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BioMed Research International 2022To compare the maternal and neonatal outcomes of pregnant women who had labor induction with intravaginal misoprostol or had spontaneous labor in our clinic. . The...
PURPOSE
To compare the maternal and neonatal outcomes of pregnant women who had labor induction with intravaginal misoprostol or had spontaneous labor in our clinic. . The records of 213 pregnant women, who were followed up in Acibadem Maslak University Hospital for vaginal delivery between June 2021 and December 2021, were retrospectively evaluated. The pregnant women, who gave birth, were divided into 3 groups as follows: spontaneous labor (SL), those induced by a single dose of misoprostol (SDM), and those induced by multiple doses of misoprostol (MDM). The groups were compared in terms of delivery type, the vaginal birth rate within 12 hours, need for intervention, duration of the second stage of labor, cesarean section ratio due to fetal distress, time from the last dose to delivery, and 1st and 5th minute APGAR scores.
RESULTS
Among the primiparous pregnant women, 84.7% of SL group, 65.2% of SDM group, and 37% MDM group delivered vaginally within 12 hours ( < 0.05). The time from the last misoprostol dose to delivery was also statistically significantly shorter in pregnant women, who received a single dose of misoprostol (483 vs. 720 min, respectively). When the hospitalization time was evaluated, in the SDM group, the MDM group, and the SL group, it was found to be 611, 831, and 379 min, respectively. In multiparous pregnant women, the hospitalization time was 735 min in the SDM group, 494 min in the MDM group, and 261.5 min in the SL group ( < 0.05). Other than the hospitalization time, when the aforementioned variables were studied in multiparous pregnant women, no statistically significant difference among groups was observed ( > 0.05).
CONCLUSION
Intravaginal misoprostol seems to be a promising medical agent for labor induction due to its high delivery rates within 12 hours and the absence of negative fetal outcomes, its ease of storage, and affordable cost.
Topics: Infant, Newborn; Female; Pregnancy; Humans; Misoprostol; Oxytocics; Cesarean Section; Retrospective Studies; Pregnancy Outcome; Administration, Intravaginal; Labor, Induced
PubMed: 36531654
DOI: 10.1155/2022/2826927 -
Obstetrics and Gynecology Jul 2019To evaluate whether cervical ripening with oral misoprostol increases cesarean delivery risk and prolongs time to vaginal delivery compared with vaginal misoprostol in a... (Comparative Study)
Comparative Study
OBJECTIVE
To evaluate whether cervical ripening with oral misoprostol increases cesarean delivery risk and prolongs time to vaginal delivery compared with vaginal misoprostol in a predominantly overweight population.
METHODS
This single center, retrospective cohort study was performed at a tertiary care academic medical center and compared labor induction outcomes with vaginal misoprostol to outcomes with oral misoprostol after a complete institutional shift to oral misoprostol. Labor induction using 25 micrograms vaginal misoprostol in 2013-2014 was compared with 50 micrograms oral misoprostol in 2014-2015. The primary outcome was cesarean delivery. Secondary outcomes included time to vaginal delivery, uterine tachysystole, maternal hemorrhage, and composite adverse neonatal outcomes. Demographics and outcomes were analyzed using standard statistical tests. Multivariable regression models accounting for potential confounders were created for the primary and secondary outcomes with adjusted odds ratios (aOR) as the measures of effect.
RESULTS
There were 138 women in the oral and 138 women in the vaginal misoprostol groups. In the overall cohort, the median (interquartile range) body mass index was 31.7 (28.2-36.8) and most women (72%) were of either black or Hispanic race or ethnicity. The frequency of cesarean delivery was higher in the oral than the vaginal misoprostol group (32% vs 21%; P=.04). The adjusted odds of cesarean was higher with oral misoprostol (aOR 2.01; 95% CI 1.07-3.76). Among nulliparous women, the frequency of cesarean delivery was 41% in the oral and 28% in the vaginal misoprostol groups (aOR 2.79; 95% CI 1.26-6.19). Women had a longer time to vaginal delivery in the oral compared with vaginal misoprostol group (41 vs 31 hours respectively, P=.01). Tachysystole occurred more frequently with vaginal misoprostol (20% vs 11%; P=.04).
