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1.
J Obstet Gynaecol Res ; 50(5): 856-863, 2024 May.
Article in English | MEDLINE | ID: mdl-38476034

ABSTRACT

AIM: Methotrexate has demonstrated efficacy in treating ectopic pregnancies. This study explores factors influencing treatment success, focusing on laboratory and ultrasonographic findings, particularly the day 4 to day 1 ß-hCG level ratio. METHODS: Retrospective cohort study was conducted within patients diagnosed with tubal ectopic pregnancy. Patients' characteristics, ultrasound findings, laboratory data, and ß-hCG levels (days 1, 4, 7), and operation findings were reviewed. Women's characteristics were investigated who were treated with single dose of MTX (50 mg/m2). Patients who were performed surgery after MTX treatment were identified as MTX treatment failure. RESULTS: Among 439 women, 259 underwent surgery due to acute symptoms. Of those treated with MTX, 143 experienced treatment success, while 37 underwent surgery after MTX (MTX failure). Comparative analysis revealed significant differences in ß-hCG levels on admission (1128 and 4125 mIU/mL) and the day 4 to day 1 ß-hCG ratio (0.91 and 1.25). The overall MTX success rate was 79%, reaching 93% and 89% for ß-hCG levels <1000 mIU/mL and <2000 mIU/mL, respectively. Success dropped to 50% with levels exceeding 5000 mIU/mL. ROC analysis identified a crucial 2255 mIU/mL cut-off for ß-hCG (sensitivity 70.3% and specificity 68.5%) and a day 4 to day 1 ß-hCG ratio of 95.5% (sensitivity 84.7%, specificity 72.5%, positive predictive value 75.4%) for predicting MTX success. CONCLUSION: Establishing a ß-hCG cutoff can reduce hospital stay. The day 4 to day 1 ß-hCG ratio holds promise as a widely applicable predictor for MTX success or for determining MTX administration on day 4.


Subject(s)
Abortifacient Agents, Nonsteroidal , Chorionic Gonadotropin, beta Subunit, Human , Methotrexate , Pregnancy, Ectopic , Humans , Methotrexate/administration & dosage , Female , Pregnancy , Adult , Retrospective Studies , Abortifacient Agents, Nonsteroidal/administration & dosage , Pregnancy, Ectopic/drug therapy , Pregnancy, Ectopic/blood , Chorionic Gonadotropin, beta Subunit, Human/blood , Treatment Outcome , Young Adult
2.
Fertil Steril ; 121(5): 824-831, 2024 May.
Article in English | MEDLINE | ID: mdl-38211763

ABSTRACT

OBJECTIVE: To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who conceived without medical assistance and those who conceived through in vitro fertilization (IVF), after fresh or frozen embryo transfer, and evaluate for the predictive factors of success, time to first passage of tissue, and time to complete resolution of pregnancy. DESIGN: Retrospective cohort study. SETTING: University hospital. PATIENT(S): Women who presented with EPL below 13 weeks of gestation between June 2013 and July 2021 who were managed medically with mifepristone 200 mg orally and misoprostol 800 mcg vaginally were included in the study. INTERVENTION(S): Medical management with mifepristone and misoprostol; conception without medical assistance vs. post-IVF, after fresh or frozen embryo transfer. MAIN OUTCOME MEASURE(S): We evaluated overall success and performed subgroup analysis according to the mode of conception and compared fresh vs. frozen-thawed embryo transfers for IVF pregnancies. In all groups, we also calculated success according to gestational age and compared the time to first passage of tissue. The potential predictive factors of treatment success were analyzed. The side effects and complications of treatment were recorded. RESULT(S): A total of 930 women were included in the study, 99 (11%) of whom achieved pregnancy after IVF. The overall success of medical treatment was 89% with no statistically significant difference according to the mode of conception (89% vs. 89%) or type of transfer (fresh 89% vs. frozen 89%). Only lower gestational age by sonography was independently predictive of treatment success, showing a negative regression coefficient of ß = -0.333 and an odds ratio of 0.717. The mean time to first passage of tissue was 5.0 ± 2.1 hours. Altogether, 666 women (72%) showed pregnancy resolution on the day of medication administration, an additional 110 women at 1-week follow-up, and a further 74 women after ≥4 weeks on ultrasound. CONCLUSION(S): Medical management of EPL with mifepristone and misoprostol is a highly successful treatment option that results in completed abortion in a timely fashion in both pregnancies conceived without medical assistance and those conceived after IVF.


