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1.
Contraception ; 126: 110134, 2023 10.
Article in English | MEDLINE | ID: mdl-37524147

ABSTRACT

OBJECTIVES: This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. STUDY DESIGN: In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment. RESULTS: We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy. CONCLUSIONS: Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe. IMPLICATIONS: Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.


Subject(s)
Abortifacient Agents, Nonsteroidal , Abortifacient Agents, Steroidal , Abortion, Induced , Abortion, Spontaneous , Misoprostol , Pregnancy, Ectopic , Pregnancy , Female , Humans , Mifepristone/adverse effects , Misoprostol/adverse effects , Abortifacient Agents, Nonsteroidal/adverse effects , Abortifacient Agents, Steroidal/therapeutic use , Retrospective Studies , Cicatrix/chemically induced , Cicatrix/drug therapy , Abortion, Induced/adverse effects , Abortion, Induced/methods , Pregnancy, Ectopic/diagnosis , Multicenter Studies as Topic
2.
Contraception ; 123: 110021, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36940910

ABSTRACT

OBJECTIVES: To describe treatment and outcomes of patients with confirmed cesarean scar ectopic pregnancy (CSEP) at a tertiary referral center. STUDY DESIGN: We reviewed a deidentified family planning clinical database for patients seen by our subspecialty service for CSEP from January 2017 through December 2021 in this case series. We extracted referral information, final diagnosis, management, and outcome measures including estimated blood loss, secondary procedures, and treatment complications. RESULTS: Of 57 cases referred for suspected CSEPs, 23 (40%) had confirmed diagnoses; one additional case was diagnosed during clinic evaluation for early pregnancy loss. Most (n = 50 [88%]) referrals occurred in the last 2 years of the 5-year study period. Of 24 confirmed CSEP cases, eight were pregnancy losses at the time of diagnosis. Fourteen cases were ≤50 days gestation or gestational size (7 [50%] pregnancy losses) and 10 >50 days gestation (range 39-66 days). We treated all 14 patients ≤50 days primarily with suction aspiration under ultrasound guidance in an operating room with no complications and estimated blood loss of 14 ± 10 mL. Of the 10 patients>50 days (maximum 66 days), seven were managed with primary aspiration of which five were uncomplicated. We treated one patient (57 days) had primary intrauterine double-catheter balloon with immediate hemorrhage requiring uterine artery embolization followed by an uncomplicated suction aspiration. CONCLUSIONS: Patients with confirmed CSEPs at 50 days or less gestation or gestational size can likely be primarily treated with suction aspiration with low risk for significant adverse outcomes. Treatment success and complications are directly related to gestational age at treatment. IMPLICATIONS: Ultrasound-guided suction aspiration monotherapy should be considered for primary CSEP treatment up to 50 days and, with continued experience, may be reasonable beyond 50 days gestation. Invasive treatments or those that require multiple days and visits, such as methotrexate or balloon catheters, are not necessary for early CSEPs.


Subject(s)
Cicatrix , Pregnancy, Ectopic , Pregnancy , Female , Humans , Cicatrix/complications , Cicatrix/drug therapy , Cesarean Section/adverse effects , Pregnancy, Ectopic/etiology , Pregnancy, Ectopic/therapy , Pregnancy, Ectopic/diagnosis , Methotrexate/therapeutic use , Referral and Consultation , Retrospective Studies
4.
J Minim Invasive Gynecol ; 28(5): 1013-1021, 2021 05.
Article in English | MEDLINE | ID: mdl-33152533

ABSTRACT

STUDY OBJECTIVE: To examine opioid prescribing and consumption patterns after hysterectomy and identify factors associated with postoperative opioid consumption. DESIGN: Prospective cohort study. SETTING: Single university medical center. PATIENTS: Women undergoing hysterectomy for benign, nonobstetric indications. INTERVENTIONS: Participant preoperative and surgical characteristics were obtained through chart review and patient report of baseline pain score. During the third postoperative week, participants completed a telephone interview, including a direct count of remaining opioid pills and assessment of satisfaction with pain management. We assessed factors associated with opioid consumption in oral morphine equivalents (OME) using a linear regression model. MEASUREMENTS AND MAIN RESULTS: Of the 129 participants, 113 (88%) completed the postoperative survey after hysterectomy: 16 vaginal, 43 robotic-assisted, 42 conventional laparoscopic, and 12 abdominal hysterectomies. The median amount of opioid prescribed was 150 OME (interquartile range [IQR] 113-200), while the median amount consumed was 75 (IQR 10-135), reflecting an average consumption of about 50% of the prescription. Opioid prescription size was associated with consumption; for every additional oral morphine equivalent prescribed, on average, an additional 0.5 was consumed (p <.001). If the indication for hysterectomy was related to pain, participants consumed 25.3 additional OME (p = .04). The amount of opioid prescribed was inversely correlated with pain management satisfaction; every additional point on a 1 through 5 Likert scale of increasing satisfaction was associated with 44 fewer OME prescribed (standard error 9 OME, p <.001). For the 1464 total unused pills among the 104 participants with leftover opioids, only 20% reported an Food and Drug Administration -compliant opioid disposal plan. CONCLUSION: Gynecologic surgeons can respond to the opioid epidemic by reducing excess opioid pills after hysterectomy by providing both the smallest effective prescription size and concrete resources for safe opioid disposal. These actions may contribute to a reduction in opioid use disorder cases or overdose deaths.


Subject(s)
Analgesics, Opioid , Pain, Postoperative , Female , Humans , Hysterectomy/adverse effects , Pain, Postoperative/drug therapy , Pain, Postoperative/etiology , Practice Patterns, Physicians' , Prospective Studies
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