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Drug Design, Development and Therapy 2015Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations... (Review)
Review
Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.
Topics: Administration, Intravaginal; Adult; Cervical Ripening; Chemistry, Pharmaceutical; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Drug Delivery Systems; Drug Implants; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy
PubMed: 25960635
DOI: 10.2147/DDDT.S64227 -
Journal of Anesthesia Aug 2023
Topics: Pregnancy; Female; Humans; Cesarean Section; Japan; Oxytocin; Oxytocics
PubMed: 37086271
DOI: 10.1007/s00540-023-03194-4 -
European Journal of Obstetrics,... Sep 2022To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated the efficacy and safety of isosorbide mononitrate (IMN) in... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated the efficacy and safety of isosorbide mononitrate (IMN) in promoting cervical ripening during labour induction.
METHODS
Six major databases were searched from inception until 22 April 2021. The risk of bias of included studies was assessed. Various endpoints (n = 21) were meta-analysed, and the endpoints were pooled as mean differences (MD) or risk ratios (RR) with 95% confidence intervals (CI).
RESULTS
In total, 23 RCTs were included in this review, comprising 26 intervention arms and a total of 4305 patients (2210 and 2095 patients were allocated to the IMN and control groups, respectively). Pertaining to obstetric-related maternal outcomes, the pooled analysis showed that admission to delivery time and rate of caesarean delivery were significantly reduced in the IMN group. Moreover, the mean Bishop score and the mean change in Bishop score were significantly increased in the IMN group. Pertaining to drug-related maternal side effect outcomes, the pooled analysis showed that the rates of headache, palpitations, nausea and flushing were significantly lower in the IMN group. Pertaining to neonatal outcomes, the pooled analysis showed no significant difference between the two groups in terms of the rates of neonatal intensive care unit admission, neonatal death, fetal distress, meconium-stained water, Apgar score < 7 at 1 and 5 min, and mean Apgar score at 1 and 5 min.
CONCLUSION
IMN correlated with several obstetric-related maternal outcomes. IMN was not associated with adverse neonatal outcomes, but was associated with substantial drug-related maternal side effects.
Topics: Cervical Ripening; Female; Humans; Infant, Newborn; Isosorbide Dinitrate; Labor, Induced; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 35803111
DOI: 10.1016/j.ejogrb.2022.06.028 -
Acta Obstetricia Et Gynecologica... Apr 2021The use of oxytocin to augment labor is increasing in many low-resource settings; however, little is known about the effects of such use in contexts where resources for...
INTRODUCTION
The use of oxytocin to augment labor is increasing in many low-resource settings; however, little is known about the effects of such use in contexts where resources for intrapartum monitoring are scarce. In this study, we sought to assess the association between augmentation of labor with oxytocin and delivery outcomes.
MATERIAL AND METHODS
We conducted a cohort study in 12 public hospitals in Nepal, including all deliveries with and without augmentation of labor with oxytocin, but excluding elective cesarean sections, women with missing information on augmentation of labor, and women without fetal heart rate on admission. Bivariate and multivariate logistic regression calculating the crude and adjusted risk ratio (aRR) with corresponding 95% CI were performed, comparing (a) intrapartum stillbirth and first-day mortality (primary outcome); and (b) intrapartum monitoring, mode of delivery, postpartum hemorrhage, bag-and-mask ventilation of the newborn, Apgar score, and neonatal death before discharge (secondary outcomes) among women with and without oxytocin-augmented labor.
RESULTS
The total cohort consisted of 78 931 women, of whom 28 915 (37%) had labor augmented with oxytocin and 50 016 (63%) did not have labor augmented with oxytocin. Women with augmentation of labor had no increased risk of intrapartum stillbirth and first-day mortality (aRR 1.24, 95% CI 0.65-2.4), but decreased risks of suboptimal partograph use (aRR 0.71, 95% CI 0.68-0.74), suboptimal fetal heart rate monitoring (aRR 0.50, 95% CI 0.48-0.53), and emergency cesarean section (aRR 0.62, 95% CI 0.59-0.66), and increased risks of bag-and-mask ventilation (aRR 2.1, 95% CI 1.8-2.5), Apgar score <7 at 5 minutes (aRR 1.65, 95% CI 1.49-1.86), and neonatal death (aRR 1.93, 95% CI 1.46-2.56).