Subject(s)
Abortion, Spontaneous , Embryo Transfer , Fertilization in Vitro , Mifepristone , Misoprostol , Humans , Female , Pregnancy , Retrospective Studies , Adult , Mifepristone/administration & dosage , Mifepristone/adverse effects , Mifepristone/therapeutic use , Fertilization in Vitro/methods , Misoprostol/administration & dosage , Misoprostol/adverse effects , Abortion, Spontaneous/epidemiology , Abortion, Spontaneous/etiology , Embryo Transfer/methods , Treatment Outcome , Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Nonsteroidal/adverse effects , Abortifacient Agents, Steroidal/administration & dosage , Abortifacient Agents, Steroidal/adverse effects , Administration, Oral
3.
Ultrasound Obstet Gynecol ; 62(2): 279-289, 2023 08.
Article in English | MEDLINE | ID: mdl-37058401

ABSTRACT

OBJECTIVE: To describe the clinical and sonographic characteristics of intramural pregnancy, as well as the available management options and treatment outcomes. METHODS: This was a retrospective single-center study of consecutive patients with a sonographic diagnosis of intramural pregnancy between November 2008 and November 2022. An intramural pregnancy was diagnosed on ultrasound when a pregnancy was implanted within the uterine corpus, above the level of the internal cervical os and separate from the interstitial section of the Fallopian tube, and extended beyond the decidual-myometrial junction. Clinical, ultrasound, relevant surgical and histological information and outcomes were retrieved from each patient's record and analyzed. RESULTS: Eighteen patients were diagnosed with an intramural pregnancy during the study period. Their median age was 35 (range, 28-43) years and the median gestational age at diagnosis was 8 + 1 (range, 5 + 5 to 12 + 0) weeks. Vaginal bleeding with or without abdominal pain was the most common presenting symptom, recorded in eight patients. Nine (50%) patients had a partial and nine (50%) had a complete intramural pregnancy. Embryonic cardiac activity was present in eight (44%) pregnancies. The majority of pregnancies (n = 10 (56%)) were initially managed conservatively, including expectant management in eight (44%) cases, local injection of methotrexate in one (6%) and embryocide in one (6%). Conservative management was successful in nine of the 10 (90%) pregnancies, with a median time to serum human chorionic gonadotropin resolution of 71 (range, 35-143) days. One patient with an ongoing live pregnancy had an emergency hysterectomy for a major vaginal bleed at 20 weeks' gestation. No other patient managed conservatively experienced any significant complication. The remaining eight (44%) patients had primary surgical treatment, comprising transcervical suction curettage in seven (88%) of these cases, while one patient presented with uterine rupture and underwent emergency laparoscopy and repair. CONCLUSIONS: We describe the ultrasound features of partial and complete intramural pregnancy, demonstrating key diagnostic features. Our series suggests that, when intramural pregnancy is diagnosed before 12 weeks' gestation, it can be managed either conservatively or by surgery, with preservation of reproductive function in most women. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.


Subject(s)
Myometrium , Pregnancy, Ectopic , Ultrasonography , Humans , Female , Pregnancy , Pregnancy, Ectopic/diagnostic imaging , Adult , Myometrium/diagnostic imaging , Retrospective Studies , Uterine Hemorrhage/etiology , Methotrexate/administration & dosage , Abortifacient Agents, Nonsteroidal/administration & dosage
4.
Int J Gynaecol Obstet ; 161(2): 624-630, 2023 May.
Article in English | MEDLINE | ID: mdl-36495245

ABSTRACT

OBJECTIVE: To examine the combined effect of a medical and mechanical method on induction-to-abortion interval (IAI) in women undergoing early mid-trimester abortion (MTA) (13-20 weeks of pregnancy). METHODS: A randomized controlled trial was conducted among women undergoing MTA. Primary outcome was IAI. At enrollment, 60 women were randomized (group 1: medical method alone [mifepristone 200 mg, then 48 h later vaginal misoprostol 400 µg every 4 h] versus group 2: combined medical and mechanical method [transcervical Foley catheter inflated with 60 ml of normal saline]). Demographic and clinical data were collected at enrollment and abortion. RESULTS: Women in group 2 had statistically significantly shorter IAI (mean ± standard deviation: 347 ± 130 min vs. 640 ± 242 min, for group 2 and group 1, respectively; P < 0.001). All the women in group 2 had complete abortion within 12 h, compared with 19 (63%) in group 1 (P < 0.001). Median number of doses of vaginal misoprostol (400 µg every 4 h) required in group 1 was 4 (interquartile range [IQR] 3-5) versus 1 (IQR 1-3) in group 2 (P < 0.001). Statistically significantly fewer women required additional oxytocin (group 1 vs. group 2; 4 vs. zero, respectively, P = 0.038). All women in the study had complete abortion. There was no significant difference with respect to maternal complications. CONCLUSION: A combined medical and mechanical method significantly shortens the IAI (P < 0.001) in women undergoing early MTA (13-20 weeks of pregnancy). TRIAL REGISTRATION: Clinical Trial Registry of India www.ctri.nic.in CTRI/2020/12/030077 (date; 28-12-2020).


