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Obstetrics and Gynecology Jan 2020To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone.
METHODS
We planned to enroll 40 patients in a double-blind, placebo-controlled, randomized trial. We enrolled patients at 44-63 days of gestation with ultrasound-confirmed gestational cardiac activity who were planning surgical abortion. Participants ingested mifepristone 200 mg and initiated oral progesterone 400 mg or placebo 24 hours later twice daily for 3 days, then once daily until their planned surgical abortion 14-16 days after enrollment. Follow-up visits were scheduled 3±1, 7±1, and 15±1 days after mifepristone intake with ultrasonography and blood testing for human chorionic gonadotropin and progesterone. Participants exited from the study when they had their surgical abortion or earlier for gestational cardiac activity absence, gestational sac expulsion, or medically indicated suction aspiration. We assessed the primary outcome of continued gestational cardiac activity at approximately 2 weeks (15±1 day), side effects after drug ingestion, and safety outcomes including hemorrhage and emergent treatment.
RESULTS
We enrolled participants from February to July 2019 and stopped enrollment after 12 patients for safety concerns. Mean gestational age was 52.5 days. Two (one per group) voluntarily discontinued 3 days after mifepristone ingestion for subjective symptoms (nausea and vomiting, bleeding). Among the remaining 10 patients (five per group), gestational cardiac activity continued for 2 weeks in four in the progesterone group and two in the placebo group. One patient in the placebo group had no gestational cardiac activity 3 days after mifepristone use. Severe hemorrhage requiring ambulance transport to hospital occurred in three patients; one received progesterone (complete expulsion, no aspiration) and two received placebo (aspiration for both, one required transfusion). We halted enrollment after the third hemorrhage. No other significant side effects were reported.
CONCLUSION
We could not estimate the efficacy of progesterone for mifepristone antagonization due to safety concerns when mifepristone is administered without subsequent prostaglandin analogue treatment. Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03774745.
Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Oral; Adult; California; Chorionic Gonadotropin; Double-Blind Method; Female; Gestational Age; Humans; Mifepristone; Pregnancy; Progesterone; Uterine Hemorrhage; Vacuum Curettage; Young Adult
PubMed: 31809439
DOI: 10.1097/AOG.0000000000003620 -
Revista Colombiana de Obstetricia Y... Mar 2022Objectives: To characterize a cohort of women with voluntary interruption of pregnancy (VIP) and to describe intraoperative complications according to the technique...
Objectives: To characterize a cohort of women with voluntary interruption of pregnancy (VIP) and to describe intraoperative complications according to the technique used. Materials and Methods: Descriptive study in a historical cohort of women undergoing VIP in two healthcare institutions in Medellín, Colombia, in 2019. Women with pelvic infection and STIs were excluded. Consecutive sampling was used. Sociodemographic, sexual and reproductive health, clinical characteristics of the pregnancy, legal cause of the VIP, characteristics of the care process and complications of the VIP techniques up to post-procedural day 7 were the measured variables. A descriptive analysis was carried out. Results: Overall, 1,520 women were identified as eligible during the study period. Of them, 46 were intervened in other institutions, leaving 1,474 candidates to enter the study. Of them, 30 were excluded because of pelvic or sexually transmitted infections. Ultimately, 1,444 pregnant women were included in the analysis. Risk to the mother’s health was the most frequent legal cause in 94.3% of cases. Ninety-nine percent of women received pre-procedural counseling, and 78.4% agreed to use some form of contraception after VIP. Manual vacuum aspiration (MVA) was used in 95.6% of women and dilation and curettage (D&C) in 4.4%. Complications up to postoperative day 7 occurred in 17.56%, and there were no complications in the MVA group; 80% of women attended the follow-up visit on post-VIP day 7. Conclusions: MVA is a safe procedure which was not associated with complications within the first seven post-VIP days in the studied patients. Prospective studies to assess the safety and cost of the different VIP options are required.
PubMed: 35503301
DOI: 10.18597/rcog.3760 -
European Journal of Obstetrics,... Mar 2021The study aims to evaluate the success rate of suction curettage (SC) as a first line treatment with or without use of foley balloon tamponade for cesarean scar...
OBJECTIVES
The study aims to evaluate the success rate of suction curettage (SC) as a first line treatment with or without use of foley balloon tamponade for cesarean scar pregnancy (CSP) and to determine the risk factors for failure of treatment.
STUDY DESIGN
The study was retrospective and included 36 CSP cases who underwent SC for treatment. Presence of pain with active bleeding and > 10 weeks of gestation were taken as the exclusion criterion. The procedure was performed under sonographic guidance. After the procedure, in patients who had a hemorrhage foley catheter was inserted into the uterine cavity. SC failure was defined as a requirement of secondary intervention. CSP types, myometrial thickness in the scar area, fetal cardiac activity, initial Beta human chorionic gonadotropin levels (β-HCG), history of vaginal delivery were compared between successful and failed groups.