CONCLUSIONS
Although augmentation of labor with oxytocin might be associated with beneficial effects, such as improved monitoring and a decreased risk of cesarean section, its use may lead to an increased risk of adverse perinatal outcomes. We urge for a cautious use of oxytocin to augment labor in low-resource contexts, and call for evidence-based guidelines on augmentation of labor in low-resource settings.
Topics: Adult; Female; Hospitals, Public; Humans; Infant, Newborn; Labor, Obstetric; Nepal; Oxytocics; Oxytocin; Pregnancy; Pregnancy Outcome
PubMed: 32426852
DOI: 10.1111/aogs.13919 -
Pharmaceutical Research Aug 2016To probe the suitability of a dry-powder oxytocin formulation containing a carrier (μco™; SNBL, Ltd.) for intranasal (IN) administration to treat post-partum...
PURPOSE
To probe the suitability of a dry-powder oxytocin formulation containing a carrier (μco™; SNBL, Ltd.) for intranasal (IN) administration to treat post-partum hemorrhage in the developing world. Specifically, to investigate (1) whether IN administration can achieve rapid systemic absorption in cynomolgus monkeys, and (2) whether the formulation exhibits sufficient physical and chemical stability. This study was conducted to support Merck for Mothers, Merck's 10-year global initiative to end preventable maternal deaths.
METHODS
A partial-crossover pharmacokinetic (PK) study in cynomolgus monkeys (n = 6) was utilized to compare in vivo absorption of dry-powder IN oxytocin at three dose levels against an IM injection of an aqueous oxytocin formulation. Particle size distribution, delivered dose and chemical assay were monitored over a 12 month stability study.
RESULTS
IN administration of oxytocin resulted in short (5 min) Tmax and good dose linearity in AUC and Cmax over the dose range tested (10-80 IU per animal). The relative bioavailability (BA) of IN oxytocin to IM injection was approximately 12%. The 80 IU formulation exhibited good physical stability and consistent dosing. After 12 months at 30°C/65%RH, pouched samples retained 86.0% of their original assay value.
CONCLUSIONS
The PK and stability data suggests that IN administration of oxytocin formulated in the μco™ carrier may represent a viable option for rapid systemic absorption in humans and a product compatible with resource-scarce regions.
Topics: Administration, Intranasal; Animals; Cross-Over Studies; Drug Delivery Systems; Macaca fascicularis; Male; Nasal Absorption; Oxytocics; Oxytocin; Time Factors
PubMed: 27194003
DOI: 10.1007/s11095-016-1929-x -
American Journal of Obstetrics &... May 2019The aim of the present systematic review was to investigate the efficacy and safety of cervical ripening for the combination of mechanical dilation and misoprostol... (Meta-Analysis)
Meta-Analysis Review
Maternal and neonatal outcomes with mechanical cervical dilation plus misoprostol compared to misoprostol alone for cervical ripening; a systematic review of literature and metaanalysis.
OBJECTIVE DATA
The aim of the present systematic review was to investigate the efficacy and safety of cervical ripening for the combination of mechanical dilation and misoprostol administration compared with misoprostol alone by evaluating 2 primary outcomes: time to delivery and rate of cesarean delivery.
STUDY
The Medline, EMBASE, and Web-of-Science electronic databases (from conception to end-of-search date December 31, 2018) were searched systematically. Randomized controlled trials that included patients with a singleton viable fetus who underwent induction of labor that required cervical ripening with an unfavorable cervix (Bishop ≤7) were eligible for inclusion.