Subject(s)
Abortifacient Agents, Nonsteroidal , Abortion, Induced , Misoprostol , Humans , Female , Adult , Pregnancy , Abortifacient Agents, Nonsteroidal/administration & dosage , Abortion, Induced/methods , Misoprostol/administration & dosage , Pregnancy Trimester, Second , Pregnancy Trimester, First , Oxytocin
5.
Ultrasound Obstet Gynecol ; 59(1): 100-106, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34523740

ABSTRACT

OBJECTIVE: To compare the reproductive outcome after early miscarriage between women managed expectantly and those treated with vaginal misoprostol. METHODS: This study was a planned secondary analysis of data collected prospectively in a randomized controlled trial comparing expectant management with vaginal misoprostol treatment (single dose of 800 µg) in women with early embryonic or anembryonic miscarriage and vaginal bleeding. The outcome measures were the number of women with a clinical pregnancy conceived within 14 months after complete miscarriage and the outcome of these pregnancies in terms of live birth, miscarriage, ectopic pregnancy and legal termination of pregnancy. The participants replied to a questionnaire sent by post covering their reproductive history ≤ 14 months after the index miscarriage was complete. Supplementary information and data for women who did not return their questionnaire were retrieved from medical records. RESULTS: Of 94 women randomized to misoprostol treatment and 95 allocated to expectant management, 94 and 90 women, respectively, were included for analysis. Information on reproductive outcome was available for 89/94 (95%) and 83/90 (92%) women, respectively. Complete miscarriage without surgical evacuation was achieved within 31 days in 85% (76/89) of the women in the misoprostol group and in 65% (54/83) of those managed expectantly. The proportion of women treated with surgical evacuation was 33% (27/83) in the expectant-management group vs 12% (11/89) in the misoprostol group. At 14 months after the index miscarriage was complete, 75% (67/89) of women treated with misoprostol and 75% (62/83) of those managed expectantly had achieved at least one clinical pregnancy, while 40% (36/89) and 35% (29/83), respectively, had had at least one live birth (mean difference, 5.5% (95% CI, -9.7 to 20.3%)). When considering the outcome of all pregnancies conceived within 14 months after the index miscarriage was complete, 63% (56/89) of women in the misoprostol group and 55% (46/83) of those in the expectant-management group delivered a live baby after a pregnancy (mean difference, 7.5% (95% CI, -7.9 to 22.4%)). CONCLUSION: Women with early miscarriage can be reassured that fertility is similar after misoprostol treatment and expectant management. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortion, Spontaneous/therapy , Misoprostol/administration & dosage , Reproduction , Uterine Hemorrhage/therapy , Watchful Waiting/statistics & numerical data , Administration, Intravaginal , Adult , Birth Intervals , Female , Humans , Pregnancy , Prospective Studies , Randomized Controlled Trials as Topic , Reproductive History , Treatment Outcome
8.
Pan Afr Med J ; 38: 17, 2021.
Article in English | MEDLINE | ID: mdl-34567344

ABSTRACT

Methotrexate (MTX) is an effective, economical and safe drug used in the treatment of ectopic pregnancy. Complications are very rare. Herein, we reported a case of febrile neutropenia following single low-dose methotrexate for the treatment of ectopic pregnancy. Febrile neutropenia developed on day 4 of single-dose methotrexate administered intramuscularly. Although methotrexate single-dose regimen is quite effective and safe in ectopic pregnancy, febrile neutropenia can occur very rarely.


