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Obstetrics and Gynecology May 2024To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion.
OBJECTIVE
To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion.
METHODS
We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens.
RESULTS
Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively (P=.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively (P<.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion (P=.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion (P=.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups.
CONCLUSION
A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT04160221.
PubMed: 38781593
DOI: 10.1097/AOG.0000000000005535 -
Issues in Law & Medicine 2024The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing...
The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.
Topics: United States; United States Food and Drug Administration; Humans; Pregnancy; Abortion, Induced; Female; Misoprostol; Mifepristone
PubMed: 38771713
DOI: No ID Found -
PloS One 2024[This corrects the article DOI: 10.1371/journal.pone.0227245.].
[This corrects the article DOI: 10.1371/journal.pone.0227245.].
PubMed: 38768081
DOI: 10.1371/journal.pone.0304233 -
Contraception May 2024To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality.
OBJECTIVES
To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality.
STUDY DESIGN
Using a secret shopper survey, researchers attempted to contact all community pharmacies in Oregon and evaluate their mifepristone and misoprostol provisions.
RESULTS
Among the 444 pharmacies surveyed, mifepristone was planned at 19.2%. Misoprostol was available at 77.5%, but stocking issues and medication ordering impact access, without significant differences by rurality.
CONCLUSIONS
Pharmacy engagement and support are key to increasing access to these essential medicines, which may be improved through education and referral programs.
PubMed: 38763275
DOI: 10.1016/j.contraception.2024.110491 -
Reproductive Health May 2024In 2019, the World Health Organization identified improving access to safe abortion as an important priority toward improving sexual and reproductive health and rights...
BACKGROUND
In 2019, the World Health Organization identified improving access to safe abortion as an important priority toward improving sexual and reproductive health and rights and achieving Sustainable Development Goals. One strategy for addressing this priority is strengthening access to medicines for medical abortion. All 11 countries in the South-East Asia Region have some indications for legal abortion and permit post-abortion care. Therefore, strengthening access to medical abortion medicines is a reasonable strategy for improving access to safe abortion for the Region.
METHODOLOGY
We applied an adapted version of an existing World Health Organization landscape assessment protocol for the availability of medical abortion medicines at the country-level in the South-East Asia Region. We collected publicly available data on the existence of national health laws, policies, and standard treatment guidelines; inclusion of medical abortion medicines in the national essential medicines list; and marketing authorization status for medical abortion medicines for each country and verified by Ministries of health. The findings were once more presented, discussed and recommendations were formulated during regional technical consultation workshop. Each country teams participated in the process, and subsequently, the suggestions were validated by representatives from Ministries of Health..
RESULTS
Few countries in the Region currently have national policies and guidelines for comprehensive safe abortion. However, either mifepristone-misoprostol in combination or misoprostol alone (for other indications) is included in national essential medicines lists in all countries except Indonesia and Sri Lanka. Few countries earmark specific public funds for procuring and distributing medical abortion commodities. In countries where abortion is legal, the private sector and NGOs support access to medical abortion information and medicines. Several countries only allow registered medical practitioners or specialists to administer medical abortion.
CONCLUSION
Following this rapid participatory assessment and technical consultation workshop, the World Health Organization South-East Asia Regional Technical Advisory and Sexual and Reproductive Health and Rights technical committee recommended priority actions for policy and advocacy, service delivery, and monitoring and evaluation, and indicated areas for support.
Topics: Humans; Asia, Southeastern; World Health Organization; Health Services Accessibility; Female; Pregnancy; Abortion, Induced; Abortifacient Agents; Drugs, Essential
PubMed: 38760864
DOI: 10.1186/s12978-024-01791-4 -
Journal of Minimally Invasive Gynecology May 2024To investigate the feasibility of operative hysteroscopy by a hysteroscopic tissue removal system (HTRS) without anesthesia in women with endometrial polyps (EP) or...
STUDY OBJECTIVE
To investigate the feasibility of operative hysteroscopy by a hysteroscopic tissue removal system (HTRS) without anesthesia in women with endometrial polyps (EP) or retained products of conception (RPOC).
DESIGN
Prospective observational cohort study.
SETTING
University-affiliated Department of Obstetrics and Gynecology.
PATIENTS
Consenting women aged >18 years diagnosed with EP or RPOC from 9/2022 to 8/2023 confirmed by a prior office hysteroscopy.
INTERVENTIONS
Office-based vaginoscopic operative hysteroscopy without anesthesia using the Mini-Elite Truclear HTRS. Oral misoprostol was prescribed for cervical ripening. The patients rated intraoperative and 5-minute postoperative pain levels on a visual analog scale, with mild pain defined as a score of 0 to 4, moderate as 5 to 7, and severe as 8 to 10. A successful procedure was defined as complete removal of the pathology.
MEASUREMENTS AND MAIN RESULTS
Fifty patients were included in this pilot study, and 47 (94.0%) procedures were completed successfully, including 21/24 (87.5%) cases of EP and all cases of RPOC (26/26, p = .06). No intra- or postoperative complications occurred. The intraoperative pain levels were rated as mild, moderate, and severe by 26 (52.0%), 16 (32.0%) and 8 (16.0%) patients, respectively. Severe intraoperative pain was more common in nulliparous women and those >10 years from their last vaginal delivery and was not associated with patient age, menopausal status, presence of abnormal uterine bleeding, or pathology size. Severe postoperative pain, reported by 5 (10.0%) patients, was significantly associated with removal of EP compared with RPOC, longer operative time, and nulliparity or >10 years from the last vaginal delivery. The procedure was considered acceptable by 46 (92.0%) patients, and 45 (90.0%) would recommend it to a friend/relative.