STUDY APPRAISAL AND SYNTHESIS METHODS
Data were pooled with the use of the random effects and fixed effects model after the assessment for the presence of heterogeneity. Risk of bias for each included study was assessed based on the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS
Eleven trials met the inclusion criteria and included a total of 922 and 947 subjects in the combination and misoprostol-only groups, respectively. There was no difference in the incidence of cesarean delivery between the 2 groups (relative risk, 0.95; 95% confidence interval, 0.80-1.13). The combination of mechanical dilation and misoprostol resulted in overall shorter time to delivery (mean difference, -3.65 hours; 95% confidence interval, 5.23 to -2.07), shorter time to vaginal delivery (mean difference, -4.53 hours; 95% confidence interval, -5.79 to -3.27), lower risk of neonatal intensive care unit admission (relative risk, 0.71; 95% confidence interval, 0.53-0.96), meconium-stained fluid (relative risk, 0.62; 95% confidence interval, 0.43-0.90), tachysystole with fetal heart trace changes (relative risk, 0.53; 95% confidence interval, 0.30-0.94), and terbutaline use (relative risk, 0.63; 95% confidence interval, 0.47-0.85) compared with the use of misoprostol alone. Risk of endometritis (relative risk, 1.07; 95% confidence interval, 0.43-2.61) and chorioamnionitis (relative risk, 1.58; 95% confidence interval, 0.88-2.84) was comparable between the 2 groups.
CONCLUSION
The combination of mechanical cervical dilation with misoprostol for cervical ripening is associated with a shorter time to delivery, a similar rate of cesarean delivery, and a lower incidence of neonatal intensive care unit admission compared with the use of misoprostol alone.
Topics: Administration, Intravaginal; Adult; Cervical Ripening; Dilatation; Female; Humans; Infant, Newborn; Labor, Induced; Misoprostol; Outcome and Process Assessment, Health Care; Oxytocics; Pregnancy
PubMed: 33345815
DOI: 10.1016/j.ajogmf.2019.06.003 -
The Australian & New Zealand Journal of... Feb 2023Secondary postpartum haemorrhage (PPH) complicates ~1% of pregnancies and can cause serious maternal morbidity. However, evidence guiding optimal management is scarce...
BACKGROUND
Secondary postpartum haemorrhage (PPH) complicates ~1% of pregnancies and can cause serious maternal morbidity. However, evidence guiding optimal management is scarce and often based on case series and expert opinion.
AIMS
To measure the success of primary medical therapy in managing secondary PPH and to identify factors associated with need for surgical management.
MATERIALS AND METHODS
Postpartum patients presenting to a tertiary women's hospital emergency department between July 2020 and October 2021 with secondary PPH were recruited. Data from the acute presentation were prospectively collected. Antenatal and intrapartum data were collected from medical record review. The primary outcome was the success of medical management for secondary PPH, defined by the implementation of medical or expectant measures without subsequent need for surgical intervention.
RESULTS
One-hundred and twenty patients underwent primary medical management for secondary PPH. Ninety-eight (82%) were managed successfully with medical management and 22 (18%) required surgery. Medical management involved misoprostol (n = 33; 27.5%), antibiotics (n = 108; 90%), and less commonly other uterotonics (n = 6; 5%). Factors associated with lower rates of successful medical management included: antecedent manual removal of placenta (MROP) (odds ratio (OR) 0.2, P = 0.047), primary PPH ≥500 mL (OR 0.39, P = 0.048) or ≥1 L (OR 0.24, P = 0.009), >200 mL blood loss at presentation (OR 0.17, P = 0.015), increasing time post-delivery (OR 0.84, P = 0.044), retained products of conception (RPOC) on ultrasound (OR 0.024, P = 0.001) and vaginal birth (OR 0.27, P = 0.027).
CONCLUSION
Medical management was highly successful. Vaginal birth, MROP, primary PPH, RPOC on ultrasound and increasing time post-delivery were associated with increased need for surgical management.
Topics: Female; Humans; Pregnancy; Postpartum Hemorrhage; Prospective Studies; Misoprostol; Parturition; Postpartum Period; Oxytocics
PubMed: 35699126
DOI: 10.1111/ajo.13552 -
Emotion (Washington, D.C.) Oct 2018Receiving help can be a "mixed blessing." Despite the many psychosocial benefits it can carry, it sometimes has negative psychological consequences, such as loss in...
