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Obstetrics and Gynecology Aug 2023To evaluate abortion completion after self-managed medication abortion in pregnancies at or beyond 9 weeks of gestation. (Observational Study)
Observational Study
OBJECTIVE
To evaluate abortion completion after self-managed medication abortion in pregnancies at or beyond 9 weeks of gestation.
METHODS
We conducted a prospective observational cohort study in which we recruited callers to three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia who were initiating a self-managed medication abortion. Participants completed a baseline survey over the phone before taking pills and then two follow-up phone surveys 1 and 3 weeks after taking pills. The primary outcome was abortion completion; secondary outcomes included physical experiences and health care seeking and treatment.
RESULTS
Between 2019 and 2020, we enrolled 1,352 participants, 19.5% (264/1,352) of whom self-managed a medication abortion at 9 or more weeks of gestation: 75.0% (198/264) at 9-11 weeks, 19.3% (51/264) at 12-14 weeks, and 5.7% (15/264) at 15-22 weeks. Participants were aged 26 years on average (SD 5.6 years); 56.4% (149/264) used the combined regimen (mifepristone+misoprostol), and 43.6% (115/264) used misoprostol only. At the last follow-up, 89.4% (236/264) had a complete abortion without procedural intervention, 5.3% (14/264) had a complete abortion with manual vacuum aspiration or dilation and curettage procedure, 4.9% (13/264) had an incomplete abortion, and 0.4% (1/264) participants did not report an abortion outcome. Some participants (23.5%, 62/264) sought health care during or after the self-managed medication abortion, most commonly to confirm completion (15.9%, 42/264); 9.1% (24/264) needed further medical intervention (procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or overnight stay in the facility). Those who were 12 or more weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk 1.62, 95% CI 1.3-2.1).
CONCLUSION
People who self-managed an abortion with medication between 9 and 16 weeks of gestation had high levels of abortion completion and accessed health care to confirm completion or to treat potential complications.
CLINICALTRIALREGISTRATION
ISRCTN, ISRCTN95769543.
Topics: Pregnancy; Female; Humans; Misoprostol; Prospective Studies; Self-Management; Abortion, Induced; Mifepristone; Ambulatory Care Facilities
PubMed: 37411022
DOI: 10.1097/AOG.0000000000005266 -
Contraception Oct 2023To measure the prevalence of early pregnancy loss management types among obstetrician-gynecologists in Massachusetts, and delineate barriers, facilitators, demographic...
OBJECTIVES
To measure the prevalence of early pregnancy loss management types among obstetrician-gynecologists in Massachusetts, and delineate barriers, facilitators, demographic and practice-related factors associated with mifepristone use for early pregnancy loss.
STUDY DESIGN
We surveyed a census of obstetrician-gynecologists in Massachusetts. Descriptive statistics measured the prevalence of offering expectant, misoprostol-alone, mifepristone and misoprostol, dilation and curettage in the office and operating room, and multivariate logistic regression analysis evaluated barriers and facilitators to mifepristone use. Data were weighted to account for nonresponders.
RESULTS
198 obstetrician-gynecologists responded to the survey (response rate=29%). Participants most commonly offered expectant management (98%), dilation and curettage in the operating room (94%), and misoprostol-only medication management (80%). Fewer offered mifepristone-misoprostol (51%) or dilation and curettage in an office setting (45%). Those in private practice or other practice types had lower odds of offering mifepristone-misoprostol than those in academic practice (private practice: aOR 0.34, 95% confidence interval [CI] [0.19, 0.61]). Female physicians had higher odds of offering mifepristone-misoprostol (aOR 1.97, 95% CI [1.11, 3.49]). Obstetrician-gynecologists who included medication abortion in their practice had much higher odds of using mifepristone for early pregnancy loss (aOR 25.06, 95% CI [14.52, 43.24]). The Food and Drug Administration Risk and Evaluation Management Strategies Program was a primary barrier among those not using mifepristone (54%).
CONCLUSIONS
Many obstetrician-gynecologists do not offer mifepristone-based regimens for early pregnancy loss, which are more efficacious than misoprostol-only regimens. The Food and Drug Administration Risk Evaluation and Mitigation Strategies Program is a major barrier to mifepristone use.
IMPLICATIONS
Half of obstetrician-gynecologists in Massachusetts do not use mifepristone for early pregnancy loss management. Major barriers include lack of experience with mifepristone and the Food and Drug Administration Risk Evaluation and Mitigation Strategies Program regulations. Removing medically unnecessary regulations and increasing education on mifepristone via access to abortion care experts may increase uptake of this practice.
