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BMC Women's Health Oct 2023To date, the association between retained placenta and treatment success rate of misoprostol for early pregnancy failure has yet to be evaluated. The aim of this study...
BACKGROUND
To date, the association between retained placenta and treatment success rate of misoprostol for early pregnancy failure has yet to be evaluated. The aim of this study was to evaluate this association and further investigated the connection between medical, clinical and sonographic parameters and treatment success.
METHODS
We conducted a retrospective cohort study of women with early pregnancy failure treated with misoprostol from 2006 to 2021. The success rate of misoprostol treatment was compared between patients with history of retained placenta including women who underwent manual lysis of the placenta following delivery or patients who were found to have retained products of conception during their post-partum period (study group) and patients without such history (controls). Demographic, clinical, and sonographic characteristics as well as treatment outcomes were compared between the groups.
RESULTS
A total of 271 women were included in the study (34 women in the study group compared to 237 women in the control group). Two-hundred and thirty-three women (86.0%) presented with missed abortion, and 38 (14.0%) with blighted ovum. Success rates of misoprostol treatment were 61.8% and 78.5% for the study and control groups, respectively (p = 0.032). Univariate analysis performed comparing successful vs. failed misoprostol treatment showed advanced age, gravidity, parity and gestational sac size (mm) on TVUS were associated with higher misoprostol treatment failure rate. Following a multivariate logistic regression model these variables did not reach statistical significance.
CONCLUSION
Women who have an event of retained placenta following childbirth appear to have decreased success rate of treatment with misoprostol for early pregnancy failure. Larger studies are needed to confirm this finding.
Topics: Pregnancy; Humans; Female; Misoprostol; Abortifacient Agents, Nonsteroidal; Placenta, Retained; Retrospective Studies; Abortion, Spontaneous; Treatment Outcome; Pregnancy Trimester, First
PubMed: 37794425
DOI: 10.1186/s12905-023-02666-9 -
Journal of Clinical Medicine Sep 2023The main aim of our study involves the analysis of reasons and risk factors for perioperative treatment discontinuation in patients with symptomatic uterine fibroids...
Occurrence and Risk Factors for Perioperative Treatment Discontinuation during Magnetic Resonance-Guided High-Intensity Focused Ultrasound (MR-HIFU) Therapy in Symptomatic Uterine Fibroids-A Retrospective Case-Control Study.
BACKGROUND
The main aim of our study involves the analysis of reasons and risk factors for perioperative treatment discontinuation in patients with symptomatic uterine fibroids (UFs) who were qualified for magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) and in whom the procedure was discontinued.
METHODS
The presented research included 372 women who were primarily eligible for MR-HIFU, but the procedure was interrupted. The reasons and risk factors for treatment discontinuation were analyzed. A statistical comparison of two cohorts (patients in whom the treatment was discontinued and completed) was conducted based on epidemiological factors, UF characteristics and the implementation of uterotonics.
RESULTS
The mean discontinuation rate was 18.28% ( = 68). The main reason was the malposition of the intestines (52.94% of all cases). The thermoablation of subserosal UFs was a statistically significant risk factor of perioperative treatment discontinuation (OR 4.62, CI 95% 2.04-10.56), while the therapy of intramural UFs considerably decreased the risk (OR 0.21, CI 95% 0.08-0.51). The volume of the targeted UF was negatively correlated with the risk of discontinuation (OR 0.991, CI 95% 0.986-0.996). Augmentation with oxytocin, but not misoprostol, during the procedure significantly decreased the risk of potential discontinuation (OR 0.15, CI 95% 0.045-0.387, < 0.001).
CONCLUSION
Although the discontinuation rate seems to be relatively low, further prospective randomized trials are needed to confirm our results. The establishment of particular eligibility criteria for the treatment is a crucial issue in this area. Resigning from the procedure in cases at a high risk of discontinuation might increase patient safety and shorten the time to introduce the most appropriate therapy.
PubMed: 37762939
DOI: 10.3390/jcm12185999 -
BMC Medical Research Methodology Sep 2023Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample. This paper, which reports a pilot study within a randomised controlled trial of induction of labour, reports the feasibility, and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index, a new mixed qualitative / quantitative PREM tool.
METHODS
The single-sheet PaGES Index was completed by hypertensive pregnant women in two hospitals in Nagpur, India before and after taking part in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) randomised controlled trial. Participants recorded aspects of the impending birth they considered most important, and then ranked them. After the birth, participants completed the PaGES Index again, this time also scoring their satisfaction with each item. Forms were completed on paper in the local language or in English, supported by Research Assistants. Following translation (when needed), responses were uploaded to a REDCap database, coded in Excel and analysed thematically. A formal qualitative evaluation (qMOLI) was also conducted to obtain stakeholder perspectives of the PaGES Index and the wider trial. Semi-structured interviews were conducted with participants, and focus groups with researchers and clinicians. Data were managed using NVivo 12 software and analysed using the framework approach.
