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Journal of Obstetrics and Gynaecology... Jun 2024To evaluate the safety and efficacy of first-trimester "No Touch" medication abortion programs at 2 clinics in Toronto, Ontario during their early implementation in...
OBJECTIVES
To evaluate the safety and efficacy of first-trimester "No Touch" medication abortion programs at 2 clinics in Toronto, Ontario during their early implementation in response to the COVID-19 pandemic.
METHODS
This retrospective study included all patients who underwent virtual consultation for mifepristone-misoprostol medication abortion between April 2020-August 2022 at 2 reproductive health clinics. In response to the pandemic, "No Touch" abortion protocols have been developed that align with the Canadian Protocol for the Provision of Medical Abortion via Telemedicine. Records were reviewed for demographic information, clinical course, investigations required, confirmation of complete abortion and adverse events. The primary outcome was complete medication abortion, defined as expulsion of the pregnancy without requiring uterine aspiration.
RESULTS
A total of 277 patients had abortions initiated in the "No Touch" or "Low Touch" care pathways and had sufficient follow-up to determine outcomes. Of these patients, 92.8% (95% CI 89.7%-95.8%) had a complete medication abortion (n = 257) and 76.1% (n = 159) remained "No Touch" throughout their care. Investigations were performed for 102 participants before or after their abortion, classifying them as "Low Touch". Nineteen patients (6.9%) underwent uterine aspiration. The rate of adverse events was low, with 1 case of a missed ectopic pregnancy and 1 patient requiring hospitalization for endometritis.
CONCLUSIONS
"No Touch" provision of mifepristone-misoprostol medication abortion care was safe and effective with outcomes comparable to previous studies. These results provide evidence for the efficacy and safety of a "No Touch" approach in the Canadian context, which has the potential to reduce barriers to accessing abortion care.
Topics: Humans; Female; COVID-19; Abortion, Induced; Pregnancy; Retrospective Studies; Adult; Ontario; Mifepristone; Pandemics; SARS-CoV-2; Misoprostol; Pregnancy Trimester, First; Telemedicine; Abortifacient Agents, Nonsteroidal; Coronavirus Infections; Betacoronavirus; Pneumonia, Viral; Young Adult
PubMed: 38458271
DOI: 10.1016/j.jogc.2024.102429 -
American Journal of Perinatology Mar 2024Postpartum hemorrhage (PPH) protocols improve patient safety and reduce utilization of blood products; however, few data exist on sustainability of PPH checklist use,...
OBJECTIVE
Postpartum hemorrhage (PPH) protocols improve patient safety and reduce utilization of blood products; however, few data exist on sustainability of PPH checklist use, how use affects care delivery, and variation of use among patient subgroups. This study aimed to (1) examine compliance with PPH checklist use during vaginal deliveries, (2) evaluate whether checklist use varied by patient and/or care team characteristics, and (3) evaluate whether checklist use was associated with increased use of recommended medications/interventions.
STUDY DESIGN
This was a quality improvement study performed from April 2021 through June 2023. A multidisciplinary team developed a revised PPH checklist and used quality improvement methodology to increase checklist use following vaginal birth. Data were collected from medical records and clinician survey. Control charts were generated to track checklist use and evaluate special cause variation. Chi-square tests and logistic regression were used to evaluate variation in medications/interventions and across subgroups.
RESULTS
During the study period, there were 342 cases of PPH at the time of vaginal birth. The checklist was used in 67% of PPH cases during the 20-month period after implementation in a setting where no checklist was previously being used. We found no statistically significant differences in checklist use by patient or health care team characteristics. Use of tranexamic acid, carboprost, and misoprostol were significantly associated with checklist use.
CONCLUSION
This study demonstrated successful implementation of a checklist protocol where no checklist was previously being used, with sustained use in an average of 67% of PPH cases over 20 months. Checklist use was consistent across subgroups and was associated with higher use of interventions shown to lower blood loss.
KEY POINTS
· Our study showed sustainability of PPH checklist use over a 20-month period.. · PPH checklist use was associated with increased use of interventions known to reduce blood loss.. · Checklist was used consistently across patient subgroups; may help address inequities in obstetric outcomes..
PubMed: 38452794
DOI: 10.1055/a-2282-8923 -
BJOG : An International Journal of... Aug 2024Induction of labour (IOL) is common practice and different methods carry different effectiveness and safety profiles. (Meta-Analysis)
Meta-Analysis Comparative Study Review
Vaginal misoprostol versus vaginal dinoprostone for cervical ripening and induction of labour: An individual participant data meta-analysis of randomised controlled trials.
BACKGROUND
Induction of labour (IOL) is common practice and different methods carry different effectiveness and safety profiles.
OBJECTIVES
To compare the effectiveness, and maternal and perinatal safety outcomes of IOL with vaginal misoprostol versus vaginal dinoprostone using individual participant data from randomised clinical trials.