Subject(s)
Abortifacient Agents, Nonsteroidal/adverse effects , Febrile Neutropenia/chemically induced , Methotrexate/adverse effects , Abortifacient Agents, Nonsteroidal/administration & dosage , Adult , Female , Humans , Injections, Intramuscular , Methotrexate/administration & dosage , Pregnancy , Pregnancy, Ectopic/drug therapy
9.
Acta Obstet Gynecol Scand ; 100(11): 2076-2081, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34467531

ABSTRACT

INTRODUCTION: Missed abortion can be treated with medication or aspiration curettage. A Karman aspiration cannula is another option. We evaluated its success in evacuating retained products of conception (RPOC) based on symptoms, endometrial thickness, endometrial irregularity, and blood flow seen on Doppler ultrasound (indicative of placenta). MATERIAL AND METHODS: This prospective, randomized, nonblinded trial was conducted in a university-affiliated medical center. It included 40 women diagnosed with missed abortion and two failed courses of 600 µg buccal misoprostol, one  week apart, randomly assigned to treatment or controls. One week after the second misoprostol course, immediately after evaluating endometrial thickness, endometrial irregularity using Doppler ultrasound, and with blood flow indicative of RPOC, women in the aspiration group underwent endometrial suction with a Karman aspiration cannula. The 5-6 mm cannula attached to a 60 mL syringe was inserted into the uterus under ultrasound guidance. The contents were aspirated until the uterus was empty. Control group patients did not receive additional treatment. All were scheduled for ambulatory, operative hysteroscopy under anesthesia 1 month later (departmental protocol). On that day, all women with RPOC on Doppler ultrasound underwent hysteroscopy. Bleeding days, days with pain, pain according to visual analog scale, length of hospitalization, and infection rate were recorded. NIH clinical trial registration number NCT02917785. RESULTS: In the study group, 90% did not need hysteroscopy, compared with 50% of controls (p = 0.014). No complications were noted. At all visits, we used Doppler ultrasound to exclude or confirm RPOC. Pathology revealed RPOC in all women who underwent aspiration. Average visual analog scale score for office aspiration (n = 20) was 4.9 ± 3.6. vs. 6.3 ± 3.4 for the first (p = 0.157) and 4.7 ± 3.3 for the second (p = 0.836) misoprostol treatment cycle. The treatment group experienced 6.1 days of bleeding and the control group experienced 1.4 days (p = .006). CONCLUSIONS: Based on our criteria of diagnosing RPOC according to symptoms, endometrial thickness, endometrial irregularity, and blood flow indicative of placental tissue seen on Doppler ultrasound and histo-pathological confirmation, aspiration using Karman cannula can be an effective therapeutic approach. It may be a safe alternative for women with RPOC after misoprostol failure.


Subject(s)
Abortion, Missed/therapy , Placenta, Retained/therapy , Vacuum Curettage , Abortifacient Agents, Nonsteroidal/administration & dosage , Adolescent , Adult , Female , Humans , Misoprostol/administration & dosage , Pregnancy , Prospective Studies
10.
JAMA ; 326(5): 390-400, 2021 08 03.
Article in English | MEDLINE | ID: mdl-34342619

ABSTRACT

Importance: Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities. Objective: To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. Design, Setting, and Participants: This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019). Interventions: Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). Main Outcomes and Measures: The primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of -12%. Results: Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, -8.4% to ∞]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%). Conclusions and Relevance: Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results. Trial Registration: ClinicalTrials.gov Identifier: NCT02152696.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Methotrexate/administration & dosage , Pregnancy, Ectopic/drug therapy , Pregnancy, Ectopic/surgery , Watchful Waiting , Abortion, Spontaneous , Adult , Chorionic Gonadotropin/blood , Combined Modality Therapy , Dilatation and Curettage , Female , Humans , Patient Satisfaction , Pregnancy , Ultrasonography, Prenatal , Uterine Hemorrhage
11.
Eur Rev Med Pharmacol Sci ; 25(12): 4190-4197, 2021 Jun.
Article in English | MEDLINE | ID: mdl-34227085

ABSTRACT

OBJECTIVE: Cervical ectopic pregnancy (CEP) is a rare obstetric complication but carries the risk of life-threatening maternal hemorrhage. CASE PRESENTATION: A 43-year-old nulliparous woman, presented to the Emergency Room with vaginal bleeding. Initial quantitative serum ß-hCG value was 85,220 mIU/mL. Obstetrical ultrasound demonstrated a single, live pregnancy of approximately 9 weeks' gestation located within the endocervix. After discussing different management options, intramuscular methotrexate injection in association with intra-amniotic chloride potassium installation was decided in order to preserve patient's desire for childbearing. Three months later, the patient was readmitted due to a massive vaginal bleeding. Angiographic uterine artery embolization (UAE) with an absorbable gelatin sponge was performed. After the procedure and two days of hospitalization, no significative bleeding was observed. The clinical course was uneventful, and serum human chorionic gonadotropin decreased immediately. The cervical mass gradually shrank and disappeared a month after UAE. CONCLUSIONS: To preserve fertility in the management of CEP, clinicians could consider a combination of strategies, including UAE. A review of the current literature and possible treatment options for conservative CEP management are analyzed and discussed.