RESULT
Of 36 patients, 31 had favorable results with SC ± foley balloon tamponade. Success rate was found to be 86 % (31/36) as the first line therapy. Foley catheter was applied for 23 patients, among them, four were in the failed group and 19 were in the favorable group. In the failed group, two patients had emergent laparotomy, two had repeat SC the day after the initial treatment and one patient was treated with systemic MTX. Fetal cardiac activity and presence of embryonic pole were not different between the groups (p = 1.000, p = 0.829 respectively). Myometrial thickness in the failed group was less than the successful group, this difference was significant (p = 0.033). CSP types, initial β-HCG levels and history of vaginal delivery were not different between the groups (p = 0.149, p = 0.372 and p = 0.404 respectively).
CONCLUSION
SC may be considered as a first line therapy for CSPs, and and in patients complicated with hemorrhage foley balloon tamponade can be used easily. Thinner myometrium at previous cesarean scar can be considered as a risk factor for failure of SC in patients with CSP.
Topics: Cesarean Section; Chorionic Gonadotropin, beta Subunit, Human; Cicatrix; Female; Humans; Pregnancy; Retrospective Studies; Vacuum Curettage
PubMed: 33450710
DOI: 10.1016/j.ejogrb.2021.01.002 -
Journal of Medical Case Reports Jul 2022Urothelial carcinoma of the bladder accounts for nearly 90% of all bladder cancers. Risk factors include cigarette smoke, chronic cystitis, and human papilloma virus... (Review)
Review
BACKGROUND
Urothelial carcinoma of the bladder accounts for nearly 90% of all bladder cancers. Risk factors include cigarette smoke, chronic cystitis, and human papilloma virus infection. It is commonly diagnosed by hematuria, obstructive voiding, and irritative symptoms. Despite the prevalence of urothelial carcinoma, elevation of β-human chorionic gonadotropin in the setting of these malignancies is not common. This case report informs gynecologic practitioners to consider urologic causes of β-human chorionic gonadotropin elevation even in the setting of recent spontaneous abortion and details comprehensive review of diagnostic testing in the setting of β-human chorionic gonadotropin elevation.
CASE PRESENTATION
A 49-year-old, non-Hispanic Caucasian woman, former smoker, with a history of polycystic ovary syndrome, high-risk human chorionic gonadotropin infection, and hypertension, underwent vacuum-assisted aspiration for significant vaginal bleeding in the setting of incomplete abortion. Fetal tissue was confirmed pathologically. Human chorionic gonadotropin levels decreased to 12.5 mU/mL and were no longer followed due to resumption of menses. Five months later during routine preoperative evaluation for orthopedic surgery, her human chorionic gonadotropin level was found to be elevated. She was also noted to have persistent asymptomatic hematuria. She completed an extensive gynecologic and urologic work-up, including hysteroscopy, dilation and curettage, methotrexate therapy, computerized tomographic imaging, and cystoscopy to finally arrive at the diagnosis of urothelial carcinoma.
CONCLUSIONS
Only a rare subset of urothelial carcinomas secretes β-human chorionic gonadotropin. Therefore, diagnosis of urothelial carcinoma is typically achieved by urine cytology with cystoscopic biopsy. Although rare, urothelial carcinoma should be considered in patients with risk factors presenting with persistently elevated beta-human chorionic gonadotropin.
Topics: Abortion, Spontaneous; Carcinoma, Transitional Cell; Chorionic Gonadotropin; Chorionic Gonadotropin, beta Subunit, Human; Female; Hematuria; Humans; Middle Aged; Pregnancy; Urinary Bladder Neoplasms
PubMed: 35842706
DOI: 10.1186/s13256-022-03511-7 -
Journal of Gynecology Obstetrics and... Feb 2023There is still no consensus on a safe and efficient treatment modality for cesarean scar pregnancy (CSP), which is known to cause severe complications, such as...
OBJECTIVE
There is still no consensus on a safe and efficient treatment modality for cesarean scar pregnancy (CSP), which is known to cause severe complications, such as life-threatening hemorrhage. Suction curettage (SC) has been used as the first-line treatment for CSP with controversial outcomes. In this context, the objective of this study is to analyze the efficacy of SC in the treatment of CSP.
METHODS
The sample of this retrospective study consisted of 64 CSP patients treated using SC between 2012 and 2022. Patients' demographic and clinical variables, including the thickness of the myometrium at the lower uterine segment between the urinary bladder and cesarean scar, were obtained from their medical records. The study's primary outcome was determined as the success rate of SC. Accordingly, the patients were categorized into two groups: successful SC (Group 1) and unsuccessful SC (Group 2).
