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The Cochrane Database of Systematic... Nov 2015Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage. The majority of miscarriages occur in the first trimester. The aim of cervical ripening is to reduce the possibility of injury to the uterus and cervix and improve the surgical ease of the procedure. Cervical ripening agents can have adverse effects and it is uncertain as to whether these risks outweigh the benefits of their use.
OBJECTIVES
To systematically review the benefits and harms of using cervical ripening agents prior to surgical evacuation of non-viable pregnancy prior to 14 weeks' gestation.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015) and reference lists of retrieved papers.
SELECTION CRITERIA
Randomised controlled trials (published in full-text form, or as abstracts only), which assessed the use of pharmacological or mechanical agents to ripen the cervix in women undergoing dilation and curettage or vacuum aspiration for non-viable pregnancy at less than 14 weeks' gestation were eligible for inclusion. Cluster-randomised controlled trials and trials using a cross-over design were not eligible for inclusion.Unpublished randomised controlled trials and quasi-randomised trials would have been eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data were checked for accuracy.
MAIN RESULTS
We included nine trials with 469 women. A diverse set of medications and regimens were studied in these trials, making the comparisons available for meta-analysis limited. The comparisons draw data from six trials with 383 participants. All trials were relatively small and had several aspects of unclear risk of bias with few of this review's outcomes reported. Due to this, no data from three trials were able to be used despite them meeting inclusion criteria.We carried out four comparisons: isosorbide mononitrate or dinitrate compared with misoprostol; misoprostol compared with placebo; chemical dilation (use of medications) compared with mechanical dilation; and any cervical preparation compared with placebo.None of the included studies reported data on the review's primary outcome: cervical or uterine injury (perforation, laceration, creation of a false passage).No clear difference was shown between isosorbide compounds and misoprostol for the outcome need for manual cervical dilation (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.10 to 5.64; three trials, 150 women; Tau² = 2.11; I² = 69%), however the data were heterogenous. In terms of adverse effects, misoprostol was associated with more vomiting (RR 0.11, 95% CI 0.01 to 0.85; two trials, 120 women), however there were no clear differences between isosorbide compounds and misoprostol in relation to other reported adverse effects (headache, nausea or hypotension). The dosing regimens differed in terms of dose, number of administrations and route of administration in the different trials. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators in a single trial (65 women) that measured difficulty in cervical dilation, excessive bleeding and adverse effects.Misoprostol was shown to be more effective than placebo for cervical ripening (reduced need for manual cervical dilation) (RR 0.14, 95% CI 0.08 to 0.26; one trial, 120 women), and surgical time was reduced when misoprostol was used (mean difference (MD) -3.15, 95% CI -3.59 to -2.70; one trial, 120 women). However, compared to placebo, misoprostol, was associated with more abdominal pain (RR 29.00, 95% CI 1.77 to 475.35; one trial, 120 women), although no clear differences in the risk of other adverse effects (nausea, vomiting, headache or fever) were observed between groups.There was no clear differences between chemical dilation and mechanical dilators for the outcomes: difficulty in cervical dilation, excessive bleeding or adverse effects.Compared with placebo, any cervical preparation reduced the need for manual cervical dilatation (average RR 0.25, 95% CI 0.07 to 0.89; two trials, 168 women; Tau² = 0.67; I² = 81%), and reduced surgical time (MD -2.55, 95% CI -3.67 to -1.43, two trials, 168 women; Tau² = 0.63; I² = 96%).None of the included trials reported on the review's other secondary outcomes, including: injury to bladder or bowel, miscarriage/preterm birth in a subsequent pregnancy, analgesia use after administration of ripening agent but before surgery, or analgesia use after surgery.
AUTHORS' CONCLUSIONS
This review found no evidence to evaluate cervical ripening prior to first trimester surgical evacuation for miscarriage for reducing the rate of cervical or uterine injury, however, this may be because these outcomes are very rare. Cervical preparation was shown to reduce the need for manual cervical dilatation compared with placebo.Misoprostol and isosorbide mononitrate and dinitrate were similarly effective in ripening the cervix, however there was more vomiting with misoprostol. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators.The nine studies included in this review were small and the methodological quality of the trials was mixed, and for the most part, not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Consequently, large, high-quality trials are required to determine whether the benefits of this treatment outweigh the risks. Further research should be powered to assess the rate of cervical and uterine injury between interventions. Future research should also guide clinicians in deciding whether the benefits of reduced manual cervical dilatation outweigh the risks of adverse effects associated with these agents (nausea, vomiting, headache, fever, diarrhoea and pain). Women's satisfaction and outcomes of future pregnancies should also be assessed.