Subject(s)
Abortifacient Agents, Nonsteroidal/therapeutic use , Fertility Preservation , Methotrexate/therapeutic use , Pregnancy, Ectopic/drug therapy , Abortifacient Agents, Nonsteroidal/administration & dosage , Adult , Female , Humans , Injections, Intramuscular , Methotrexate/administration & dosage , Pregnancy , Pregnancy, Ectopic/diagnosis
12.
Fertil Steril ; 116(5): 1417-1419, 2021 11.
Article in English | MEDLINE | ID: mdl-34289934

ABSTRACT

OBJECTIVE: To describe a conservative cesarean scar pregnancy (CSP) treatment in a patient with the desire for future pregnancy. To date, there is no gold standard for the management of a viable CSP. There is a wide range of treatment options that include major surgery and minimally invasive procedures. Moreover, after a minimally invasive treatment, the gestational sac may be visible at ultrasound for >6 months. The described technique may be useful to avoid complications related to the use of energy with a large reduction in operative times. DESIGN: Description of the technique with narrated video footage. SETTING: Academic tertiary hospital. PATIENT(S): A 31-year-old woman with a previous cesarean section was referred to our clinic with lower abdominal pain. Transvaginal ultrasound revealed a gestational sac with a viable embryo located in the anterior isthmic region, suggestive of CSP at 9 weeks of gestation. Appropriate counseling describing the two diametrically opposite clinical management options was performed, and the patient decided to terminate the pregnancy. Informed consent was obtained from the patient. INTERVENTION(S): Hysteroscopy was performed under local anesthesia in an outpatient setting, using a 2.9-mm Hopkins II Forward-Oblique Telescope 30° endoscope (Karl Storz, Tuttlingen, Germany) with a 4.3-mm inner sheath and 5F instruments. A 3.7F needle (Deflux metal needle; Oceana Therapeutics, Edison, NJ) was pushed into the myometrial tissue surrounding the implantation site of the gestational sac at four different points. Six additional injections were performed into the gestational sac, and 50-mg methotrexate was injected. The appropriate follow-up was performed to determine the success of the procedure. ß-Human chorionic gonadotropin was dosed weekly until negative. After 6 weeks, to remove the avascular trophoblastic remnants found at ultrasound evaluation, the patient underwent hysteroscopic removal with a 6-mm TruClear hysteroscopic tissue removal system (Medtronic Parkway, Minneapolis, MN). A contemporary transabdominal ultrasound was performed to minimize surgical risks. MAIN OUTCOME MEASURE(S): Complete and conservative CSP treatment with the absence of surgical complications. RESULT(S): Conservative cesarean scar pregnancy treatment was performed successfully with primary local methotrexate injection followed, after 6 weeks, by hysteroscopic removal of the CSP remnants with the TruClear hysteroscopic tissue removal system. The first procedure lasted 6 minutes, whereas hysteroscopic removal of the CSP lasted 5 minutes. Both procedures were performed in an outpatient setting, and no complications were detected during and after the treatments. The patient reported good health at the 1-month follow-up visit, and the ultrasound showed an empty isthmocele (Fig. 1). CONCLUSION(S): Primary local methotrexate injection followed by hysteroscopic removal of the CSP remnants with the hysteroscopic tissue removal system may be a valuable treatment for women who desire pregnancy in the near future. This combined technique may avoid potential complications, such as thermal-induced myometrial injuries or uterine perforation. Moreover, the operator has the possibility to perform an under-vision procedure with a lower incidence of intraoperative and postoperative bleeding. Because it does not reduce fertility/pregnancy rate, this technique should be a valid option in patients who desire future pregnancy.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Cesarean Section/adverse effects , Cicatrix/etiology , Hysteroscopy , Methotrexate/administration & dosage , Pregnancy, Ectopic/therapy , Abdominal Pain/etiology , Adult , Combined Modality Therapy , Female , Humans , Injections , Pregnancy , Pregnancy, Ectopic/diagnostic imaging , Pregnancy, Ectopic/etiology , Treatment Outcome
13.
BJOG ; 128(11): 1752-1761, 2021 10.
Article in English | MEDLINE | ID: mdl-34138505