Topics: Pregnancy; Female; Humans; Mifepristone; Abortion, Spontaneous; Misoprostol; Gynecologists; Obstetricians; Abortion, Induced; Massachusetts
PubMed: 37394110
DOI: 10.1016/j.contraception.2023.110108 -
International Journal of Gynaecology... Nov 2023To determine how many times Ipas manual vacuum aspiration (MVA) instruments are reused, for what reasons, when the instruments are replaced and/or discarded, and what...
OBJECTIVE
To determine how many times Ipas manual vacuum aspiration (MVA) instruments are reused, for what reasons, when the instruments are replaced and/or discarded, and what the barriers are to replacing them.
METHODS
We conducted a mixed-methods cross-sectional study of health care providers who provide MVA services and key stakeholders in the supply chain to understand reuse and replacement of Ipas MVA aspirators and cannulae. Qualitative interviews focused on procurement and replacement of Ipas MVA instruments.
RESULTS
The authors interviewed 352 health care providers from nine countries from 2019 to 2021. Providers reported reusing MVA instruments an average of 34.4 times (standard deviation, 45). The reuse averages ranged from one time (Democratic Republic of the Congo) to 500 times (India), with figures varying between providers within the same country. Instrument malfunctioning rather than a specific number of uses drove reuse and subsequent replacement. The decision to replace was most commonly made by the provider during use. Half of the providers said that they knew of no issues with the supply chain, and 85% said they were always able to replace Ipas MVA instruments when needed.
CONCLUSION
Tracking reuse of MVA instruments was uncommon at participating providers' health facilities. Providers' estimates revealed great variability in reuse frequency and tracking procedures.
Topics: Female; Humans; Pregnancy; Abortion, Induced; Cannula; Cross-Sectional Studies; Health Personnel; Vacuum Curettage; Equipment Reuse
PubMed: 37341207
DOI: 10.1002/ijgo.14905 -
Cardiovascular Revascularization... Dec 2023Transcatheter aspiration is utilized for removal of thrombi and vegetations in inoperable patients and high-risk surgical candidates where medical therapy alone is...
BACKGROUND
Transcatheter aspiration is utilized for removal of thrombi and vegetations in inoperable patients and high-risk surgical candidates where medical therapy alone is unlikely to achieve desired outcome. A number of case reports and series have been published since the introduction of AngioVac system (AngioDynamics Inc., Latham, NY) in 2012 where this technology was used in the treatment of endocarditis. However, there is a lack of consolidated data reporting on patient selection, safety and outcomes.
METHODS
PubMed and Google Scholar databases were queried for publications reporting cases where transcatheter aspiration was used for endocarditis vegetation debulking or removal. Data on patient characteristics, outcomes and complications from select reports were extracted and systematically reviewed.
RESULTS
Data from 11 publications with 232 patients were included in the final analyses. Of these, 124 had lead vegetation aspiration, 105 had valvular vegetation aspiration, and 3 had both lead as well as valvular vegetation aspiration. Among the 105 valvular endocarditis cases, 102 (97 %) patients had right sided vegetation removal. Patients with valvular endocarditis were younger (mean age 35 years) vs. patients with lead vegetations (mean age 66 years). Among the valvular endocarditis cases, there was a 50-85 % reduction in vegetation size, 14 % had worsening valvular regurgitation, 8 % had persistent bacteremia and 37 % required blood transfusion. Surgical valve repair or replacement was subsequently performed in 3 % and in-hospital mortality was 11 %. Among patients with lead infection, procedural success rate was reported at 86 %, 2 % had vascular complications and in-hospital mortality was 6 %. Persistent bacteremia, renal failure requiring hemodialysis, and clinically significant pulmonary embolism occurred in about 1 % each.
CONCLUSIONS
Transcatheter aspiration of vegetations in infective endocarditis has acceptable success rates in vegetation debulking as well as rates of morbidity or mortality. Large prospective multi-center studies are warranted to determine predictors of complications, thus helping identify suitable patients.
Topics: Female; Humans; Adult; Aged; Prospective Studies; Vacuum Curettage; Endocarditis, Bacterial; Endocarditis; Bacteremia
PubMed: 37331887
DOI: 10.1016/j.carrev.2023.06.006 -
International Journal of Gynaecology... Oct 2023Manual vacuum aspiration (MVA) is a safe and effective alternative option for the management of first-trimester miscarriage, termination of pregnancy, or retained...