Topics: Abortion, Eugenic; Abortion, Spontaneous; Adult; Cervical Ripening; Dilatation; Female; Humans; Isosorbide Dinitrate; Labor Stage, First; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic
PubMed: 26559875
DOI: 10.1002/14651858.CD009954.pub2 -
The Cochrane Database of Systematic... Jun 2017Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is... (Review)
Review
BACKGROUND
Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.
OBJECTIVES
To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.
MAIN RESULTS
Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.
AUTHORS' CONCLUSIONS
RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.
Topics: Dinoprostone; Early Termination of Clinical Trials; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Uterine Rupture; Vaginal Birth after Cesarean
PubMed: 28599068
DOI: 10.1002/14651858.CD009792.pub3 -
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 -
PloS One 2018An urgent need exists to improve and maintain intrapartum skills of providers in sub-Saharan Africa. Peer-assisted learning may address this need, but few rigorous...
Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda.
An urgent need exists to improve and maintain intrapartum skills of providers in sub-Saharan Africa. Peer-assisted learning may address this need, but few rigorous evaluations have been conducted in real-world settings. A pragmatic, cluster-randomized trial in 12 Ugandan districts provided facility-based, team training for prevention and management of postpartum hemorrhage and birth asphyxia at 125 facilities. Three approaches to facilitating simulation-based, peer assisted learning were compared. The primary outcome was the proportion of births with uterotonic given within one minute of birth. Outcomes were evaluated using observation of birth and supplemented by skills assessments and service delivery data. Individual and composite variables were compared across groups, using generalized linear models. Overall, 107, 195, and 199 providers were observed at three time points during 1,716 births across 44 facilities. Uterotonic coverage within one minute increased from: full group: 8% (CI 4%‒12%) to 50% (CI 42%‒59%); partial group: 19% (CI 9%‒30%) to 42% (CI 31%‒53%); and control group: 11% (5%‒7%) to 51% (40%‒61%). Observed care of mother and newborn improved in all groups. Simulated skills maintenance for postpartum hemorrhage prophylaxis remained high across groups 7 to 8 months after the intervention. Simulated skills for newborn bag-and-mask ventilation remained high only in the full group. For all groups combined, incidence of postpartum hemorrhage and retained placenta declined 17% and 47%, respectively, from during the intervention period compared to the 6‒9 month period after the intervention. Fresh stillbirths and newborn deaths before discharge decreased by 34% and 62%, respectively, from baseline to after completion, and remained reduced 6‒9 months post-implementation. Significant improvements in uterotonic coverage remained across groups 6 months after the intervention. Findings suggest that while short, simulation-based training at the facility improves care and is feasible, more complex clinical skills used infrequently such as newborn resuscitation may require more practice to maintain skills. Trial Registration: ClinicalTrials.gov NCT03254628.
Topics: Asphyxia Neonatorum; Female; Humans; Infant, Newborn; Male; Outcome Assessment, Health Care; Oxytocics; Patient Care Team; Peer Group; Perinatal Care; Postpartum Hemorrhage; Pregnancy; Problem-Based Learning; Simulation Training; Teaching; Uganda
PubMed: 30557350
DOI: 10.1371/journal.pone.0207909 -
Reproductive Sciences (Thousand Oaks,... Dec 2023This study compares the effectiveness and safety of oxytocin infusion against oral misoprostol for inducing labour in pregnant women with term prelabor membrane rupture.... (Randomized Controlled Trial)
Randomized Controlled Trial
This study compares the effectiveness and safety of oxytocin infusion against oral misoprostol for inducing labour in pregnant women with term prelabor membrane rupture. We randomized 173 pregnant women presenting with term prelabor rupture of membranes (PROM) at Ain Shams University Maternity Hospital into Group A (underwent induction of labor (IOL) by 25μg misoprostol oral tablet every 4 h, for maximum 5 doses) and an identical Group B: (underwent IOL by oxytocin infusion according to the hospital protocol). Our primary outcome was rate of vaginal delivery within 24 h, while the secondary outcomes included the time till active phase, induction to delivery interval, maternal pyrexia, nausea and vomiting, fetal distress, Apgar score, birth weight, and neonatal intensive care unit admission. Both groups showed high rates of vaginal delivery (82.4% & 87.1% for misoprostol group and oxytocin group respectively) with no significant difference between the two groups (p=0.394). However, patients induced by misoprostol took significantly less time to reach active phase with a shorter induction to delivery interval as compared to patients induced with oxytocin. This difference was clear in multiparous women, but not observed in primiparous women when subgroup analysis was done. No significant difference was found as regards other outcomes. Our study showed that both oral misoprostol and oxytocin are effective and safe for IOL in patients with PROM, with shorter induction-delivery interval in patients induced by oral misoprostol, an effect that is clear in multiparous but not primiparous women. TRIAL REGISTRATION: NCT05215873, on 31/01/2022, "retrospectively registered".
