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Contraception Jul 2021Evaluate satisfaction and experience with telemedicine consultation and home use of mifepristone and misoprostol for abortion to 10 weeks' gestation.
Client satisfaction and experience of telemedicine and home use of mifepristone and misoprostol for abortion up to 10 weeks' gestation at British Pregnancy Advisory Service: A cross-sectional evaluation.
OBJECTIVE
Evaluate satisfaction and experience with telemedicine consultation and home use of mifepristone and misoprostol for abortion to 10 weeks' gestation.
STUDY DESIGN
Cross-sectional evaluation of British Pregnancy Advisory Service (BPAS) clients who used mifepristone and misoprostol at home from 11 May to 10 July 2020. We sent a text message with a link to a web-survey 2 to 3 weeks postabortion. Questions assessed satisfaction and experiences with a service model including telephone consultation and provision of medicines by mail or collection from the clinic. We used bivariate and multivariate regression to explore associations between client characteristics and outcomes. Our primary outcomes were overall satisfaction (5-point Likert scale) and reported contact with a health care provider.
RESULTS
A total of 1,333 clients participated. Respondents described home use of medications as "straightforward" (75.8%) and most were "very satisfied" (78.3%) or "satisfied" (18.6%) overall. Being "very satisfied" was associated with parity (aOR 1.53, 95% CI 1.09-2.14) and pain control satisfaction (aOR 2.22, 95% CI 1.44-3.44). Health care provider contact was reported by 14.7%; mainly to BPAS' telephone aftercare service (76.8%). Dissatisfaction with pain control (aOR 3.62, 95% CI 1.79-7.29) and waiting >1 week to use mifepristone (aOR3.71, 95% CI 1.48-9.28) were associated with health care provider contact. If needed in the future, most would prefer consultation by phone (74.3%) and home use of mifepristone and misoprostol (77.8%).
CONCLUSIONS
Satisfaction with telemedicine and home use of mifepristone and misoprostol is high. Most clients do not need health care provider support when administering medicines at home or post abortion.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Consultants; Cross-Sectional Studies; Female; Humans; Mifepristone; Misoprostol; Personal Satisfaction; Pregnancy; Referral and Consultation; Telemedicine; Telephone
PubMed: 33974918
DOI: 10.1016/j.contraception.2021.04.027 -
Contraception May 2020To evaluate the characteristics, clinical information, and storage instructions contained in package inserts from medical abortion commodities collected in low- and...
OBJECTIVES
To evaluate the characteristics, clinical information, and storage instructions contained in package inserts from medical abortion commodities collected in low- and middle-income countries.
STUDY DESIGN
From November 2017 to February 2018 mifepristone, misoprostol, and combined mifepristone-misoprostol (combipack) products were collected to populate the Medical Abortion Commodities Database. We extracted stated indications for use, storage instructions, and date of last revision from each package insert obtained. For those inserts listing medical abortion as an indication, we also extracted eligibility criteria, recommended regimens, side effects, and contraindications.
RESULTS
We identified 41 package inserts from 20 countries; 19 (46%) listed medical abortion as an indication including all 7 combipacks, all 7 mifepristone products, and 5/27 (19%) misoprostol products. Date of last insert revision ranged from 1991 to 2016. Gestational age limits for early medical abortion ranged from 49 days to "first trimester." Three (43%) mifepristone products recommended a 600 mg oral dose and two (29%) recommended regimens with gemeprost. Eighteen (67%) misoprostol and one (14%) combipack inserts recommended protection from moisture.
CONCLUSIONS
The characteristics, clinical information, and storage instructions in medical abortion product package inserts from a variety of field settings in low- and middle-income countries included inadequate storage instructions and outdated gestational age limits and regimens.
IMPLICATIONS
There is an urgent need to revisit approved inserts for medical abortion products in low- and middle-income countries to ensure information is accurate and reflects the current evidence base. Simultaneously, providing supplemental instructions targeted at users may fill some gaps. People have a right to accurate information to ensure a safe and effective medical abortion experience.
Topics: Abortifacient Agents; Abortion, Induced; Alprostadil; Cross-Sectional Studies; Developing Countries; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Product Labeling; Treatment Outcome
PubMed: 32032639
DOI: 10.1016/j.contraception.2020.01.011 -
Social Science & Medicine (1982) Jan 2020Misoprostol has during the past few years become an important obstetric drug used for different purposes both within and outside hospitals in Tanzania. In this paper, we...