INTRODUCTION
Manual vacuum aspiration (MVA) is a safe and effective alternative option for the management of first-trimester miscarriage, termination of pregnancy, or retained pregnancy tissue. Ireland's first MVA clinic was set up in the Rotunda Hospital in April 2020.
OBJECTIVE
To identify the number of women who have undergone MVA since establishing our service, to assess the efficacy and safety of MVA in that service, and to develop local Irish studies that further support the safety of MVA, adding to the international body of evidence.
METHODS
With the approval and assistance of the Clinical Audit Committee, we obtained a log of all patients who underwent MVA in the first 18 months of the service. We performed a retrospective electronic chart review using Maternal and Newborn Clinical Management System. We collected the data and preformed a descriptive analysis.
RESULTS
In total, 86 women underwent MVA, 85 (98.8%) of which were successfully completed. There were no immediate procedural complications, inter-hospital transfers, or emergency electric vacuum aspiration (EVA) required. We obtained an incomplete evacuation rate of 4.7% (n = 4).
CONCLUSION
We have demonstrated that the MVA service in the Rotunda Hospital is a safe, effective management option with advantages for both the patient and the healthcare system. We recommend consideration for provision of funding and resources to enable expansion of this service nationally in order to give women greater autonomy of choice in the management of early pregnancy complications and termination of pregnancy.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Vacuum Curettage; Retrospective Studies; Ireland; Pregnancy Trimester, First; Abortion, Spontaneous; Abortion, Induced
PubMed: 37198749
DOI: 10.1002/ijgo.14836 -
American Journal of Obstetrics and... Oct 2023Cesarean scar ectopic pregnancy is a type of ectopic pregnancy in which the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Cesarean scar ectopic pregnancy is a type of ectopic pregnancy in which the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean delivery. The condition can be catastrophic if not managed on time and can lead to significant morbidity and mortality. Several approaches have been studied for the management of cesarean scar ectopic pregnancy in women who opted for termination of pregnancy with no consensus on the best treatment modality reached so far.
OBJECTIVE
This study aimed to compare the success rate of hysteroscopic resection vs ultrasound-guided dilation and evacuation for the treatment of cesarean scar ectopic pregnancy.
STUDY DESIGN
This was a parallel group, nonblinded, randomized clinical trial conducted at a single center in Italy. Women with singleton gestations at <8 weeks and 6 days of gestation were included in the study. Inclusion criteria were women with a cesarean scar ectopic pregnancy with positive embryonic heart activity who opted for termination of pregnancy. Patients were randomized 1:1 to receive either hysteroscopic resection (ie, intervention group) or ultrasound-guided dilation and evacuation (ie, control group). Both groups received 50 mg/m of methotrexate intramuscularly at the time of randomization (day 1) and another dose at day 3. A third dose of methotrexate was planned in case of persistence of positive fetal heart activity at day 5. Participants received either ultrasound-guided dilation and evacuation or hysteroscopic resection from 1 to 5 days after the last dose of methotrexate. Hysteroscopic resection was performed under spinal anesthesia using a 15 Fr bipolar mini-resectoscope. Dilation and evacuation were performed by vacuum aspiration with a Karman cannula, followed by sharp curettage, if necessary, under ultrasound guidance. The primary outcome was the success rate of the treatment protocol, defined as no further treatment required until the complete resolution of the cesarean scar ectopic pregnancy. Resolution of the cesarean scar ectopic pregnancy was evaluated based on decline of beta-hCG and the absence of residual gestational material in the endometrial cavity. Treatment failure was defined as the necessity for further treatment required until the complete resolution of the cesarean scar ectopic pregnancy. A sample size calculation indicated that 54 participants were required to test the hypothesis RESULTS: A total of 54 women were enrolled and randomized. Number of previous cesarean deliveries ranged from 1 to 3. Overall, 10 women received a third dose of methotrexate with 7 of 27 (25.9%) participants in the hysteroscopic resection group and 3 of 27 (11.1%) in the dilation and evacuation group. The success rate was 100% (27/27) in the hysteroscopic resection group and 81.5% (22/27) in the dilation and evacuation group (relative risk, 1.22; 95% confidence interval, 1.01-1.48). Additional procedures were required in 5 cases of the control group, namely 3 hysterectomies, 1 laparotomic uterine segmental resection, and 1 hysteroscopic resection. The length of stay in the hospital was 9.0±2.9 days in the intervention group and 10.0±3.5 days in the control group (mean difference, -1.00 days; 95% confidence interval, -2.71 to 0.71). No cases of admission to intensive care unit or maternal death were reported.