ABSTRACT

OBJECTIVE: To explore the experiences of women in Scotland who accessed medical abortion at home up to 12 weeks' gestation, delivered via a telemedicine abortion service implemented in response to the coronavirus (COVID-19) pandemic, to identify areas for improvement and inform service provision. DESIGN: Qualitative interview study. SETTING: Abortion service in one National Health Service health board in Scotland. POPULATION OR SAMPLE: Twenty women who accessed telemedicine abortion services and self-administered mifepristone and misoprostol at home up to 12 weeks' gestation. METHODS: Thematic analysis of semi-structured qualitative interviews, informed by the Framework analytic approach. MAIN OUTCOME MEASURES: Women's experiences of accessing telemedicine for medical abortion at home, specifically: acceptability of the telephone consultation and remote support; views on no pre-abortion ultrasound scan; and self-administration of abortion medications at home. RESULTS: Novel study findings were three-fold: (1) participants valued the option of accessing abortion care via telemedicine and emphasised the benefits of providing a choice of telephone and in-person consultation to suit those with different life circumstances; (2) the quality of abortion care was enhanced by the telemedicine service in relation to access, comfort and flexibility, and ongoing telephone support; (3) participants described being comfortable with, and in some cases a preference for, not having an ultrasound scan. CONCLUSIONS: This research demonstrates support for the continuation of telemedicine abortion services beyond the temporary arrangements in place during COVID-19, and lends weight to the argument that offering the option of telemedicine abortion care can enable women to access this essential health service. TWEETABLE ABSTRACT: #Telemedicine provision of medical #abortion at home up to 12 weeks' gestation is acceptable and highly valued by #women #Research #SRHR @nbw80 @doctorjjrw @jeniharden @cameronsharon @mrc_crh @edinuniusher.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortion, Induced/methods , Patient Satisfaction , Self Administration/psychology , Telemedicine/methods , Abortion, Induced/psychology , Adult , COVID-19 , Female , Health Services Accessibility , Humans , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Pregnancy , Qualitative Research , SARS-CoV-2 , Scotland , State Medicine
15.
J Gynecol Obstet Hum Reprod ; 50(9): 102180, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34107357

ABSTRACT

INTRODUCTION: Adherence to follow-up is an important consideration when treating non-emergent ectopic pregnancy. Our aim was to evaluate the management of ectopic pregnancy among patients in a public hospital system and to identify factors related to adherence of medical management in this population. MATERIAL AND METHODS: A retrospective review to evaluate the management of ectopic pregnancy among women in a public hospital system, including all women undergoing treatment for ectopic pregnancy from 2012 to 2017. Data were abstracted from the medical record. Women who were adherent to follow-up were compared to those who were non-adherent. Log-binomial regression was used to identify factors associated with management type and adherence to follow-up of medical management. RESULTS: Of 283 women diagnosed with an ectopic pregnancy, 182 (64.3%) were managed surgically and 101 (35.7%) were managed with methotrexate. Among non-emergent cases, presence of fetal cardiac activity, human chorionic gonadotropin (HCG) level ≥5000mIU/mL, ectopic size ≥3.5 cm, and multigravid status was associated with surgical management. Among patients receiving methotrexate, 66 (65.3%) adhered to required lab draws 4 and 7 days following methotrexate administration (+/-1 day). Among those receiving methotrexate 45.5% (n = 46) were lost to follow-up. Lower prevalence of adherence to follow-up (i.e. lab draws completed until pregnancy levels were negative) was observed among non-Hispanic African American (RR=0.64, 95%CI 0.45-0.94) compared to white women and women with multigravid status (RR=0.67, 95%CI 0.48-0.95) after adjustment. CONCLUSIONS: Nearly half of those treated with methotrexate failed to complete follow-up. African-American women and multigravida women were at higher risk of being lost to follow up.


