-
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from a variety of field settings in low- and middle-income countries included inadequate storage instructions and outdated gestational age limits and regimens.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 -
Contraception Apr 2016First-trimester surgical abortion is a common, safe procedure with a major complication rate of less than 1%. Cervical dilation before suction abortion is usually... (Review)
Review
First-trimester surgical abortion is a common, safe procedure with a major complication rate of less than 1%. Cervical dilation before suction abortion is usually accomplished using tapered mechanical dilators. Risk factors for major complications in the first trimester include increasing gestational age and provider inexperience. Cervical priming before first-trimester surgical abortion has been studied using osmotic dilators and pharmacologic agents, most commonly misoprostol. Extensive data demonstrate that a variety of agents are safe and effective at causing preoperative cervical softening and dilation; however, given the small absolute risk of complications, the benefit of routine use of misoprostol or osmotic dilators in first-trimester surgical abortion is unclear. Although cervical priming results in reduced abortion time and improved provider ease, it requires a delay of at least 1 to 3 h and may confer side effects. The Society of Family Planning does not recommend routine cervical priming for first-trimester suction abortion but recommends limiting consideration of cervical priming for women at increased risk of complications from cervical dilation, including those late in the first trimester, adolescents and women in whom cervical dilation is expected to be challenging.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adolescent; Dilatation; Female; Gestational Age; Humans; Laminaria; Misoprostol; Pregnancy; Pregnancy Trimester, First; Professional Practice Location
PubMed: 26683499
DOI: 10.1016/j.contraception.2015.12.001 -
Journal of Obstetrics and Gynaecology... Dec 2020To assess the efficacy of oral misoprostol for induction of labour (IOL) in the context of term pre-labour rupture of membranes (TPROM), and to assess pregnancy outcomes... (Review)
Review
OBJECTIVE
To assess the efficacy of oral misoprostol for induction of labour (IOL) in the context of term pre-labour rupture of membranes (TPROM), and to assess pregnancy outcomes following the administration of oral misoprostol.
DATA SOURCES
A systematic literature search was performed using Ovid Medline, Embase, PubMed, and the Cochrane Database of Systematic Reviews.
STUDY SELECTION
Eligible studies were quasi-experimental trials or randomized controlled trials involving the use of oral misoprostol in singleton cephalic term pregnancies with confirmed rupture of membranes and no spontaneous labour at the time of membranes rupture, in mothers with no contraindications to vaginal delivery. Studies were excluded if they utilized vaginal misoprostol, excluded primigravid participants, or if the full text of the article was not accessible in English.
DATA EXTRACTION
Data were extracted by two reviewers using a standardized data extraction form. Study quality was assessed using the modified Jadad score.
DATA SYNTHESIS
Twelve randomized controlled trials that included 1489 singleton pregnancies were included. Doses of oral misoprostol ranged from 20 to 200 μg. The incidence of vaginal birth ranged from 73.0%-95.0% in the oral misoprostol group compared with 52.4%-94% in the control group. Hyperstimulation was infrequent, ranging from 0% to 13.8% in the oral misoprostol group compared with 0%-24% in the control group. Two trials, involving a total of 144 women that compared 50 μg of oral misoprostol every 4 hours versus expectant management followed by PGE gel showed a higher incidence of vaginal birth with misoprostol (pooled risk ratio 1.33, 95% confidence interval 1.10-1.61).
CONCLUSION
Oral misoprostol appears to be a safe and effective for IOL in TPROM. However, the varying administration, dose, and frequency reported in the literature highlights the need to develop a standardized protocol for use in Canadian obstetrical practice.
Topics: Administration, Intravaginal; Administration, Oral; Canada; Cervical Ripening; Female; Fetal Membranes, Premature Rupture; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, Third
PubMed: 32362580
DOI: 10.1016/j.jogc.2020.02.111 -
Contraception Apr 2018We aimed to document the experience of buying abortion pills from online vendors that do not require a prescription and to evaluate the active ingredient content of the...
OBJECTIVES
We aimed to document the experience of buying abortion pills from online vendors that do not require a prescription and to evaluate the active ingredient content of the pills received.
STUDY DESIGN
We searched the internet to identify a convenience sample of websites that sold mifepristone and misoprostol to purchasers in the United States and attempted to order these products. We documented price, shipping time and other aspects of ordering. We sent the samples received to a testing laboratory that measured the amount of active ingredient in individual tablets.