Topics: Infant, Newborn; Female; Pregnancy; Humans; Misoprostol; Oxytocin; Oxytocics; Pregnant Women; Fetal Membranes, Premature Rupture; Labor, Induced
PubMed: 37442883
DOI: 10.1007/s43032-023-01290-0 -
BMC Pregnancy and Childbirth Oct 2015The association between birth position and obstetric anal sphincter injury (OASIS) in spontaneous vaginal deliveries is unclear.
BACKGROUND
The association between birth position and obstetric anal sphincter injury (OASIS) in spontaneous vaginal deliveries is unclear.
METHODS
The study was based on the Stockholm-Gotland Obstetric Database (Sweden) from Jan 1(st) 2008 to Oct 22(nd) 2014 and included 113 279 singleton spontaneous vaginal births with no episiotomy. We studied risk of OASIS with respect to the following birth positions: a) sitting, b) lithotomy, c) lateral, d) standing on knees, e) birth seat, f) supine, g) squatting, h) standing and i) all fours. All analyses were stratified for parity. General linear models were used to calculate risk ratios (RR) adjusted for maternal, pregnancy and fetal characteristics.
RESULTS
The rates of OASIS among nulliparous women, parous women and women undergoing vaginal birth after a caesarean (VBAC) were 5.7%, 1.3% and 10.6%, respectively. The rates varied by birth position: from 3.7 to 7.1% in nulliparous women, 0.6% to 2.6% in parous women and 5.6% to 18.2% in women undergoing VBAC. Regardless of parity, the lowest rates were found among women giving birth in standing position and the highest rates among women birthing in the lithotomy position. Compared with sitting position, the lithotomy position involved an increased risk of OASIS among nulliparous (adjusted RR 1.17, 95% CI 1.06-1.29) and parous women (adjusted RR 1.66, 95% CI 1.35-2.05). Birth seat and squatting position involved an increased risk of OASIS among parous women (adjusted RR [95% CI] 1.36 [1.03-1.80] and 2.16 [1.15-4.07], respectively). Independent risk factors for OASIS were maternal age, head circumference ≥35 cm, birth weight ≥4000 g, length of gestation ≥ 40 weeks, prolonged second stage of labour, non-occiput anterior presentation and oxytocin augmentation.
CONCLUSIONS
Compared with sitting position, lateral position has a slightly protective effect in nulliparous women whilst an increased risk is noted among women in the lithotomy position, irrespective of parity. Squatting and birth seat position involve an increase in risk among parous women.
Topics: Adult; Anal Canal; Birth Weight; Cephalometry; Female; Gestational Age; Humans; Labor Presentation; Lacerations; Maternal Age; Obstetric Labor Complications; Oxytocics; Oxytocin; Parity; Patient Positioning; Pregnancy; Prevalence; Risk Assessment; Risk Factors; Sweden; Vaginal Birth after Cesarean
PubMed: 26453177
DOI: 10.1186/s12884-015-0689-7 -
American Journal of Obstetrics and... Aug 2017Although oxytocin commonly is used to augment or induce labor, it is difficult to predict its effectiveness because oxytocin dose requirements vary significantly among...