RESULTS
The success rate of SC was determined as 78.1%. The number of previous cesarean deliveries, gestational age, baseline beta-human chorionic gonadotropin (β-hCG) values, and endometrial thickness was significantly higher in Group 2 (p<0.05 for all), whereas the fetal cardiac activity and absence of an embryonic pole were significantly higher in Group 2 (p = 0.001 and p = 0.004, respectively). There was no significant difference between the groups in the thickness of the myometrium at the lower uterine segment (p = 0.890). The hemoglobin levels decreased significantly after SC in both Groups 1 and 2 (p<0.001 and p = 0.009, respectively). There was no significant difference between the groups in preoperative and postoperative hemoglobin values and the decrease in hemoglobin levels (p>0.05).
CONCLUSION
The study findings did not indicate any significant correlation between myometrial thickness at the lower uterine segment and the efficacy of SC in CSP patients. On the other hand, the number of cesarean deliveries, gestational age, baseline β-hCG values, endometrium thickness, fetal cardiac activity, and embryonic pole may be used to predict the outcome of SC in the treatment of CSP.
Topics: Pregnancy; Female; Humans; Vacuum Curettage; Retrospective Studies; Cicatrix; Pregnancy, Ectopic; Chorionic Gonadotropin, beta Subunit, Human
PubMed: 36592889
DOI: 10.1016/j.jogoh.2022.102531 -
Clinical Obstetrics and Gynecology Sep 2021Access to first trimester abortions has increased significantly in the past few decades in low and middle-income countries. Manual vacuum aspiration is now standard of...
Access to first trimester abortions has increased significantly in the past few decades in low and middle-income countries. Manual vacuum aspiration is now standard of care for procedural abortion and postabortion care. Medication abortion has shifted abortions to being performed earlier in pregnancy and is becoming more widely available with new service delivery strategies to broaden access. Widespread availability of misoprostol has made abortions induced outside of the formal medical sector overall safer. In both legally restrictive and supportive environments, there is increased interested in self-managed abortions as part of a shift towards demedicalizing abortion through task-sharing.
Topics: Abortion, Induced; Developing Countries; Female; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, First; Vacuum Curettage
PubMed: 34323227
DOI: 10.1097/GRF.0000000000000626 -
International Journal of Gynecological... Sep 2021
Topics: Female; Humans; Hydatidiform Mole; Pregnancy; Vacuum Curettage
PubMed: 34049976
DOI: 10.1136/ijgc-2021-002631 -
Frontiers in Surgery 2023This study aims to evaluate the importance of the gestational age at diagnosis and the types of cesarean scar pregnancy (CSP) for treatment outcomes and to identify the...
OBJECTIVE
This study aims to evaluate the importance of the gestational age at diagnosis and the types of cesarean scar pregnancy (CSP) for treatment outcomes and to identify the optimal treatment based on both the gestational age at diagnosis and the CSP type.
METHODS
A retrospective cohort study included 223 pregnant women diagnosed with CSP at Peking University First Hospital, Beijing, China, between 2014 and 2018. All CSP cases underwent ultrasound-guided vacuum aspiration followed by supplementary curettage. Adjuvant treatment modalities included intramuscular injection of systemic methotrexate, uterine artery embolization, and hysteroscopy before ultrasound-guided vacuum aspiration. Linear regression was used to determine the relationship between intraoperative blood loss and gestational age at diagnosis, CSP type, highest β-human chorionic gonadotropin level, and management procedures.
RESULTS
None of the patients required blood transfusions or hysterectomies. Patients presenting at <8, 8-10, and >10 weeks had median estimated blood loss of 5, 10, and 35 ml, respectively. Patients with type I CSP, type II CSP, and type III CSP had median blood loss of 5, 5 and 10 ml, respectively. Multivariate linear regression analysis demonstrated that the gestational age at diagnosis ( < 0.001) and type of CSP ( = 0.023) were independent predictors of intraoperative estimated blood loss. For type I CSP patients, ultrasound-guided vacuum aspiration followed by supplementary curettage alone was performed in 15 of 34 (44.1%) patients, including 12/27 (44.4%) diagnosed at <8 weeks, 2/6 (33.3%) at 8-10 weeks, and 1/1 for >10 weeks. In type II CSP patients, fewer cases were managed by ultrasound-guided vacuum aspiration followed by supplementary curettage alone as the gestational age at diagnosis increased [18/96 (18.8%) for <8 weeks, 7/41 (17.1%) for 8-10 weeks, none for >10 weeks]. Most type III CSP patients (41/45, 91.1%) needed treatments in addition to the ultrasound-guided vacuum aspiration regardless of the gestational age at diagnosis. All CSP patients were treated successfully and did not require readmission or further medical interventions.
