanol , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/farmacologia , Soluções Esclerosantes/efeitos adversos , Soluções Esclerosantes/farmacologia , Ultrassonografia , Hemorragia Uterina/induzido quimicamente , Hemorragia Uterina/patologia , Cremes, Espumas e Géis Vaginais/administração & dosagem , Cremes, Espumas e Géis Vaginais/efeitos adversos , Cremes, Espumas e Géis Vaginais/farmacologiaRESUMO
As minor gynecologic procedures move from the operating room to the office, providers need to ensure that patients are comfortable and that procedures are performed safely. Although local anesthesia is commonly used for gynecologic procedures, a multimodal approach may be more effective. If necessary, sedation can be safely provided in an office setting with the correct tools and training. This article reviews evidence-based approaches to pain management for gynecologic procedures in the ambulatory setting.