BACKGROUND
Although oxytocin commonly is used to augment or induce labor, it is difficult to predict its effectiveness because oxytocin dose requirements vary significantly among women. One possibility is that women requiring high or low doses of oxytocin have variations in the oxytocin receptor gene.
OBJECTIVES
To identify oxytocin receptor gene variants in laboring women with low and high oxytocin dosage requirements.
STUDY DESIGN
Term, nulliparous women requiring oxytocin doses of ≤4 mU/min (low-dose-requiring, n = 83) or ≥20 mU/min (high-dose-requiring, n = 104) for labor augmentation or induction provided consent to a postpartum blood draw as a source of genomic DNA. Targeted-amplicon sequencing (coverage >30×) with MiSeq (Illumina) was performed to discover variants in the coding exons of the oxytocin receptor gene. Baseline relevant clinical history, outcomes, demographics, and oxytocin receptor gene sequence variants and their allele frequencies were compared between low-dose-requiring and high-dose-requiring women. The Scale-Invariant Feature Transform algorithm was used to predict the effect of variants on oxytocin receptor function. The Fisher exact or χ tests were used for categorical variables, and Student t tests or Wilcoxon rank sum tests were used for continuous variables. A P value < .05 was considered statistically significant.
RESULTS
The high-dose-requiring women had greater rates of obesity and diabetes and were more likely to have undergone labor induction and required prostaglandins. High-dose-requiring women were more likely to undergo cesarean delivery for first-stage arrest and less likely to undergo cesarean delivery for nonreassuring fetal status. Targeted sequencing of the oxytocin receptor gene in the total cohort (n = 187) revealed 30 distinct coding variants: 17 nonsynonymous, 11 synonymous, and 2 small structural variants. One novel variant (A243T) was found in both the low- and high-dose-requiring groups. Three novel variants (Y106H, A240_A249del, and P197delfs*206) resulting in an amino acid substitution, loss of 9 amino acids, and a frameshift stop mutation, respectively, were identified only in low-dose-requiring women. Nine nonsynonymous variants were unique to the high-dose-requiring group. These included 3 known variants (R151C, G221S, and W228C) and 6 novel variants (M133V, R150L, H173R, A248V, G253R, and I266V). Of these, R150L, R151C, and H173R were predicted by Scale-Invariant Feature Transform algorithm to damage oxytocin receptor function. There was no statistically significant association between the numbers of synonymous and nonsynonymous substitutions in the patient groups.
CONCLUSION
Obesity, diabetes, and labor induction were associated with the requirement for high doses of oxytocin. We did not identify significant differences in the prevalence of oxytocin receptor variants between low-dose-requiring and high-dose-requiring women, but novel oxytocin receptor variants were enriched in the high-dose-requiring women. We also found 3 oxytocin receptor variants (2 novel, 1 known) that were predicted to damage oxytocin receptor function and would likely increase an individual's risk for requiring a high oxytocin dose. Further investigation of oxytocin receptor variants and their effects on protein function will inform precision medicine in pregnant women.
Topics: Adult; DNA; Female; Genetic Variation; Humans; Labor, Obstetric; Oxytocics; Oxytocin; Pregnancy; Prospective Studies; Receptors, Oxytocin
PubMed: 28456503
DOI: 10.1016/j.ajog.2017.04.036 -
Effect of an oxytocin protocol on secondary uterotonic use in patients undergoing Cesarean delivery.Canadian Journal of Anaesthesia =... Jul 2023Protocol-driven oxytocin regimens can reduce oxytocin administration compared with a nonprotocol free-flow continuous infusion. Our aim was to compare secondary...
PURPOSE
Protocol-driven oxytocin regimens can reduce oxytocin administration compared with a nonprotocol free-flow continuous infusion. Our aim was to compare secondary uterotonic use between a modified "rule of threes" oxytocin protocol and a free-flow continuous oxytocin infusion after Cesarean delivery.
METHODS
We conducted a retrospective before-and-after study to compare patients who underwent Cesarean delivery between 1 January 2010 and 31 December 2013 (preprotocol) with patients who underwent Cesarean delivery between 1 January 2015 and 31 August 2017 (postprotocol). The preprotocol group received free-flow oxytocin administration and the postprotocol group received oxytocin according to a modified rule of threes algorithm. The primary outcome was secondary uterotonic use and the secondary outcomes included blood transfusion, hemoglobin value < 8 g·dL, and estimated blood loss.
