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American Journal of Obstetrics &... Dec 2023Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery. Limited data exist on the safest method of induction to use in this specific patient population.
OBJECTIVE
This study aimed to compare the combination of oxytocin plus a Cook balloon vs misoprostol plus a Cook balloon for induction of labor in high-risk pregnancies.
STUDY DESIGN
We conducted an open-label, randomized controlled trial at a single institution from July 2020 to May 2022. The study was approved by the institutional review board and registered with ClinicalTrials.gov (NCT04492072). Individuals with a high-risk pregnancy, at least ≥22 weeks' gestation, with a singleton in cephalic presentation, Bishop score ≤6, and intact membranes were offered enrollment. A high-risk pregnancy was defined as a pregnancy with any of the following complications: hypertensive disease of pregnancy, fetal growth restriction, oligohydramnios, suspected placental abruption requiring delivery, uncontrolled pregestational diabetes, or abnormal biophysical profile or nonstress test requiring delivery. The primary outcome was the rate of cesarean delivery. Secondary maternal outcomes included induction to delivery interval, number of vaginal deliveries within 24 hours, rates of uterine tachysystole, intraamniotic infection, operative vaginal delivery, and postpartum hemorrhage. Secondary fetal outcomes included fetal heart rate abnormalities, stillbirth, Apgar scores <7 at 5 minutes, admission to the neonatal intensive care unit, arterial umbilical blood pH <7.1, sepsis, and neonatal death. A subgroup analysis was planned for the primary outcome to assess the different indications for cesarean delivery. An intent-to-treat analysis was performed.
RESULTS
During the 22 months of the trial, a total of 150 patients were randomized, and 73 (49%) of those were induced with oxytocin and a Cook balloon and 77 (51%) were induced with misoprostol and a Cook balloon. There was no significant difference in the overall rate of cesarean delivery between the study groups, (21.9% vs 31.1%; relative risk, 0.70; 95% confidence interval, 0.41-1.21), nor among those for which the cesarean delivery was performed for a specific indication. There were no differences in the secondary maternal and fetal or neonatal adverse outcomes.
CONCLUSION
In high-risk pregnancies, the rate of cesarean delivery and adverse maternal and fetal outcomes were similar for induction of labor with oxytocin and a Cook balloon and for induction with misoprostol and a Cook balloon.
Topics: Infant, Newborn; Pregnancy; Humans; Female; Misoprostol; Oxytocin; Oxytocics; Pregnancy, High-Risk; Labor, Induced; Placenta; Cervical Ripening
PubMed: 37806650
DOI: 10.1016/j.ajogmf.2023.101175 -
Obstetrics and Gynecology Jun 2021To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.
DATA SOURCES
Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).
METHODS OF STUDY SELECTION
Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.
TABULATION, INTEGRATION, AND RESULTS
Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.
CONCLUSION
In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020167406.
Topics: Ambulatory Care; Catheters; Cervical Ripening; Cesarean Section; Dilatation; Dinoprostone; Female; Hospitalization; Humans; Labor, Induced; Obstetric Labor Complications; Oxytocics; Pregnancy
PubMed: 33752219
DOI: 10.1097/AOG.0000000000004382 -
Cells Nov 2022At the end of gestation, the cervical tissue changes profoundly. As a result of these changes, the uterine cervix becomes soft and vulnerable to dilation. The process... (Review)
Review
At the end of gestation, the cervical tissue changes profoundly. As a result of these changes, the uterine cervix becomes soft and vulnerable to dilation. The process occurring in the cervical tissue can be described as cervical ripening. The ripening is a process derivative of enzymatic breakdown and inflammatory response. Therefore, it is apparent that cervical remodeling is a derivative of the reactions mediated by multiple factors such as hormones, prostaglandins, nitric oxide, and inflammatory cytokines. However, despite the research carried out over the years, the cellular pathways responsible for regulating this process are still poorly understood. A comprehensive understanding of the entire process of cervical ripening seems crucial in the context of labor induction. Greater knowledge could provide us with the means to help women who suffer from dysfunctional labor. The overall objective of this review is to present the current understanding of cervical ripening in terms of molecular regulation and cell signaling.