CONCLUSION
Compared with vaginal misoprostol, oral misoprostol may be associated with increased risk of cesarean delivery and longer time to vaginal delivery.
Topics: Administration, Intravaginal; Administration, Oral; Adult; Cesarean Section; Cohort Studies; Delivery, Obstetric; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Retrospective Studies; Risk Factors; Treatment Outcome
PubMed: 31188317
DOI: 10.1097/AOG.0000000000003274 -
Nigerian Journal of Clinical Practice Apr 2023Despite using a tourniquet to reduce bleeding during abdominal myomectomy, the procedure is still complicated by significant intraoperative bleeding. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Despite using a tourniquet to reduce bleeding during abdominal myomectomy, the procedure is still complicated by significant intraoperative bleeding.
AIM
To determine whether misoprostol and tourniquet compared with tourniquet alone would significantly reduce bleeding during abdominal myomectomy at two tertiary hospitals in Enugu.
MATERIALS AND METHODS
This study is an open-label randomized controlled trial. A total of 126 consenting participants were recruited from women booked for abdominal myomectomy at the study centers over 7 months. They were randomized into groups A (vaginal misoprostol 400 μg) and B (no misoprostol) one hour before surgery. Intraoperatively, all participants had a tourniquet application. Intraoperative and postoperative blood loss was compared between the two groups. Descriptive and inferential analyses were carried out using IBM SPSS Version 22.0. A P- value of < 0.05 was considered statistically significant.
RESULTS
An intention-to-treat analysis was carried out. All 63 participants (100%) and 56 (90%) completed the study according to the protocol in groups A and B, respectively. Socio-demographic characteristics were not significantly different in both groups. The mean intraoperative blood loss in the "misoprostol group" (522.6 ± 127.91 ml) was significantly lower than in the "no-misoprostol group" (583.5 ± 186.20 ml), with P = 0.028. The difference in mean hemoglobin (g/dl) was lower in the "misoprostol group" than in the "no-misoprostol group" (1.3 ± 0.79 vs. 1.9 ± 0.89, P < 0.001). The mean 48 hours postoperative blood loss (ml) between the two groups was 323.8 ± 221.44 vs. 549.4 ± 519.72), with P = 0.001.
CONCLUSION
Among women receiving tourniquet during myomectomy in Enugu, the additional use of vaginal misoprostol 400 μg significantly reduced intraoperative blood loss.
Topics: Female; Humans; Uterine Myomectomy; Misoprostol; Blood Loss, Surgical; Leiomyoma; Nigeria; Postoperative Hemorrhage
PubMed: 37203110
DOI: 10.4103/njcp.njcp_526_22 -
The Lancet. Global Health Oct 2022To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda.
BACKGROUND
To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of treatment for incomplete second trimester abortion with misoprostol, comparing care provision by midwives with that provided by physicians in Uganda.
METHODS
Our multicentre, randomised, controlled, equivalence trial undertaken in 14 health facilities in Uganda recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned (1:1) women to clinical assessment and treatment by either midwife or physician. The randomisation sequence was computer generated, in blocks of four to 12, and stratified for study site. Participants received sublingual misoprostol (400 μg once every 3 h for up to five doses). The study was not concealed from the health-care providers and study participants. Primary outcome was complete abortion within 24 h that did not require surgical evacuation. Analysis was per-protocol and intention to treat; the intention-to-treat population consisted of women who were randomised, received at least one dose of misoprostol, and reported primary outcome data, and the per-protocol population excluded women with unexplained discontinuation of treatment. We used generalised mixed-effects models to obtain the risk difference. The predefined equivalence range was -5% to 5%. The trial was registered at ClinicalTrials.gov, NCT03622073.