RESULTS
In total, 4,010 Cesarean deliveries were performed in 3,637 patients (2,262 preprotocol and 1,748 postprotocol). The odds of receiving secondary uterotonic drugs were increased in the postprotocol group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.04 to 1.70; P = 0.02). Patients in the postprotocol group were less likely to receive a blood transfusion. Nevertheless, the two groups were similar for the composite end point of transfusion or hemoglobin < 8 g·dL (OR, 0.86; 95% CI, 0.66 to 1.11; P = 0.25). The odds of an estimated blood loss greater than 1,000 mL were reduced in the postprotocol group (OR, 0.64; 95% CI, 0.50 to 0.84; P = 0.001).
CONCLUSIONS
Patients in the modified rule of threes oxytocin protocol group were more likely to receive a secondary uterotonic than those in the preprotocol group. Estimated blood loss and transfusion outcomes were similar.
Topics: Pregnancy; Female; Humans; Oxytocin; Oxytocics; Retrospective Studies; Cesarean Section; Blood Transfusion; Postpartum Hemorrhage
PubMed: 37280454
DOI: 10.1007/s12630-023-02496-1 -
The Cochrane Database of Systematic... Mar 2021Retained placenta is a common complication of pregnancy affecting 1% to 6% of all births. If a retained placenta is left untreated, spontaneous delivery of the placenta... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Retained placenta is a common complication of pregnancy affecting 1% to 6% of all births. If a retained placenta is left untreated, spontaneous delivery of the placenta may occur, but there is a high risk of bleeding and infection. Manual removal of the placenta (MROP) in an operating theatre under anaesthetic is the usual treatment, but is invasive and may have complications. An effective non-surgical alternative for retained placenta would potentially reduce the physical and psychological trauma of the procedure, and costs. It could also be lifesaving by providing a therapy for settings without easy access to modern operating theatres or anaesthetics. Injection of uterotonics into the uterus via the umbilical vein and placenta is an attractive low-cost option for this. This is an update of a review last published in 2011.
OBJECTIVES
To assess the use of umbilical vein injection (UVI) of saline solution with or without uterotonics compared to either expectant management or with an alternative solution or other uterotonic agent for retained placenta.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (14 June 2020), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing UVI of saline or other fluids (with or without uterotonics), either with expectant management or with an alternative solution or other uterotonic agent, in the management of retained placenta. We considered quasi-randomised, cluster-randomised, and trials reported only in abstract form.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach. We calculated pooled risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs), and presented results using 'Summary of findings' tables.
MAIN RESULTS
We included 24 trials (n = 2348). All included trials were RCTs, one was quasi-randomised, and none were cluster-randomised. Risk of bias was variable across the included studies. We assessed certainty of evidence for four comparisons: saline versus expectant management, oxytocin versus expectant management, oxytocin versus saline, and oxytocin versus plasma expander. Evidence was moderate to very-low certainty and downgraded for risk of bias of included studies, imprecision, and inconsistency of effect estimates. Saline solution versus expectant management There is probably little or no difference in the incidence of MROP between saline and expectant management (RR 0.93, 95% CI 0.80 to 1.10; 5 studies, n = 445; moderate-certainty evidence). Evidence for the following remaining primary outcomes was very-low certainty: severe postpartum haemorrhage 1000 mL or greater, blood transfusion, and infection. There were no events reported for maternal mortality or postpartum anaemia (24 to 48 hours postnatal). No studies reported addition of therapeutic uterotonics. Oxytocin solution versus expectant management UVI of oxytocin solution might slightly reduce in the need for manual removal compared with expectant management (mean RR 0.73, 95% CI 0.56 to 0.95; 7 studies, n = 546; low-certainty evidence). There may be little to no difference between the incidence of blood transfusion between groups (RR 0.81, 95% CI 0.47 to 1.38; 4 studies, n = 339; low-certainty evidence). There were no maternal deaths reported (2 studies, n = 93). Evidence for severe postpartum haemorrhage of 1000 mL or greater, additional uterotonics, and infection was very-low certainty. There were no events for postpartum anaemia (24 to 48 hours postnatal). Oxytocin solution versus saline solution UVI of oxytocin solution may reduce the use of MROP compared with saline solution, but there was high heterogeneity (RR 0.82, 95% CI 0.69 to 0.97; 14 studies, n = 1370; I² = 54%; low-certainty evidence). There were no differences between subgroups according to risk of bias or oxytocin dose for the outcome MROP. There may be little to no difference between groups in severe postpartum haemorrhage of 1000 mL or greater, blood transfusion, use of additional therapeutic uterotonics, and antibiotic use. There were no events for postpartum anaemia (24 to 48 hours postnatal) (very low-certainty evidence) and there was only one event for maternal mortality (low-certainty evidence). Oxytocin solution versus plasma expander One small study reported UVI of oxytocin compared with plasma expander (n = 109). The evidence was very unclear about any effect on MROP or blood transfusion between the two groups (very low-certainty evidence). No other primary outcomes were reported. For other comparisons there were little to no differences for most outcomes examined. However, there was some evidence to suggest that there may be a reduction in MROP with prostaglandins in comparison to oxytocin (4 studies, n = 173) and ergometrine (1 study, n = 52), although further large-scale studies are needed to confirm these findings.