Misoprostol has during the past few years become an important obstetric drug used for different purposes both within and outside hospitals in Tanzania. In this paper, we analyze how misoprostol is perceived, accessed and used off-label as an abortion drug in the city and region of Dar es Salaam. The study took place in Dar es Salaam's three districts from July to November 2015, and had a qualitative explorative approach. We carried out in-depth interviews (42) with the following main categories of informants: women having undergone medical abortion (15), health care workers with experiences from post abortion care (16) and drug vendors (11). Focus group discussions (10) were carried out with young women. A client simulation study was carried out in 64 drugstores across Dar es Salaam assessing the availability of misoprostol and the advice given concerning its use. In addition, shorter qualitative interviews were carried out with representatives of NGOs and public agencies working with sexual and reproductive health issues (17). Our findings reveal that in Dar es Salaam, misoprostol is well known, available and accessed for abortion purposes through drugstores and health providers. Women tend to prefer misoprostol over other abortion methods since it allows for a private, low-cost, safer and less uncomfortable abortion experience. But, while misoprostol facilitates women's agency in the process of seeking abortion, a series of obstacles shaped by a restrictive abortion law and an unregulated pharmaceutical market hinder its safe use. Central obstacles are profit-seeking providers, suboptimal user instructions and poor provider follow-up. In the discussion of the material we draw upon Van der Geest, Hardon and Whyte's concept of the 'social life of pharmaceuticals' and indicate the ways in which misoprostol acts as an agent of change in the social relations connected to abortion.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Female; Focus Groups; Health Personnel; Humans; Interviews as Topic; Misoprostol; Off-Label Use; Pregnancy; Qualitative Research; Tanzania
PubMed: 31810016
DOI: 10.1016/j.socscimed.2019.112676 -
Biomedicines Feb 2023infection (CDI) is an urgent threat and unmet medical need. The current treatments for CDI are not enough to fight the burden of CDI and recurrent CDI (r-CDI). This... (Review)
Review
infection (CDI) is an urgent threat and unmet medical need. The current treatments for CDI are not enough to fight the burden of CDI and recurrent CDI (r-CDI). This review aims to highlight the future drugs for CDI and their related patented applications. The non-patent literature was collected from PubMed and various authentic websites of pharmaceutical industries. The patent literature was collected from free patent databases. Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons. The patent literature reveals some important inventions for the existing treatments of CDI and supports the possibility of developing more and better CDI-treatment-based inventions, including patient-compliant dosage forms, targeted drug delivery, drug combinations of anti-CDI drugs possessing diverse mechanisms of action, probiotic and enzymatic supplements, and vaccines. The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI.
PubMed: 36830964
DOI: 10.3390/biomedicines11020426 -
Contraception: X 2020Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen. (Review)
Review
BACKGROUND
Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen.
OBJECTIVES
The objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation.
DATA SOURCES
We searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017.
STUDY ELIGIBILITY PARTICIPANTS AND INTERVENTIONS
We included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP).
STUDY APPRAISAL AND SYNTHESIS METHODS
After extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence.
RESULTS
We included 43 of the 1894 references identified. Combination mifepristone-misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04-0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23-7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17-0.88).
LIMITATIONS
Direct comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking.
CONCLUSION
Our analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation.
IMPLICATIONS
Where available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.
PubMed: 32954250
DOI: 10.1016/j.conx.2020.100037 -
International Journal of Molecular... Mar 2022Intestinal mucosal barrier dysfunction caused by disease and/or chemotherapy lacks an effective treatment, which highlights a strong medical need. Our group has...
Intestinal mucosal barrier dysfunction caused by disease and/or chemotherapy lacks an effective treatment, which highlights a strong medical need. Our group has previously demonstrated the potential of melatonin and misoprostol to treat increases in intestinal mucosal permeability induced by 15-min luminal exposure to a surfactant, sodium dodecyl sulfate (SDS). However, it is not known which luminal melatonin and misoprostol concentrations are effective, and whether they are effective for a longer SDS exposure time. The objective of this single-pass intestinal perfusion study in rats was to investigate the concentration-dependent effect of melatonin and misoprostol on an increase in intestinal permeability induced by 60-min luminal SDS exposure. The cytoprotective effect was investigated by evaluating the intestinal clearance of Cr-labeled EDTA in response to luminal SDS as well as a histological evaluation of the exposed tissue. Melatonin at both 10 and 100 µM reduced SDS-induced increase in permeability by 50%. Misoprostol at 1 and 10 µM reduced the permeability by 50 and 75%, respectively. Combination of the two drugs at their respective highest concentrations had no additive protective effect. These in vivo results support further investigations of melatonin and misoprostol for oral treatments of a dysfunctional intestinal barrier.
Topics: Animals; Intestinal Diseases; Intestinal Mucosa; Intestines; Melatonin; Misoprostol; Permeability; Rats
PubMed: 35328333
DOI: 10.3390/ijms23062912 -
Taiwanese Journal of Obstetrics &... Nov 2019Follow-up of the side effects of uterotonics used for postpartum hemorrhage is one of the most important roles of health care providers. In this review, it is aimed to...