FINDINGS
Between Aug 14, 2018, and Nov 16, 2021, 1191 eligible women were randomly assigned to each group (593 women to the midwife group and 598 to the physician group). 1164 women were included in the per-protocol analysis, and 530 (92%) of 577 women in the midwife group and 553 (94%) of 587 women in the physician group had a complete abortion within 24 h. The model-based risk difference for the midwife versus physician group was -2·3% (95% CI -4·4 to -0·3), and within our predefined equivalence range (-5% to 5%). Two women in the midwife group received blood transfusion.
INTERPRETATION
Clinical assessment and treatment of second trimester incomplete abortion with misoprostol provided by midwives was equally effective and safe as when provided by physicians. In low-income settings, inclusion of midwives in the medical management of uncomplicated second trimester incomplete abortion has potential to increase women's access to safe post-abortion care.
FUNDING
Swedish Research Council and THRiVE-2.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Abortion, Induced; Female; Humans; Midwifery; Misoprostol; Physicians; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Uganda
PubMed: 36030801
DOI: 10.1016/S2214-109X(22)00312-6 -
Acta Obstetricia Et Gynecologica... Apr 2021The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9 weeks' gestation is well established. However, the upper... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9 weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion.
MATERIAL AND METHODS
We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9 weeks' gestational age with pregnancies of 9 -10 weeks or >10 weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE.
RESULTS
Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9 and >9 weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9 weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9 -10 weeks' gestation with pregnancies of >10 weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up.
CONCLUSIONS
Women who are having a medical abortion and will be taking mifepristone up to and including 10 weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10 weeks.
Topics: Abortifacient Agents; Abortion, Induced; Female; Gestational Age; Home Care Services; Humans; Mifepristone; Misoprostol; Pregnancy
PubMed: 33063314
DOI: 10.1111/aogs.14025 -
The Journal of Obstetrics and... Aug 2017The aim of this study was to evaluate the efficacy of oral misoprostol and Foley's catheter versus oral misoprostol alone for induction of labor. (Comparative Study)
Comparative Study Randomized Controlled Trial
AIM
The aim of this study was to evaluate the efficacy of oral misoprostol and Foley's catheter versus oral misoprostol alone for induction of labor.
METHODS
This open-label randomized controlled trial included 335 women requiring induction of labor. A total of 166 women were randomly allocated to induction with oral misoprostol alone and 169 women were assigned for induction with Foley's balloon catheter and oral misoprostol using a computer-generated allocation sequence. The primary outcome was rate of failure to achieve vaginal delivery within 24 h of induction.
RESULTS
The proportion of women failing to achieve vaginal delivery within 24 h in the combination group was lower (11.8% vs 28.7%, P = 0.001). When the two groups were stratified according to parity, the difference remained statistically significant only for parous women. The median induction-to-delivery interval (13.0 h vs 19 h, P = 0.000) and the median number of doses of misoprostol used (2 vs 3, P = 0.000) were lower in the combination group. The number of women who delivered vaginally in the combination group was significantly higher (91% vs 79%, P = 0.001). More neonates born to women in the misoprostol group had Apgar scores < 7 and were admitted to the neonatal intensive care unit (P = 0.016 and P = 0.007, respectively).
CONCLUSION
The rate of failure to achieve vaginal delivery within 24 h was lower with Foley's balloon and oral misoprostol as compared to oral misoprostol alone.
Topics: Adult; Catheterization; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Young Adult
PubMed: 28561987
DOI: 10.1111/jog.13354 -
Journal of Equine Veterinary Science Oct 2022Misoprostol, a synthetic PGE1, is becoming a common therapy for mares with suspected uterine tube obstruction. Recently, there have been concerns that uterine...