CONCLUSIONS
Office-based operative hysteroscopy by the HTRS is successful and well tolerated by most women, especially for RPOC removal.
PubMed: 38740128
DOI: 10.1016/j.jmig.2024.05.005 -
JAMA Internal Medicine May 2024Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.
IMPORTANCE
Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.
OBJECTIVE
To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.
DESIGN, SETTING, AND PARTICIPANTS
This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023.
INTERVENTION
Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person.
MAIN OUTCOMES AND MEASURES
Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications.
RESULTS
Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing.
CONCLUSIONS AND RELEVANCE
The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.
PubMed: 38739404
DOI: 10.1001/jamainternmed.2024.1476 -
Frontiers in Medicine 2024Mifepristone-misoprostol treatment for medical abortion and miscarriage are safe and effective. This study aimed to assess clinical factors associated with subsequent...
INTRODUCTION
Mifepristone-misoprostol treatment for medical abortion and miscarriage are safe and effective. This study aimed to assess clinical factors associated with subsequent surgical intervention after medical termination of early viable or non-viable pregnancy.
METHODS
This retrospective, single-center study included women who underwent medical abortion at Taipei Medical University between January 2010 and December 2019. A total of 1,561 subjects, with 1,080 viable and 481 non-viable pregnancies, who were treated with oral mifepristone 600 mg followed by misoprostol 600 mg 48 h later were included. Data of all pregnancies and medical termination of pregnancy were evaluated using regression analysis. The main outcome was successful termination of pregnancy.
RESULTS
The success rate of medical abortion was comparable in women with viable and non-viable (92.13% vs. 92.93%) pregnancies. Besides retained tissue, more existing pregnancies with ultrasonographic findings were found in the non-viable pregnancy group than in the viable pregnancy group (29.4% vs. 14.1%, = 0.011). Multivariate analysis showed that previous delivery was an independent risk factor for failed medical abortion among all included cases. In women with viable pregnancy, longer gestational age [adjusted odds ratio (aOR): 1.483, 95% confidence interval (CI): 1.224-1.797, < 0.001] and previous Cesarean delivery (aOR: 2.177, 95% CI: 1.167-40.62, = 0.014) were independent risk factors for failed medical abortion. Number of Cesarean deliveries (aOR: 1.448, 95% CI: 1.029-2.039, = 0.034) was an independent risk factor for failed medication abortion in women with non-viable pregnancies.
CONCLUSION
This is the first cohort study to identify risk factors for subsequent surgical intervention in women with viable or non-viable pregnancies who had undergone early medically induced abortions. The success rate of medical abortion is comparable in women with viable and non-viable pregnancies. Previous delivery is an independent risk factor for failed medical abortion. Clinical follow-up may be necessary for women who are at risk of subsequent surgical intervention.
PubMed: 38737765
DOI: 10.3389/fmed.2024.1188629 -
BJOG : An International Journal of... May 2024To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low-dose oral...
OBJECTIVE
To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low-dose oral misoprostol is superior to intravenous oxytocin.
DESIGN
Open-label, superiority randomised trial.
SETTING
Government hospitals in India.
POPULATION
Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture.
METHODS
Participants received misoprostol (25 micrograms, orally, 2-hourly) or titrated oxytocin through an infusion pump. All women had one-to-one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring.
MAIN OUTCOME MEASURES
Caesarean birth.
RESULTS
A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81-1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207-244 min, vs 194 min, 179-210 min; aOR 1.137; 95% CI 1.023-1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203-1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups.
CONCLUSIONS
Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial.
PubMed: 38726770
DOI: 10.1111/1471-0528.17839 -
Heliyon May 2024To investigate the protective effects against abnormal uterine bleeding (AUB) and possible mechanisms of Xue Ping tablets (XPT) using a rat model.
OBJECTIVE
To investigate the protective effects against abnormal uterine bleeding (AUB) and possible mechanisms of Xue Ping tablets (XPT) using a rat model.
METHODS
A total of 58 unmated female and 25 male SPF SD rats aged 8-9 weeks were selected. Eight unmated female rats were selected as the blank control group according to the complete random method. The other 50 rats were mated in a female/male ratio of 2:1. In the morning after mating, vaginal smears were collected. Presence of vaginal plug or sperm was regarded as the first day of pregnancy. All pregnant rats were given 8.3 mg/kg of mifepristone by gavage at 8:00 a.m. and 100 μg/kg misoprostol by gavage at 6:00 p.m. on the seventh day of pregnancy to induce incomplete abortion, thereby establishing a rat model of AUB. Forty rats were randomly divided into model, low- (220 mg/kg), medium- (441 mg/kg), high-dose (882 mg/kg) XPT, and positive control groups. The positive group was given 130 mg/kg Gong Xue Ning (GXN). The model group and the blank group were given an equal amount of distilled water.
RESULTS
Compared with the model group, the volume of bleeding in the positive and middle- and high-dose XPT groups decreased ( < 0.05). Moreover, compared with the model group, the progesterone levels in the positive and XPT groups were significantly increased. Immunohistochemistry showed that XPT significantly decreased the expression levels of VEGF, -ERK, NF-κB, SAA, MMP-2, MMP-9, TIMP-1, TIMP-2 and TIMP-3. WB results showed that XPT significantly decreased the expression levels of -ERK, MMP-9, NF-κB, MMP-2 and VEGF. QRT-PCR results showed that XPT significantly decreased the expression levels of VEGF, NF-κB, SAA, MMP-2, TIMP-1, TIMP-2 and TIMP-3 ( < 0.05).
CONCLUSIONS
XPT could reduce AUB by inhibiting the inflammatory factors involved in the VEGF-ERK1/2 pathway.
PubMed: 38694046
DOI: 10.1016/j.heliyon.2024.e30079