CONCLUSION
Hysteroscopic resection was associated with an increased success rate in the treatment of cesarean scar ectopic pregnancy when compared with ultrasound-guided dilation and evacuation.
Topics: Pregnancy; Female; Humans; Male; Methotrexate; Dilatation; Cicatrix; Abortifacient Agents, Nonsteroidal; Cesarean Section; Pregnancy, Ectopic; Ultrasonography, Interventional; Retrospective Studies
PubMed: 37142075
DOI: 10.1016/j.ajog.2023.04.038 -
Archives of Gynecology and Obstetrics Sep 2023To analyze the predictive value of clinical and ultrasound parameters for treatment failure after administration of methotrexate (MTX) in combination with suction...
PURPOSE
To analyze the predictive value of clinical and ultrasound parameters for treatment failure after administration of methotrexate (MTX) in combination with suction curettage (SC) in treatment of cesarean scar pregnancy (CSP) in the early first trimester.
METHODS
In this retrospective cohort study, electronic medical records of patients diagnosed with CSP and initially treated between 2015 and 2022 with MTX combined with SC were reviewed and outcome data were collected.
RESULTS
127 patients met inclusion criteria. 25 (19.69%) required additional treatment. Logistic regression analysis indicated that factors independently associated with the need for additional treatment included progesterone level > 25 mIU/mL (OR: 1.97; 95% CI: 0.98-2.87, P = 0.039), abundant blood flow (OR: 5.19; 95% CI: 2.44-16.31, P = 0.011), gestational sac size > 3 cm (OR: 2.54; 95% CI: 1.12-6.87, P = 0.029), and the myometrial thickness between the bladder and gestational sac < 2.5 mm (OR: 3.48; 95% CI: 1.91-6.98, P = 0.015).
CONCLUSIONS
Our study identified several factors which increase the need for additional treatment following the initial treatment of CSP with MTX and SC. Alternative therapy should be considered if these factors are present.
Topics: Pregnancy; Female; Humans; Methotrexate; Vacuum Curettage; Cicatrix; Retrospective Studies; Cesarean Section; Pregnancy, Ectopic; Curettage; Risk Factors; Treatment Outcome
PubMed: 37131042
DOI: 10.1007/s00404-023-07049-x -
Sexual and Reproductive Health Matters Dec 2023Although Pakistan's Essential Package of Health Services was recently updated to include therapeutic and post-abortion care, little is known about current health...
Although Pakistan's Essential Package of Health Services was recently updated to include therapeutic and post-abortion care, little is known about current health facility readiness for these services. This study assessed the availability of comprehensive abortion care, and readiness of health facilities to deliver these services, within the public sector in 12 districts of Pakistan. A facility inventory was completed in 2020-2021 using the WHO Service Availability and Readiness Assessment, with a newly developed abortion module. A composite readiness indicator was developed based on national clinical guidelines and previous studies. Just 8.4% of facilities reported offering therapeutic abortion, while 14.3% offered post-abortion care. Misoprostol (75.2%) was the most common method provided by facilities that offer therapeutic abortion, followed by vacuum aspiration (60.7%) and dilatation and curettage (D&C) (59%). Few facilities had all the readiness components required to deliver pharmacological or surgical therapeutic abortion, or post-abortion care (<1%), but readiness was higher in tertiary (22.2%) facilities. Readiness scores were lowest for "guidelines and personnel" (4.1%), and slightly higher for medicines and products (14.3-17.1%), equipment (16.3%) and laboratory services (7.4%). This assessment highlights the potential to increase the availability of comprehensive abortion care in Pakistan, particularly in primary care and in rural areas, to improve the readiness of health facilities to deliver these services, and to phase out non-recommended methods of abortion (D&C). The study also demonstrates the feasibility and utility of adding an abortion module to routine health facility assessments, which can inform efforts to strengthen sexual and reproductive health and rights.
Topics: Pregnancy; Female; Humans; Health Services Accessibility; Pakistan; Abortion, Induced; Health Facilities; World Health Organization
PubMed: 36897212
DOI: 10.1080/26410397.2023.2178265