Subject(s)
Gynecologic Surgical Procedures/methods , Methotrexate/administration & dosage , Patient Compliance , Pregnancy, Ectopic/drug therapy , Pregnancy, Ectopic/surgery , Abortifacient Agents, Nonsteroidal/administration & dosage , Adolescent , Adult , Cohort Studies , Female , Hospitals, Public , Humans , Middle Aged , Pregnancy , Retrospective Studies , Young Adult
16.
JAMA Netw Open ; 4(5): e2111852, 2021 05 03.
Article in English | MEDLINE | ID: mdl-34019085

ABSTRACT

Importance: People in the US have been seeking self-managed abortions outside the formal health care system using medications obtained through online telemedicine. However, little is known about this practice, including potential motivating factors. Objective: To examine individual reasons for accessing medication abortion through an online telemedicine service as well as associations between state- and county-level factors and the rate of requests. Design, Setting, and Participants: This population-based cross-sectional study examined all requests for self-managed medication abortion through an online consultation form available from Aid Access, a telemedicine service in the US, between March 20, 2018, and March 20, 2020. Main Outcomes and Measures: Individual-level reasons for accessing the telemedicine service were examined as well as the rate of requests per 100 000 women of reproductive age by state. Zip code data provided by individuals making requests were used to examine county-level factors hypothesized to be associated with increased demand for self-managed abortion: distance to a clinic (calculated using location data for US abortion clinics) and the population proportion identifying as a member of a racial/ethnic minority group, living below the federal poverty level, and having broadband internet access (calculated using census data). Results: During the 2-year study period, 57 506 individuals in 2458 counties in 50 states requested self-managed medication abortion; 52.1% were aged 20 to 29 years (mean [SD] age, 25.9 [6.7] years), 50.0% had children, and 99.9% were 10 weeks' pregnant or less. The most common reasons cited by individuals making requests were the inability to afford in-clinic care (73.5%), privacy (49.3%), and clinic distance (40.4%). States with the highest rate of requests were Louisiana (202.7 per 100 000 women) and Mississippi (199.9 per 100 000 women). At the county level, an increase of 1 SD (47 miles) in distance to the nearest clinic was significantly associated with a 41% increase in requests (incidence rate ratio, 1.41; 95% CI, 1.31-1.51; P < .001), and a 10% increase in the population living below the federal poverty level was significantly associated with a 20% increase in requests (incidence rate ratio, 1.20; 95% CI, 1.13-1.28; P < .001). Conclusions and Relevance: In this cross-sectional study, clinic access barriers were the most commonly cited reason for requesting self-managed medication abortion using an online telemedicine service. At the county level, distance to an abortion clinic and living below the federal poverty level were associated with a higher rate of requests. State and federal legislation could address these access barriers.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Steroidal/administration & dosage , Abortion, Induced/methods , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Self-Management/methods , Self-Management/statistics & numerical data , Telemedicine/statistics & numerical data , Adolescent , Adult , Cross-Sectional Studies , Female , Humans , Middle Aged , Pregnancy , Young Adult
17.
Am Fam Physician ; 103(8): 473-480, 2021 04 15.
Article in English | MEDLINE | ID: mdl-33856168

ABSTRACT

Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days' gestation and for medication abortion up to 77 days' gestation. Gestational age is determined using ultrasonography or menstrual history. Ultrasonography is needed when gestational dating cannot be confirmed using clinical data alone or when there are risk factors for ectopic pregnancy. The most effective regimens for medication management of early pregnancy loss and medication abortion include 200 mg of oral mifepristone (a progesterone receptor antagonist) followed by 800 mcg of misoprostol (a prostaglandin E1 analogue) administered buccally or vaginally. Cramping and bleeding are expected effects of the medications, with bleeding lasting an average of nine to 16 days. The adverse effects of misoprostol (e.g., low-grade fever, gastrointestinal symptoms) can be managed with nonsteroidal anti-inflammatory drugs or antiemetics. Ongoing pregnancy, infection, hemorrhage, undiagnosed ectopic pregnancy, and the need for unplanned uterine aspiration are rare complications. Clinical history, combined with serial quantitative beta human chorionic gonadotropin levels, urine pregnancy testing, or ultrasonography, is used to establish complete passage of the pregnancy tissue.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Abortifacient Agents, Nonsteroidal/adverse effects , Abortion, Induced , Abortion, Spontaneous , Female , Humans , Mifepristone/adverse effects , Misoprostol/adverse effects , Pregnancy , Prenatal Care
18.
Cancer Chemother Pharmacol ; 87(6): 807-815, 2021 06.
Article in English | MEDLINE | ID: mdl-33677616