RESULTS
We identified 18 websites and ordered 22 products: 20 mifepristone-misoprostol combination products and 2 that contained only misoprostol. We received 18 combination products and the 2 misoprostol products from 16 different sites. No site required a prescription or any relevant medical information. The time between order and receipt of the 20 products ranged from 3 to 21 business days (median 9.5 days). The price for the 18 combination products ranged from $110 to $360, including shipping and fees; the products without mifepristone cost less. Chemical assays found that the 18 tablets labeled 200 mg mifepristone contained between 184.3 mg and 204.1 mg mifepristone, while the 20 tablets labeled 200 mcg misoprostol contained between 34.1 mcg and 201.4 mcg of the active ingredient.
CONCLUSIONS
Obtaining abortion medications from online pharmaceutical websites is feasible in the United States. The mifepristone tablets received contained within 8% of the labeled amount of active agent. The misoprostol tablets all contained that compound but usually less than labeled.
IMPLICATIONS STATEMENT
Given our findings, we expect that some people for whom clinic-based abortion is not easily available or acceptable may consider self-sourcing pills from the internet to be a rational option.
Topics: Abortion, Induced; Counterfeit Drugs; Drug Costs; Drug Therapy, Combination; Female; Health Services Accessibility; Humans; Internet; Mifepristone; Misoprostol; Pregnancy; United States
PubMed: 29030227
DOI: 10.1016/j.contraception.2017.09.016 -
International Journal of Gynaecology... Nov 2020To determine whether addition of letrozole to a misoprostol-based abortion regimen can increase the rate of complete abortion. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To determine whether addition of letrozole to a misoprostol-based abortion regimen can increase the rate of complete abortion.
METHODS
The randomized, placebo-controlled, double-blind trial enrolled women with missed abortion in the first trimester of pregnancy attending Sadooghi Hospital, Isfahan, Iran, from 2016 to 2018. The women were randomly assigned to the study group, which received 10 mg of letrozole daily for 3 days, followed by two doses of 800 μg of vaginal misoprostol at a 4-hour interval, or the control group, which received a placebo, followed by the same dose of misoprostol. Sonography was performed to check the abortion status.
RESULTS
In total, 120 women completed the study: 60 in the misoprostol plus letrozole group, and 60 in the misoprostol only group. Complete abortion was documented for 93 (77.5%) women: 48 (80.0%) in the misoprostol plus letrozole group and 45 (75.0%) in the misoprostol only group (P=0.80). The mean duration of induction in the misoprostol plus letrozole and misoprostol only groups was 7.35 ± 3.54 hours and 8.2 ± 3.8 4hours, respectively (P=0.21).
CONCLUSION
Administration of misoprostol alone was found to be as effective as the administration of misoprostol plus letrozole for first-trimester missed abortion.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Missed; Administration, Intravaginal; Adult; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Iran; Letrozole; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prenatal Care; Treatment Outcome; Young Adult
PubMed: 32700359
DOI: 10.1002/ijgo.13326 -
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 -
International Perspectives on Sexual... Oct 2019In Bangladesh, prior to the availability of the approved combination regimen of mifepristone and misoprostol for menstrual regulation (MR), drug seller provision of...
CONTEXT
In Bangladesh, prior to the availability of the approved combination regimen of mifepristone and misoprostol for menstrual regulation (MR), drug seller provision of misoprostol-only regimens for MR without a prescription was widespread but service quality was poor. Examining provider practices relating to misoprostol-only provision in Bangladesh may increase understanding of misoprostol use and provision in other low-resource, legally restrictive settings.
METHODS
In 2013-2014, a countrywide cross-sectional knowledge, attitudes and practice survey was conducted among 777 randomly selected drug sellers; data were analyzed descriptively. Logistic regression was used to test the associations between exposure to three interventions designed to improve drug seller practice (nongovernmental organization [NGO]-led training, a call center and in-shop training from pharmaceutical company representatives) and correct knowledge of the misoprostol-only MR regimen.
RESULTS
Almost all (97%) of the drug sellers reported providing medications intended for MR; misoprostol-only was more commonly sold than the combination regimen (96% vs. 26%). Nine percent had received NGO-led training, 62% had received in-shop training from a pharmaceutical company representative and 27% had used the call center. Overall, 19% of drug sellers knew the correct misoprostol-only MR regimen, and 74% wanted more information about this regimen. Correct regimen knowledge was positively associated with receipt of NGO training and call center utilization (odds ratios, 2.0 and 1.9, respectively).