RESULTS
Participants and researchers found the PaGES Index easy to complete and administer; mothers valued the opportunity to speak about their experience. Qualitative analysis of the initial 68 PaGES Index responses identified areas of commonality and difference among participants and also when comparing antenatal and postnatal responses. Theme citations and associated comments scores were fairly stable before and after the birth. The qMOLI phase, comprising 53 one-to-one interviews with participants and eight focus groups involving 83 researchers and clinicians, provided support that the PaGES Index was an acceptable and even helpful means of capturing participant perspectives.
CONCLUSIONS
Subjective participant experiences are an important aspect of clinical trials. The PaGES Index was found to be a feasible and acceptable measure that unites qualitative research's explanatory power with the comparative power of quantitative designs. It also offers the opportunity to conduct a before-and-after evaluation, allowing researchers to examine the expectations and actual experiences of all clinical trial participants, not just a small sub-sample. This study also shows that, with appropriate research assistant input, the PaGES Index can be used in different languages by participants with varying literacy levels.
TRIAL REGISTRATION
Clinical Trials.gov (21/11/2018) (NCT03749902).
Topics: Humans; Female; Pregnancy; Quality of Life; Pilot Projects; Pregnant Women; Mothers; Personal Satisfaction
PubMed: 37759174
DOI: 10.1186/s12874-023-02016-1 -
Gels (Basel, Switzerland) Aug 2023The goal of this study was to make pH-sensitive HPMC/Neocel C19-based interpenetrating polymeric networks (IPNs) that could be used to treat different diseases. An...
Novel Hydrolytic Degradable Crosslinked Interpenetrating Polymeric Networks (IPNs): An Efficient Hybrid System to Manage the Controlled Release and Degradation of Misoprostol.
PURPOSE
The goal of this study was to make pH-sensitive HPMC/Neocel C19-based interpenetrating polymeric networks (IPNs) that could be used to treat different diseases. An assembled novel carrier system was demonstrated in this study to achieve multiple functions such as drug protection and self-regulated release.
METHODS
Misoprostol (MPT) was incorporated as a model drug in hydroxyl-propyl-methylcellulose (HPMC)- and Neocel C19-based IPNs for controlled release. HPMC- and Neocel C19-based IPNs were fabricated through an aqueous polymerization method by utilizing the polymers HPMC and Neocel C19, the initiator ammonium peroxodisulfate (APS), the crosslinker methylenebisacrylamide (MBA), and the monomer methacrylic acid (MAA). An IPN based on these materials was created using an aqueous polymerization technique. Samples of IPN were analyzed using scanning electron microscopy (SEM), atomic force microscopy (AFM), differential scanning calorimetry (DSC), thermal analysis (TGA), and powder X-ray diffraction (PXRD). The effects of the pH levels 1.2 and 7.4 on these polymeric networks were also studied in vitro and through swelling experiments. We also performed in vivo studies on rabbits using commercial tablets and hydrogels.
RESULTS
The thermal stability measured using TGA and DSC for the revised formulation was higher than that of the individual components. Crystallinity was low and amorphousness was high in the polymeric networks, as revealed using powder X-ray diffraction (PXRD). The results from the SEM analysis demonstrated that the surface of the polymeric networks is uneven and porous. Better swelling and in vitro results were achieved at a high pH (7.4), which endorses the pH-responsive characteristics of IPN. Drug release was also increased in 7.4 pH (80% in hours). The pharmacokinetic properties of the drugs showed improvement in our work with hydrogel. The tablet MRT was 13.17 h, which was decreased in the hydrogels, and its AUC was increased from 314.41 ng h/mL to 400.50 ng h/mL in hydrogels. The blood compatibility of the IPN hydrogel was measured using different weights (100 mg, 200 mg, 400 mg, and 600 mg; 5.34%, 12.51%, 20.23%, and 29.37%, respectively).
CONCLUSIONS
As a result, IPN composed of HPMC and Neocel C19 was successfully synthesized, and it is now possible to use it for the controlled release of MPT.
PubMed: 37754378
DOI: 10.3390/gels9090697 -
BMJ Open Sep 2023To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We... (Randomized Controlled Trial)
Randomized Controlled Trial
Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion.
OBJECTIVES
To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.