Follow-up of the side effects of uterotonics used for postpartum hemorrhage is one of the most important roles of health care providers. In this review, it is aimed to compare the side effects of misoprostol and oxytocin that are used to prevent postpartum hemorrhage. This systematic review was carried out in accordance with the guidelines for the Center for Reviews and Dissemination 2009 (CRD). Articles published in the PubMed, CINAHL, Wiley Interscience, Science Direct and Cochrane databases between 2010 and 2016 were examined. Finally, although 2277 articles were found to be related to misoprostol and oxytocin, only 12 randomized controlled (n = 6290) articles were included in the review. Results: In the misoprostol group, the rate of >500 mL blood loss was lower than that in the oxytocin group (p < 0.05). The groups were similar in terms of ≥500 mL blood loss were similar (p > 0.05). Although misoprostol was more effective than oxytocin in preventing PPH, the side effects of misoprostol were more. The incidence of drug-induced shivering, nausea and increase in body temperature were significantly higher in the misoprostol group than the oxytocin and placebo groups (p < 0.05). Shivering was most frequently seen in the 600 mg of sublingual misoprostol group (56.4%). Severe side effects of uterotonics used to prevent postpartum hemorrhage on maternal health were determined. Nurses and midwives should be aware of the side effects of uterotonic drugs and should develop care guidelines that explain the interventions to be performed in case of side effects.
Topics: Dose-Response Relationship, Drug; Drug Administration Routes; Drug Therapy, Combination; Female; Humans; Maternal Health; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy
PubMed: 31759522
DOI: 10.1016/j.tjog.2019.09.004 -
International Journal of Environmental... Sep 2022Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even...
Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even though misoprostol is a cheaper and safer option, it is rarely used in Malawi. To improve services, an intervention was performed to increase the use of misoprostol in post-abortion care. This study explored healthcare providers' perceptions and experiences with misoprostol in the Malawian setting and their role in achieving effective implementation of the drug. A descriptive phenomenological study was conducted in three hospitals in central Malawi. Focus group discussions were conducted with healthcare workers in centres where the training intervention was offered. Participants were purposefully sampled, and thematic analysis was done. Most of the healthcare workers were positive about the use of misoprostol, knew how to use it and were confident in doing so. The staff preferred misoprostol to surgical treatment because it was perceived safe, effective, easy to use, cost-effective, had few complications, decreased hospital congestion, reduced workload, and saved time. Additionally, misoprostol was administered by nurses/midwives, and not just physicians, thus enhancing task-shifting. The results showed acceptability of misoprostol in post-abortion care among healthcare workers in central Malawi, and further implementation of the drug is recommended.
Topics: Abortion, Incomplete; Abortion, Induced; Female; Health Personnel; Humans; Malawi; Misoprostol; Pregnancy
PubMed: 36231358
DOI: 10.3390/ijerph191912045 -
BMC Pregnancy and Childbirth Jan 2022Rates of maternal mortality and morbidity in Africa remain unacceptably high, as many women deliver at home, without access to skilled birth attendants and life-saving... (Clinical Trial)
Clinical Trial
BACKGROUND
Rates of maternal mortality and morbidity in Africa remain unacceptably high, as many women deliver at home, without access to skilled birth attendants and life-saving medications. In rural Tanzania, women face significant barriers accessing health care facilities for their deliveries.
METHODS
From January 2017 to February 2019 we conducted a multiple baseline (interrupted time series) trial within the four divisions of Rorya District, Tanzania. We collected baseline data, then sequentially introduced a complex intervention in each of the divisions, in randomized order, over 3 month intervals. We allowed for a 6 month transition period to avoid contamination between the pre- and post-intervention periods. The intervention included using community health workers to educate about safe delivery, distribution of birth kits with misoprostol, and a transport subsidy for women living a distance from the health care facility. The primary outcome was the health facility birth rate, while the secondary outcomes were the rates of antenatal and postpartum care and postpartum hemorrhage. Outcomes were analyzed using fixed effects segmented logistic regression, adjusting for age, marital status, education, and parity. Maternal and baby morbidity/mortality were analyzed descriptively.
RESULTS
We analyzed data from 9565 pregnant women (2634 before and 6913 after the intervention was implemented). Facility births increased from 1892 (71.8%) before to 5895 (85.1%) after implementation of the intervention. After accounting for the secular trend, the intervention was associated with an immediate increase in the odds of facility births (OR = 1.51, 95% CI 1.14 to 2.01, p = 0.0045) as well as a small gradual effect (OR = 1.03 per month, 95% CI 1.00 to 1.07, p = 0.0633). For the secondary outcomes, there were no statistically significant immediate changes associated with the intervention. Rates of maternal and baby morbidity/mortality were low and similar between the pre- and post-implementation periods.
CONCLUSIONS
Access to health care facilities can be improved through implementation of education of the population by community health workers about the importance of a health care facility birth, provision of birth kits with misoprostol to women in late pregnancy, and access to a transport subsidy for delivery for women living at a distance from the health facility.
CLINICAL TRIALS REGISTRATION
NCT03024905 19/01/2017.
Topics: Adolescent; Adult; Birth Rate; Child; Community Health Workers; Delivery, Obstetric; Female; Health Education; Health Facilities; Health Services Accessibility; Humans; Infant; Middle Aged; Postnatal Care; Pregnancy; Prenatal Care; Research Design; Rural Population; Social Determinants of Health; Tanzania; Young Adult
PubMed: 35086508
DOI: 10.1186/s12884-022-04408-5