SEARCH STRATEGY
The following databases were searched from inception to March 2023: CINAHL Plus, ClinicalTrials.gov, Cochrane Pregnancy and Childbirth Group Trial Register, Ovid Embase, Ovid Emcare, Ovid MEDLINE, Scopus and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).
SELECTION CRITERIA
Randomised controlled trials (RCTs), with viable singleton gestation, no language restrictions, and all published and unpublished data.
DATA COLLECTION AND ANALYSIS
An individual participant data meta-analysis was carried out.
MAIN RESULTS
Ten of 52 eligible trials provided individual participant data, of which two were excluded after checking data integrity. The remaining eight trials compared low-dose vaginal misoprostol versus dinoprostone, including 4180 women undergoing IOL, which represents 32.8% of all participants in the published RCTs. Of these, 2077 were assigned to low-dose vaginal misoprostol and 2103 were assigned to vaginal dinoprostone. Compared with vaginal dinoprostone, low-dose vaginal misoprostol had a comparable rate of vaginal birth. Composite adverse perinatal outcomes did not differ between the groups. Compared with vaginal dinoprostone, composite adverse maternal outcomes were significantly lower with low-dose vaginal misoprostol (aOR 0.80, 95% CI 0.65-0.98, P = 0.03, I = 0%).
CONCLUSIONS
Low-dose vaginal misoprostol and vaginal dinoprostone for IOL are comparable in terms of effectiveness and perinatal safety. However, low-dose vaginal misoprostol is likely to lead to a lower rate of composite adverse maternal outcomes than vaginal dinoprostone.
Topics: Humans; Female; Labor, Induced; Misoprostol; Pregnancy; Dinoprostone; Oxytocics; Randomized Controlled Trials as Topic; Administration, Intravaginal; Cervical Ripening
PubMed: 38425020
DOI: 10.1111/1471-0528.17794 -
Obstetrics and Gynecology May 2024To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy.
OBJECTIVE
To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy.
METHODS
The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes.
RESULTS
Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups.
CONCLUSION
Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov , NCT0210094.
Topics: Pregnancy; Humans; Female; Adult; Young Adult; Uterine Myomectomy; Pregnancy Outcome; Abortion, Spontaneous; Prospective Studies; Uterine Neoplasms; Leiomyoma; Radiofrequency Ablation; Laparoscopy
PubMed: 38422502
DOI: 10.1097/AOG.0000000000005548 -
International Journal of Gynaecology... May 2024Retraction: Ali, M. K., Eman, S. M., Abdel-Aleem, M. A., Sobh, A. M. A. Misoprostol versus expectant management in women with incomplete first-trimester miscarriage...
Retraction: Ali, M. K., Eman, S. M., Abdel-Aleem, M. A., Sobh, A. M. A. Misoprostol versus expectant management in women with incomplete first-trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial. International Journal of Gynecology & Obstetrics, 154: 558-564. https://doi.org/10.1002/ijgo.13652. The above article, published online on 22 February 2021 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Professor Michael Geary, the International Federation of Gynecology and Obstetrics, and John Wiley and Sons Ltd. Concerns were raised by a third party about inconsistencies in the data and study design of this article and the authors were asked to provide an explanation. Following the authors' response, an independent review concluded that there were inconsistencies in the sample sizes reported in the manuscript, and between the manuscript and the trial registry. There was also a change in the primary outcome in the trial registry that was not reported in the manuscript. Therefore, the parties agreed that the article must be retracted. The authors were notified about the retraction but did not respond.
PubMed: 38419152
DOI: 10.1002/ijgo.15450 -
Ecancermedicalscience 2023Most cervical cancers develop in the transformation zone (TZ). Type 3 TZs, where the full circumference of the squamocolumnar junction (SCJ) is not visible pose problems...
Most cervical cancers develop in the transformation zone (TZ). Type 3 TZs, where the full circumference of the squamocolumnar junction (SCJ) is not visible pose problems during cervical screening with visual inspection methods, as (pre)cancerous lesions may be missed. Several practical strategies can be implemented to convert type 3 TZs into TZ 1 or TZ 2, including the use of an endocervical speculum or hygroscopic cervical dilators, opening the vaginal speculum more widely, skillful use of cotton-tipped applicators, performing colposcopy in midcycle, and use of oral or vaginal misoprostol and estrogen to 'ripen' the cervix. With the 2011 International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology, settings with better resources to manipulate the cervix for a better view of the endocervical canal may assign patients to different categories from those in low-resource settings during a colposcopic examination. Here, we propose a colposcopic revision to the current IFCPC classification by segregating TZ 2 according to the extent of endocervical involvement and TZ 3 according to whether any attempt is made to open the endocervical canal, if such attempt(s) were successful, and the extent to which the practitioner can visualise parts of the uterine cervix beyond the border of the SCJ in the endocervical canal. In this proposed reclassification, TZ 2A has no part of the SCJ extending beyond 5 mm into the endocervical canal, whereas TZ 2B has part or all of the SCJ extending beyond 5 mm into the endocervical canal. TZ 3 is further subclassified into TZ 3A if the practitioner does not attempt to open the endocervical canal or the endocervical canal is opened, but not beyond 5 mm and TZ 3B if the full circumference cannot be visualised after opening the endocervical canal beyond 5 mm. We believe this revision will improve and better standardise the classification of TZ types, with huge implications for practice in low-resource settings, due to limited options for referral and treatment, to reduce the risk of missed cervical cancers and suboptimal treatment resulting from ablating lesions that extend too far into the endocervical canal.