AUTHORS' CONCLUSIONS
UVI of oxytocin solution is an inexpensive and simple intervention that can be performed when placental delivery is delayed. This review identified low-certainty evidence that oxytocin solution may slightly reduce the need for manual removal. However, there are little or no differences for other outcomes. Small studies examining injection of prostaglandin (such as dissolved misoprostol) into the umbilical vein show promise and deserve to be studied further.
Topics: Anti-Bacterial Agents; Bias; Blood Transfusion; Female; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Placenta, Retained; Plasma Substitutes; Pregnancy; Prostaglandins; Randomized Controlled Trials as Topic; Sodium Chloride; Umbilical Veins
PubMed: 33705565
DOI: 10.1002/14651858.CD001337.pub3 -
Computational and Mathematical Methods... 2022The efficacy of oxytocin and carbetocin in preventing postpartum hemorrhage (PPH) in women with vaginal delivery has been controversial. This study is aimed at... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The efficacy of oxytocin and carbetocin in preventing postpartum hemorrhage (PPH) in women with vaginal delivery has been controversial. This study is aimed at conducting a meta-analysis that compares the efficacy of carbetocin and oxytocin in the prevention of PPH among women with vaginal delivery.
METHODS
Literature was retrieved from PubMed, Medline, Embase, CENTRAL, and CNKI databases. The randomized controlled trials (RCTs) that compare the efficacy of carbetocin and oxytocin to prevent PPH were searched. Data from the included literatures were extracted by two researchers, including author, title, publication date, study type, study number, the incidence of PPH, number of patients requiring additional uterotonics, and number of patients requiring blood transfusion. Jadad scale was used to evaluate the quality of the included RCTs. The Chi-square test was adopted for the heterogeneity test. A fixed-effect model was used for analysis if heterogeneity did not exist between literatures. If heterogeneity exists between literatures, a random-effect model was used for analysis. The source of heterogeneity was explored by subgroup analysis and sensitivity analysis.
RESULTS
The incidence of PPH in the carbetocin group was lower than that in the oxytocin group (OR = 0.62, 95% CI (0.46, 0.84), = 3.14, = 0.002). There was no heterogeneity among studies ( = 7.29, = 0.12, = 45%) and no significant publication bias ( > 0.05). The proportion of women requiring additional uterotonics in the carbetocin group was lower than that in the oxytocin group (OR = 0.41, 95% CI (0.29, 0.56), = 5.34, < 0.00001). There was no heterogeneity among studies ( = 0.82, = 0.84, = 0%) and no significant publication bias ( > 0.05). There was no significant difference in the proportion of women needing blood transfusion between the carbetocin group and the oxytocin group (OR = 0.92, 95% CI (0.66, 1.29), = 0.46, = 0.64). There was no heterogeneity among studies ( = 3.06, = 0.55, = 0%) and no significant publication bias ( > 0.05).
CONCLUSION
Carbetocin is superior to oxytocin in preventing PPH among women with vaginal delivery and can be widely used in clinical practice.
Topics: Delivery, Obstetric; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy
PubMed: 35770122
DOI: 10.1155/2022/6420738