DESIGN
Randomised controlled trial with 1:1 allocation.
SETTING
Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.
PARTICIPANTS
The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.
PRIMARY AND SECONDARY OUTCOME MEASURES
Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.
SECONDARY OUTCOMES
satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.
RESULTS
Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).
CONCLUSIONS
Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.
TRIAL REGISTRATION NUMBER
NCT04139382.
Topics: Pregnancy; Humans; Female; Utah; COVID-19; Abortion, Induced; Abortion, Spontaneous; Referral and Consultation
PubMed: 37709327
DOI: 10.1136/bmjopen-2023-073630 -
Infectious Diseases and Therapy Sep 2023Misoprostol is widely used for medication abortion and postpartum hemorrhage. However, it has been associated with the adverse effect of fever, which can pose challenges...
INTRODUCTION
Misoprostol is widely used for medication abortion and postpartum hemorrhage. However, it has been associated with the adverse effect of fever, which can pose challenges in management and potentially contribute to unnecessary antibiotic use. The incidence of misoprostol-induced fever in the context of medical abortion has not been extensively studied.
METHODS
This retrospective cohort study aimed to determine the incidence of fever following misoprostol administration at a tertiary care hospital in Saudi Arabia. The study included female patients who received misoprostol for pregnancy termination or management of missed or incomplete abortion between January 2017 and December 2019. Data on demographics, misoprostol dosage and route, fever characteristics, outcome of abortion, and antibiotic use were collected. Statistical analysis was preformed using appropriate tests.
RESULTS
A total of 213 patients were included in the study. The incidence of fever post-misoprostol administration was 8%. Patients who developed fever had a higher gestational age and received higher doses of misoprostol. However, no significant associations were found between other patient variables and fever incidence. Antibiotic therapy was administered to a almost half of the patients who developed fever post-misoprostol but was determined to be unnecessary in all cases.
CONCLUSION
This study contributes to the understanding of misoprostol-induced fever in the context of medical abortion. Further research is needed to explore strategies for reducing unnecessary antibiotic use in this population.
PubMed: 37704800
DOI: 10.1007/s40121-023-00865-3 -
Pakistan Journal of Medical Sciences 2023To determine Maternal and Fetal outcome in women undergoing induction of labour with low dose misoprostol.
OBJECTIVE
To determine Maternal and Fetal outcome in women undergoing induction of labour with low dose misoprostol.
METHOD
A cross-sectional study was carried out to determine the efficacy of Misoprostol for induction of labor (IOL) in MTI, Lady Reading Hospital (LRH), Peshawar from 21st January to 31st December 2021. All pregnant women with singleton pregnancy and cephalic presentation admitted for Induction of Labor were included in the study. Maternal and Fetal outcome was noted. Induction of labor was started with 25 micrograms of Misoprostol, repeated every six hours depending on Bishop Score.
RESULTS
Three hundred and thirty-seven women were included in this study. The majority of females (76%) were in 18-35 years age group. In 92.3% of females, the Bishop score was less than six. The maximum number of females (33.5%) delivered after eight hours of IOL. Sixty-six (66.46%) of females had gestational age of 37-40 weeks. Premature rupture of membranes was the most common indication (32.9%). Three doses of misoprostol were required in 31.2% of females. Only 5.6% of females required six doses of misoprostol for induction. With Misoprostol 85.1% of females delivered spontaneously, 2.37% required forceps delivery, 1.7% required vacuum delivery, and 10.68% delivered by Caesarean Section. APGAR score was 8 /10 in 84% of neonates at birth. Eighty-seven %(87.8%) of neonates did not require NICU admission.
CONCLUSION
Misoprostol is a safe medicine to be used to induce labor in females. It can help shorten the duration of labor, with good fetomaternal outcome.
PubMed: 37680840
DOI: 10.12669/pjms.39.5.7072 -
The Journal of International Medical... Aug 2023To compare the effects on feto-maternal outcomes of expectant versus active management for premature rupture of membranes (PROM) at term. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To compare the effects on feto-maternal outcomes of expectant versus active management for premature rupture of membranes (PROM) at term.
METHODS
This was a prospective randomized (1:1) controlled study involving 86 pregnant-women who received either expectant management (n = 43) or active management with misoprostol (n = 43) for PROM at term. Primary outcome was route of delivery. Secondary outcomes were: PROM to presentation interval; latency period; PROM to delivery interval; recruitment to delivery interval; labour and delivery complications.