Misoprostol, a synthetic PGE1, is becoming a common therapy for mares with suspected uterine tube obstruction. Recently, there have been concerns that uterine administration of misoprostol induces exacerbated uterine inflammation; however, this has not been critically evaluated. This study aimed to assess the inflammatory response and potential systemic reactions after uterine administration of misoprostol, either during prebreeding or immediately after postembryo flushing. Privately owned embryo donor mares (n = 11) were randomly assigned in a crossover design to receive misoprostol (3 mL +200 µg) or sham (3 mL of lactate Ringer's solution) infusions, bilaterally deposited via deep-horn, at least 72 hours prebreeding (experiment 1) or immediately after embryo flushing (experiment 2). Each mare had one cycle for misoprostol and sham in both experiments and a breeding cycle (no sham or misoprostol) between experiments. Uterine edema, fluid accumulation, and the number of uterine PMN were assessed before each infusion and then daily for 72 hours. Uterine lavage was performed the day after each infusion across groups and experiments. Ovulation was hastened with a GnRH agonist and confirmed at 24 hour-intervals. Mares were bred with semen from one of six stallions per owner's choice. Embryo flushing was performed 8 to 9 days postovulation. In either experiment, misoprostol did not affect uterine edema or fluid accumulation (P > .05). However, both the sham and misoprostol infusions increased the number of PMN up to 48 hours postinfusion in both experiments. Embryo recoveries were similar between sham (45%, 5/11) and misoprostol cycles in experiments 1 (45%, 5/11; P > .05) and 2 (sham, 68%, 7/11; misoprostol, 45%, 5/11; P > .05). In conclusion, misoprostol did not induce exacerbated uterine inflammation in mares or systemic adverse reactions when infused prebreeding or immediately after embryo flushing.
Topics: Alprostadil; Animals; Edema; Female; Gonadotropin-Releasing Hormone; Horse Diseases; Horses; Inflammation; Lactates; Male; Misoprostol; Ringer's Solution; Uterine Diseases
PubMed: 35781026
DOI: 10.1016/j.jevs.2022.104060 -
International Journal of Gynaecology... Aug 2022To assess the cost-effectiveness of vaginal misoprostol (PGE1; 25 μg) compared with a slow-release dinoprostone (PGE2) pessary (10 μg) for labor induction due to an... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To assess the cost-effectiveness of vaginal misoprostol (PGE1; 25 μg) compared with a slow-release dinoprostone (PGE2) pessary (10 μg) for labor induction due to an unfavorable cervix at term.
METHODS
We used data from an open-label multicenter, randomized non-inferiority trial that recruited women for whom labor was induced for medical reasons. The incremental cost-effectiveness ratio was assessed from the payer's perspective, with the focus on inpatient care costs and using the cesarean deliveries avoided (CDA) rate as the primary analysis and the rate of vaginal delivery within 24 h (VD24) as the secondary analysis.
RESULTS
Analyses were based on 790 women in each group. Differences between treatment arms were the mean cost per patient of €4410 and €4399, a CDA rate of 80.1% and 77.9% and a VD24 rate of 46.1% and 59.4% for dinoprostone and misoprostol, respectively. Dinoprostone is not cost-effective according to the CDA rate and misoprostol was either a cost-effective or a dominant strategy according to the VD24.
CONCLUSION
Misoprostol and dinoprostone have equal cost management with mixed efficacy according to the clinical outcome used. Finally, misoprostol may be an attractive option for hospitals as the price is lower and it is easier to use.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01765881. URL: https://clinicaltrials.gov/ct2/show/NCT01765881. ClinicalTrialRegistrer.eu: 2011-000933-35. URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-000933-35/FR.
Topics: Administration, Intravaginal; Cost-Benefit Analysis; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pessaries; Pregnancy
PubMed: 34714938
DOI: 10.1002/ijgo.13999 -
Sexual & Reproductive Healthcare :... Jun 2023To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar.