CONCLUSIONS
NGO-led training and call centers should be considered in other settings in which misoprostol alone is provided off-label for pregnancy termination.
Topics: Abortifacient Agents, Nonsteroidal; Adult; Attitude of Health Personnel; Bangladesh; Cross-Sectional Studies; Female; Humans; Menstruation-Inducing Agents; Mifepristone; Misoprostol; Outcome Assessment, Health Care; Pharmaceutical Services; Pharmacies
PubMed: 31639080
DOI: 10.1363/45e7819 -
BJOG : An International Journal of... Feb 2016Various methods are used for cervical ripening during the induction of labour. It is still debatable which of these methods of treatment is optimal. (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Various methods are used for cervical ripening during the induction of labour. It is still debatable which of these methods of treatment is optimal.
OBJECTIVE
To compare treatment techniques for cervical ripening in the induction of labour.
SEARCH STRATEGY
Medline, Embase, and the Cochrane Collaboration databases were searched using the keywords 'cervical ripening', 'labour induced', 'misoprostol', 'dinoprostone', and 'Foley catheter'.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of cervical ripening during the induction of labour, evaluating rates of failure to achieve vaginal delivery within 24 hours, incidence of uterine hyperstimulation with fetal heart rate (FHR) changes, and rates of caesarean section. Studies including women with prelabour rupture of membranes were excluded.
DATA COLLECTION AND ANALYSIS
Outcome data were collected and analysed through pairwise meta-analysis and network meta-analysis within a Bayesian framework.
MAIN RESULTS
A total of 96 RCTs (17,387 women) were included in the meta-analysis. Vaginal misoprostol was the most effective cervical ripening method to achieve vaginal delivery within 24 hours, but had the highest incidence of uterine hyperstimulation with FHR changes. The use of a Foley catheter to induce labour was associated with the lowest rate of uterine hyperstimulation accompanied by FHR changes. The caesarean section rate was lowest using oral misoprostol for the induction of labour.
AUTHOR'S CONCLUSIONS
No method of labour induction demonstrated overall superiority when considering all three clinical outcomes. Decisions regarding the choice of induction method will depend upon the relative preference for effecting vaginal delivery within 24 hours, minimising the incidence of uterine hyperstimulation with adverse FHR changes and avoiding caesarean section.
TWEETABLE ABSTRACT
Oral misoprostol for the induction of labour is safer than vaginal misoprostol and has the lowest rate of caesarean section.
Topics: Cervical Ripening; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Urinary Catheterization; Urinary Catheters
PubMed: 26538408
DOI: 10.1111/1471-0528.13456 -
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 Jun 2017In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance...
BACKGROUND
In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance distribution of misoprostol to pregnant women. In the years since, the government has scaled-up the program throughout much of the country. This paper presents findings from the first large-scale assessment of the effectiveness of the advance distribution program.
METHODS
Data collection was carried out in nine districts and all three ecological zones. To assess knowledge, receipt and use of misoprostol, household interviews were conducted with 2070 women who had given birth within the past 12 months. To assess supply and provision of misoprostol, interviews were conducted with 270 Female Community Health Volunteers (FCHVs) and staff at 99 health facilities.
RESULTS
Among recently delivered women, only 15% received information about misoprostol and 13% received misoprostol tablets in advance of delivery. Yet 87% who received advance misoprostol and delivered at home used it for PPH prevention. Among FCHVs, 96% were providing advance misoprostol for PPH prevention; however 81% had experienced at least one misoprostol stock out within the past year. About one-half of FCHVs were providing incomplete information about the use of misoprostol; in addition, many did not discuss side effects, how to recognize PPH or where to go if PPH occurs. Among health facilities, just one-half had sufficient misoprostol stock, while 95% had sufficient oxytocin stock, at the time of this assessment.
CONCLUSIONS
In Nepal, women who receive advance misoprostol are both willing and able to use the medication for PPH prevention during home births. However the supply and personnel challenges identified raise questions about scalability and impact of the program over the long-term. Further assessment is needed.
Topics: Adolescent; Adult; Community Health Workers; Female; Health Facilities; Health Knowledge, Attitudes, Practice; Humans; Interviews as Topic; Misoprostol; Nepal; Oxytocics; Oxytocin; Patient Education as Topic; Postpartum Hemorrhage; Pregnancy; Program Evaluation; Volunteers; Young Adult
PubMed: 28583092
DOI: 10.1186/s12884-017-1347-z