PubMed: 38414959
DOI: 10.3332/ecancer.2023.1612 -
Obstetrics & Gynecology Science May 2024The study aimed to compare the effectiveness and side effects of 600 μg of oral Misoprostol with 10 international units (IU) intramuscular oxytocin in managing the...
OBJECTIVE
The study aimed to compare the effectiveness and side effects of 600 μg of oral Misoprostol with 10 international units (IU) intramuscular oxytocin in managing the third stage of labor.
METHODS
This open-label, randomized controlled trial included 260 low-risk women in the second stage of labor with anticipated vaginal delivery. They were randomly assigned, to receive either 600 μg of misoprostol orally or 10 IU of oxytocin intramuscularly. The primary outcomes were blood loss during delivery and incidence of postpartum hemorrhage, evaluated using intention-to-treat analysis. Significance was set at P≤0.05.
RESULTS
Baseline characteristics were similar in both groups (P>0.05). The misoprostol group had a significantly lower blood loss than that of the oxytocin group (306.57±176.44 mL vs. 349.37±135.50 mL; relative difference, -12.251 [95% confidence intervals [CI], -22.528 to -1.575]; P=0.012). Incidence of postpartum hemorrhage was similar in both the groups (relative risk [RR], 0.952 [95% CI, 0.543 to 0.671]; P=0.865). Additional oxytocic therapy requirement was also comparable (RR, 1.143 [95% CI, 0.671 to 1.947]; P=0.623). Nausea, shivering, and mean increase in temperature were significantly more common in the misoprostol group than in the oxytocin-parturient group.
CONCLUSION
In this study, 600 μg oral misoprostol was superior to intramuscular 10 IU oxytocin in reducing blood loss at birth, and equally effective in preventing postpartum hemorrhage. However, misoprostol exhibited more side effects compared to that of oxytocin.
PubMed: 38409787
DOI: 10.5468/ogs.23128 -
Nigerian Journal of Clinical Practice Feb 2024Intrauterine foetal death (IUFD) is an unpleasant pregnancy outcome and prompt delivery of the dead foetus is usually desired by mothers. Unfortunately, spontaneous... (Randomized Controlled Trial)
Randomized Controlled Trial
A Comparison of the Efficacy and Safety of Mifepristone and Misoprostol Versus Misoprostol alone for Induction of Labour in Nigerian Women with Intrauterine Fetal Death: A Triple Blind Randomized Controlled Trial.
BACKGROUND
Intrauterine foetal death (IUFD) is an unpleasant pregnancy outcome and prompt delivery of the dead foetus is usually desired by mothers. Unfortunately, spontaneous labour and delivery may not occur early and prolonged retention of the dead foetus in utero is life-threatening. Many of the agents currently used for the induction of labour may result in a prolonged delivery process.
OBJECTIVES
To compare the efficacy and safety of mifepristone and misoprostol versus misoprostol alone for induction of labour in women with intrauterine foetal death.
MATERIALS AND METHODS
This was a triple-blind randomized controlled trial. Eighty women were randomized into two groups. The intervention group received a single oral dose of 200 mg mifepristone, followed by 6-hourly 50 μg misoprostol vaginal insertion, after 24-hour intervals. The control group received a placebo, followed by 6-hourly 50 μg misoprostol vaginal insertion, after 24-hour intervals. The primary outcome measure was the induction to delivery interval.
RESULTS
Maternal age, gestational age, parity and pre-induction bishop's score were comparable between the two groups. The mean induction to the delivery interval in the intervention group was significantly less in the intervention group than the control group (18.78 ± 6.51 hours versus 37.10 ± 10.10; P < 0.001). The total dose of misoprostol required for induction of labour; the need for oxytocin augmentation of labour; and the observed side effects of misoprostol were all significantly less in intervention group than control group (P < 0.001; P < 0.01; and P = 0.03, respectively).
CONCLUSION
The combination of mifepristone and misoprostol has greater efficacy and better safety profile than the use of misoprostol alone for induction of labour. This combination should be considered when induction of labour is indicated for IUFD.
Topics: Female; Humans; Pregnancy; Administration, Intravaginal; Fetal Death; Labor, Induced; Mifepristone; Misoprostol; Oxytocics; Pregnancy Outcome; Drug Combinations
PubMed: 38409142
DOI: 10.4103/njcp.njcp_786_22 -
American Journal of Perinatology Aug 2021
Corrigendum: Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial.
PubMed: 38382635
DOI: 10.1055/a-2273-2289