CONCLUSION
Gestational age at diagnosis of CSP and its type show a strong correlation with estimated blood loss during ultrasound-guided vacuum aspiration. With careful management, CSPs may be treated at any gestational week, regardless of their type, with minimal intraoperative bleeding.
PubMed: 36874460
DOI: 10.3389/fsurg.2023.1055245 -
PloS One 2023Approximately one in four women will experience a miscarriage in their lifetime. Ultrasound-guided manual vacuum aspiration (USG-MVA) is an ideal outpatient surgical...
BACKGROUND AND AIM
Approximately one in four women will experience a miscarriage in their lifetime. Ultrasound-guided manual vacuum aspiration (USG-MVA) is an ideal outpatient surgical treatment alternative to traditional surgical evacuation. We aimed to examine the cost-effectiveness of US-MVA with cervical preparation for treatment of early pregnancy loss from the perspective of public healthcare provider of Hong Kong.
METHODS
A decision-analytic model was designed to simulate outcomes in a hypothetical cohort of patients with early pregnancy loss on four interventions: (1) US-MVA, (2) misoprostol, (3) surgical evacuation of uterus by dilation and curettage (surgical evacuation), and (4) expectant care. Model inputs were retrieved from published literature and public data. Model outcome measures were total direct medical cost and disutility-adjusted life-year (DALY). Base-case model results were examined by sensitivity analysis.
RESULTS
The expected DALYs (0.00141) and total direct medical cost (USD736) of US-MVA were the lowest of all interventions in base-case analysis, and US-MVA was the preferred cost-effective option. One-way sensitivity analysis showed that the misoprostol group became less costly than the US-MVA group if the evacuation rate of misoprostol (base-case value 0.832) exceeded 0.920. In probabilistic sensitivity analysis, At the willingness-to-pay (WTP) threshold of 49630 USD/DALY averted (1x gross domestic product per capita of Hong Kong), the US-MVA was cost-effective in 72.9% of the time.
CONCLUSIONS
US-MVA appeared to be cost-saving and effective for treatment of early pregnancy loss from the perspective of public healthcare provider of Hong Kong.
Topics: Pregnancy; Female; Humans; Abortion, Spontaneous; Misoprostol; Vacuum Curettage; Cost-Effectiveness Analysis; Pregnancy Trimester, First; Ultrasonography, Interventional; Cost-Benefit Analysis
PubMed: 37922290
DOI: 10.1371/journal.pone.0294058 -
Contraception Jan 2022To determine if transdermal scopolamine is associated with decreased postoperative nausea and vomiting and shorter length of stay in the postoperative care unit among...
OBJECTIVE
To determine if transdermal scopolamine is associated with decreased postoperative nausea and vomiting and shorter length of stay in the postoperative care unit among patients undergoing uterine aspiration for abortion or early pregnancy loss.
STUDY DESIGN
We conducted a retrospective cohort study at an integrated medical center that initiated a protocol to prescribe transdermal scopolamine to patients undergoing uterine aspiration under moderate sedation. We compared outcomes among patients who underwent uterine aspiration in 2017, before the institution enacted the protocol, with their counterparts in 2018, immediately after the institution instated the protocol. We reviewed patient charts for data on the postoperative length of stay, use of additional antiemetics, and a standardized clinician designated postoperative nausea and vomiting score. We analyzed outcomes by relevant demographic and clinical characteristics using chi-square or Fisher's exact tests for categorical variables and t tests for continuous variables.
RESULTS
The final sample included 386 patients; 228 who did not receive scopolamine and 158 who did. The cohorts were comparable in terms of demographic and clinical characteristics. The cohort that received transdermal scopolamine had a similar mean postoperative length of stay (75.4 ± 54.1 vs 71.1 ± 50.8 minutes; p = 0.43). There were no differences in the proportions of patients who were provided additional antiemetics (26 ± 11.4 vs 17 ± 10.8; p = 0.84) or had transient vomiting and retching (3 ± 1.9 vs 3 ± 1.3; p = 0.69) between the cohorts.
CONCLUSION
We found no evidence that prophylactic transdermal scopolamine reduces postoperative nausea, vomiting, or length of stay among patients undergoing uterine aspiration.
IMPLICATIONS
Among patients who underwent uterine aspiration under moderate sedation, use of prophylactic transdermal scopolamine was not associated with shorter postoperative length of stay or lesser use of antiemetics. Prophylactic transdermal scopolamine is not likely to be useful for patients undergoing uterine aspiration and could be an unnecessary cost.
Topics: Administration, Cutaneous; Antiemetics; Female; Humans; Length of Stay; Postoperative Nausea and Vomiting; Pregnancy; Retrospective Studies; Scopolamine
PubMed: 34400153
DOI: 10.1016/j.contraception.2021.08.004