Receiving help can be a "mixed blessing." Despite the many psychosocial benefits it can carry, it sometimes has negative psychological consequences, such as loss in self-esteem or enhanced guilt. It is, therefore, important to understand the factors that modify responses to receiving help from others. We explored the role of the hormone oxytocin (OT) on affective and social responses to receiving help, given the putative role of OT in social bonding and attunement. To this end, we manipulated whether help was received from a same-sex interaction partner (confederate) versus a control condition, crossed with a double-blind administration of intranasal OT (vs. placebo), and examined subjective and observer-rated participant responses to help. We observed significant interactions between OT and the help manipulation. In the placebo condition, receiving help from the interaction partner compared with the control condition had negative consequences, such that participants reported greater negative affect and came to view themselves and their interaction partners more negatively after interacting together on several tasks. What is important, however, is that OT administration buffered against these negative subjective responses to receiving help. Further, outside observers rated participants who received OT administration as expressing greater happiness and gratitude in response to help, relative to those who received placebo. In sum, in the context of receiving help from a stranger, oxytocin administration fostered more positive affective and social responses. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
Topics: Adolescent; Adult; Female; Help-Seeking Behavior; Humans; Male; Oxytocics; Oxytocin; Young Adult
PubMed: 29172621
DOI: 10.1037/emo0000369 -
Gynecologie, Obstetrique & Fertilite Jun 2015
Topics: Female; Humans; Informed Consent; Misoprostol; Off-Label Use; Oxytocics; Pregnancy
PubMed: 26004025
DOI: 10.1016/j.gyobfe.2015.04.011 -
BMC Pregnancy and Childbirth Nov 2019Community distribution of misoprostol to pregnant women in advance of labor is one of the compelling strategies for preventing postpartum hemorrhage. Concerns have been... (Review)
Review
INTRODUCTION
Community distribution of misoprostol to pregnant women in advance of labor is one of the compelling strategies for preventing postpartum hemorrhage. Concerns have been reported that misoprostol distribution could reduce facility delivery or lead to misuse of the medication. This scoping review was conducted to synthesize the evidence on the effect of community-based misoprostol distribution on rates of facility delivery, and to assess the frequency of mothers taking distributed misoprostol before delivery, and any harmful outcomes of such misuse.
METHODS
We included peer-reviewed articles on misoprostol implementation from PubMed, Cochrane Review Library, Popline, and Google Scholars. Narrative synthesis was used to analyze and interpret the findings, in which quantitative and qualitative syntheses are integrated.
RESULTS
Three qualitative studies, seven observational studies, and four experimental or quasi-experimental studies were included in this study. All before-after household surveys reported increased delivery coverage after the intervention: ranging from 4 to 46 percentage points at the end of the intervention when compared to the baseline. The pooled analysis of experimental and quasi-experimental studies involving 7564 women from four studies revealed that there was no significant difference in rates of facility delivery among the misoprostol and control groups [OR 1.011; 95% CI: 0.906-1.129]. A qualitative study among health professionals also indicated that community distribution of misoprostol for the prevention of postpartum hemorrhage is acceptable to community members and stakeholders and it is a feasible interim solution until access to facility birth increases. In the community-based distribution of misoprostol programs, self-administration of misoprostol by pregnant women before delivery was reported in less than 2% of women, among seven studies involving 11,108 mothers. Evidence also shows that most women who used misoprostol pills, used them as instructed. No adverse outcomes from misuse in either of the studies reviewed.
CONCLUSIONS
The claim that community-based distribution of misoprostol would divert women who would have otherwise had institutional deliveries to have home deliveries and promote misuse of the medication are not supported with evidence. Therefore, community-based distribution of misoprostol can be an appropriate strategy for reducing maternal deaths which occur due to postpartum hemorrhages, especially in resource-limited settings.
Topics: Delivery of Health Care; Female; Global Health; Humans; Incidence; Labor, Obstetric; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Risk Factors; Survival Rate
PubMed: 31694580
DOI: 10.1186/s12884-019-2539-5