OBJECTIVE
To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar.
METHODS
An explanatory sequential mixed methods study was conducted. Women seeking treatment for an incomplete abortion with a uterine size <12 weeks were eligible to participate in the prospective cohort including sublingual administration of 400 μg misoprostol, clinical assessment 7-10 days after administration, and patient interview. Treatment efficacy was assessed, defined as proportion of participants with complete uterine evacuation with misoprostol alone. After the cohort, provider interviews were conducted to understand how their experiences with misoprostol may have influenced cohort findings. Study sites included seventeen secondary health facilities in four townships in Yangon and Mandalay, Myanmar.
RESULTS
A total of 110 women were enrolled from July 2018 to January 2019; 96 completed follow-up. In 75 % of cases, incomplete abortion was successfully treated with misoprostol. Treatment efficacy varied significantly by region (Yangon 85 %, Mandalay 67 %; p = 0.048), driven by providers' variable comfort with misoprostol and proclivity to intervene with additional treatment. With experience, all were willing to incorporate the protocol into practice by study end. Patient acceptability and satisfaction were high.
CONCLUSION
Misoprostol is an acceptable and feasible treatment option for women seeking postabortion care at secondary facilities in Myanmar. Extensive health provider training and support systems and continued implementation experience are crucial to effectively translate clinical PAC guidelines into practice in Myanmar.
Topics: Pregnancy; Female; Humans; Misoprostol; Abortion, Incomplete; Abortifacient Agents, Nonsteroidal; Prospective Studies; Feasibility Studies; Myanmar; Patient Satisfaction; Abortion, Induced; Health Facilities
PubMed: 36842188
DOI: 10.1016/j.srhc.2023.100825 -
Journal of Medical Economics 2022Various methods exist for the induction of labor (IOL), and there is limited consensus as to optimal methods. Off-label misoprostol is recommended by the World Health... (Review)
Review
BACKGROUND
Various methods exist for the induction of labor (IOL), and there is limited consensus as to optimal methods. Off-label misoprostol is recommended by the World Health Organization (WHO) for IOL but preparing it into doses suitable for IOL lacks precision, with potential adverse outcomes if dosing is inaccurate. This study explores potential outcomes and costs associated with increased uptake of a low-dose (25 µg) oral misoprostol formulation (Angusta; Norgine BV, Amsterdam) approved for IOL, in France, Belgium, and the Netherlands.
METHODS
A literature review was undertaken to derive probabilities of delivery outcomes (vaginal, instrumental, and cesarean sections) for IOL methods, from published meta-analyses. Outcomes for oral misoprostol tablets (25 µg) were unavailable in the meta-analyses, so were estimated using data from two published retrospective cohort studies. A model was developed to predict the frequency of IOL outcomes and associated costs at the national level, across multiple scenarios. Scenarios were tested using a moderate, medium, and high increase in oral misoprostol tablet (25 µg) uptake. Market shares, costs, and induction rates were defined for each country using multiple data sources.
RESULTS
Increased uptake of oral misoprostol tablets (25 µg) was estimated to be associated with a slightly increased rate of routine vaginal deliveries, and concurrent decreases in instrumental vaginal deliveries and cesarean sections. Since routine vaginal deliveries are less costly than other delivery outcomes, increased uptake of oral misoprostol tablets (25 µg) within the IOL market has the potential to be cost-saving. These trends were predicted using 25 µg oral misoprostol tablet outcomes informed by both retrospective studies.
CONCLUSION
Preliminary outcomes suggest that oral misoprostol tablets at 25 µg per dose may improve outcomes in IOL and be cost-saving. Further study is required to validate these findings and assess the comparative efficacy of IOL methods, including oral misoprostol tablets (25 µg).
Topics: Administration, Oral; Costs and Cost Analysis; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Retrospective Studies; Tablets
PubMed: 35297743
DOI: 10.1080/13696998.2022.2053432