RESULTS
Baseline-characteristics were similar between groups. There was no significant difference between active and expectant groups in mean PROM to presentation/admission, or PROM to delivery. However, mean latency period (11.1 ± 7.3 hours vs 8.8 ± 5.5 hours) and mean recruitment to delivery intervals after PROM (14.7 ± 5.2 hours vs 11.8 ± 5.0 hours) were significantly shorter for the active group compared with the expectant group. Although the rate of caesarean section was less in expectant management group (21%) compared with the active management group (30%), the difference was not statistically significant. There were no significant differences between groups in delivery or perinatal complications.
CONCLUSION
Active and expectant management for PROM at term gave comparable outcomes in terms of methods of delivery and complications. However, active management significantly shortened the latency period and induction to delivery intervals compared with expectant management. Pan-African-trial-registry-(PACTR)-approval-number PACTR202206797734088.
Topics: Female; Humans; Pregnancy; Cesarean Section; Prospective Studies; Research Design; Watchful Waiting; Fetal Membranes, Premature Rupture
PubMed: 37656970
DOI: 10.1177/03000605231195451 -
The Journal of Maternal-fetal &... Dec 2023To explore the suitable regimens of induced termination of second-trimester pregnancy in women with prior cesareans.
OBJECTIVE
To explore the suitable regimens of induced termination of second-trimester pregnancy in women with prior cesareans.
METHODS
A total of 204 s-trimester pregnant women with prior cesareans at the Third Affiliated Hospital of Zhengzhou University from January 2019 to December 2020 were included in this retrospective study. Group A included pregnant women who were administered mifepristone with misoprostol, Group B included those administering mifepristone with misoprostol as well as a transcervical Cook double-balloon catheter, Group C included those receiving mifepristone with an intra-amniotic injection of ethacridine lactate, and Group D included those receiving mifepristone, transcervical Cook double-balloon catheter, and intra-amniotic injection of ethacridine lactate. Their characteristics, clinical outcomes, and complications among the four groups were compared.
RESULTS
All women had similar profiles in maternal age, gravidity, and previous cesarean delivery ( > .05). There was no significant difference in successful abortion among the four groups ( > .05). Group C had a significantly shorter induction-to-abortion interval than Group D ( < .01). The blood loss after abortion at 2 h in Group B was much less than Group A ( < .05). It made a significant difference between Group B and Group D regarding the blood loss after abortion at 2 h ( < .01). With regard to total incidences of adverse reactions, there were much fewer in the group B than the group A ( < .05).
CONCLUSION
The four regimens are all effective for the termination of second-trimester pregnancy in women with prior cesareans. The use of transcervical Cook double-balloon could reduce the risks caused by misoprostol, and the combination of these is feasible to induce second-trimester pregnancy termination in women with prior cesareans.
Topics: Pregnancy; Female; Humans; Pregnancy Trimester, Second; Cesarean Section; Ethacridine; Mifepristone; Misoprostol; Retrospective Studies
PubMed: 37654101
DOI: 10.1080/14767058.2023.2249187 -
BMJ Global Health Aug 2023Service inclusion in a country's health benefit package (HBP) is an important milestone towards universal health coverage. This study aimed to explore HBP inclusion of...
INTRODUCTION
Service inclusion in a country's health benefit package (HBP) is an important milestone towards universal health coverage. This study aimed to explore HBP inclusion of abortion interventions globally.
METHODS
Secondary analysis of the WHO HBP survey, in which officially nominated survey focal points were asked which interventions were included within the HBP of their country or area's largest government health financing scheme. Abortion inclusion was compared by region, income, legal status of abortion and HBP design process variables. Abortion inclusion was compared with other sexual and reproductive health (SRH) services.
RESULTS
Below half (45%) reported that abortion is included, but treatment of complications from unsafe abortion was more commonly included (63%). Fewer fully included essential abortion medications (22% mifepristone, 42% misoprostol). Abortion was less commonly included than any other SRH service in the survey. Unlike most SRH services, higher cost, higher technology care to treat complications of unsafe abortion was more commonly included than the relatively lower cost, lower technology service of induced abortion. Higher-income contexts and less restrictive legal environments had higher abortion inclusion. Some contexts had additional restrictions, with abortion inclusion dependent on the patient's reason for seeking care.
CONCLUSION
This global survey finds that abortion services and medications are often not included within HBPs, while treatment of complications from unsafe abortion is more commonly included. There are opportunities to improve HBP abortion inclusion across different legal contexts, which can improve health outcomes and reduce the need for higher cost treatment of complications from unsafe abortion.
Topics: Female; Pregnancy; Humans; Abortion, Induced; Health Surveys; Drugs, Essential; Financing, Government; World Health Organization
PubMed: 37643800
DOI: 10.1136/bmjgh-2023-012321