ABSTRACT

PURPOSE: High dose methotrexate (HDMTX) acute kidney injury (AKI) results in prolonged hospitalization and treatment delays. Using a pharmacologically-based approach, HDMTX was administered with standard combination therapy to patients with osteosarcoma; nephrotoxicity was assessed. METHODS: Patients were randomized by cycle to 4 h or 12 h HDMTX (12 g/m2) infusions administered with hydration, alkalization and leucovorin rescue. Urinalysis, AKI biomarkers, and estimated glomerular filtration rate using serum creatinine or cystatin C (GFRCr or GFRcysC) were obtained. Serum and urine methotrexate concentrations [MTX] were measured. RESULTS: Patients (n = 12), median (range) age 12.4 (5.7-19.2) years were enrolled; 73 MTX infusions were analyzed. Median (95% Confidence Interval) serum and urine [MTX] were 1309 (1190, 1400) µM and 16.4 (14.7, 19.4) mM at the end of 4 h infusion and 557 (493, 586) µM and 11.1 (9.9, 21.1) mM at the end of 12 h infusion. Time to serum [MTX] < 0.1 µM was 83 (80.7, 90.7) h and 87 (82.8, 92.4) h for 4 and 12 h infusions. GFRCr was highly variable, increased after cisplatin, and exceeded 150 ml/min/1.73 m2. GFRcysC was less variable and decreased at the end of therapy. AKI biomarkers were elevated indicating acute tubular dysfunction, however, did not differ between 4 and 12 h infusions. Radiographic and histological response were similar for patients receiving 4 h or 12 h infusions; the median percent tumor necrosis was > 95%. CONCLUSIONS: Reducing peak serum and urine MTX concentration by prolonging the infusion duration did not alter risk of acute kidney injury. GFRcysC was decreased at the end of therapy. Proteinuria and elevations in AKI biomarkers indicate that direct tubular damage contributes to HDMTX nephrotoxicity. CLINICAL TRIAL: NCT01848457.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Nonsteroidal/adverse effects , Acute Kidney Injury/chemically induced , Biomarkers/metabolism , Methotrexate/administration & dosage , Methotrexate/adverse effects , Osteosarcoma/drug therapy , Acute Kidney Injury/metabolism , Adolescent , Adult , Child , Child, Preschool , Female , Humans , Male , Osteosarcoma/metabolism , Young Adult
19.
Eur J Contracept Reprod Health Care ; 26(2): 171-173, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33615941

ABSTRACT

In the second trimester, medical abortion is preferred as it is less invasive, and the surgical method carries more risk. There is a paucity of published literature on medical abortion in women with renal failure requiring haemodialysis. We came across a woman who presented with rapidly progressive renal failure at 18 weeks of gestation and required therapeutic abortion. We are reporting the challenges, outcomes, and precautions to be taken while performing a medical abortion in such a case.


Subject(s)
Abortifacient Agents, Nonsteroidal/therapeutic use , Abortifacient Agents, Steroidal/therapeutic use , Abortion, Induced , Lupus Nephritis/complications , Mifepristone/therapeutic use , Misoprostol/therapeutic use , Renal Insufficiency/complications , Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Steroidal/administration & dosage , Female , Humans , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Pregnancy , Pregnancy Trimester, Second , Treatment Outcome
20.
J Gynecol Obstet Hum Reprod ; 50(5): 102073, 2021 May.
Article in English | MEDLINE | ID: mdl-33513454

ABSTRACT

Ectopic pregnancy is a frequent and life-threatening risk of childbearing. Its management represents a mainstay of emergency gynecological surgery, and laparoscopy is the surgical gold standard technique. The technique of transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) for the management of ectopic pregnancy is presented herein. The procedure is illustrated by an instructive video article that standardizes the essential steps to make the technique ergonomic and easy to perform (step-by-step explanations). This surgical technique allows to consider vaginal salpingectomy using a combined cœlio-vaginal approach. After a posterior colpotomy, an Alexis retractor was inserted in the pouch of Douglas followed by the placement of a dedicated platform on which three trocars were fixed. Pneumoperitoneum was then achieved. Once the diagnosis of ruptured tubal ectopic pregnancy was established, a salpingectomy was performed. As a minimally invasive approach, this procedure has high patient acceptance and seems to improve favorable clinical outcomes.


Subject(s)
Natural Orifice Endoscopic Surgery/methods , Pregnancy, Tubal/surgery , Salpingectomy/methods , Abortifacient Agents, Nonsteroidal/administration & dosage , Female , Humans , Methotrexate/administration & dosage , Pregnancy , Pregnancy, Tubal/diagnostic imaging , Vagina , Young Adult
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