Topics: Pregnancy; Infant, Newborn; Humans; Female; Cervical Ripening; Oxytocics; Labor, Induced; Cervix Uteri; Signal Transduction
PubMed: 36429118
DOI: 10.3390/cells11223690 -
Archives of Women's Mental Health Jun 2020Birth experiences can be traumatic and may give rise to PTSD following childbirth (PTSD-FC). Peripartum neurobiological alterations in the oxytocinergic system are... (Review)
Review
Birth experiences can be traumatic and may give rise to PTSD following childbirth (PTSD-FC). Peripartum neurobiological alterations in the oxytocinergic system are highly relevant for postpartum maternal behavioral and affective adaptions like bonding and lactation but are also implicated in the response to traumatic events. Animal models demonstrated that peripartum stress impairs beneficial maternal postpartum behavior. Early postpartum activation of the oxytocinergic system may, however, reverse these effects and thereby prevent adverse long-term consequences for both mother and infant. In this narrative review, we discuss the impact of trauma and PTSD-FC on normal endogenous oxytocinergic system fluctuations in the peripartum period. We also specifically focus on the potential of exogenous oxytocin (OT) to prevent and treat PTSD-FC. No trials of exogenous OT after traumatic childbirth and PTSD-FC were available. Evidence from non-obstetric PTSD samples and from postpartum healthy or depressed samples implies restorative functional neuroanatomic and psychological effects of exogenous OT such as improved PTSD symptoms and better mother-to-infant bonding, decreased limbic activation, and restored responsiveness in dopaminergic reward regions. Adverse effects of intranasal OT on mood and the increased fear processing and reduced top-down control over amygdala activation in women with acute trauma exposure or postpartum depression, however, warrant cautionary use of intranasal OT. Observational and experimental studies into the role of the endogenous and exogenous oxytocinergic system in PTSD-FC are needed and should explore individual and situational circumstances, including level of acute distress, intrapartum exogenous OT exposure, or history of childhood trauma.
Topics: Animals; Delivery, Obstetric; Depression, Postpartum; Female; Humans; Maternal Behavior; Mice; Oxytocics; Oxytocin; Parturition; Peripartum Period; Postpartum Period; Pregnancy; Rats; Stress Disorders, Post-Traumatic
PubMed: 31385103
DOI: 10.1007/s00737-019-00994-0 -
Gynecologic and Obstetric Investigation 2023Our study's primary objective was to examine the effects of four different prophylactic protocols on the prevention of postpartum hemorrhage following vaginal birth,... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Our study's primary objective was to examine the effects of four different prophylactic protocols on the prevention of postpartum hemorrhage following vaginal birth, including carbetocin only, oxytocin only, and a combination of carbetocin or oxytocin with tranexamic acid.
DESIGN
A multicentric randomized controlled trial.
PARTICIPANTS/MATERIALS, SETTING, AND METHODS
This multicentric center prospective randomized controlled trial was conducted at the Department of Obstetrics and Gynecology of Bezmialem University and Van Health Teaching and Research Hospital from August 2022 to January 2023. The collected data included age, gravidity, parity, gestational age at birth, duration of delivery stages, prepartum hemoglobin and hematocrit concentrations, changes in hemoglobin and hematocrit concentrations, intrapartum blood loss, estimated blood loss after 2 h of vaginal delivery, Apgar scores at 1 and 5 min, birth weight, and neonatal intensive care unit (NICU) admission. Intrapartum blood loss was objectively measured in milliliters using a postpartum drape with a calibrated bag. The amount of bleeding was measured by subtracting the empty weight of the pads placed under the patient in the patient's bed within 2 h after delivery. Group I: carbetocin 100 μg/mL (n = 75), group II: oxytocin 5 IU/mL (n = 75), group III: carbetocin and tranexamic acid 50 mg/mL (n = 75), group IV: oxytocin and tranexamic acid (n = 75).
RESULTS
The hemoglobin concentration decrease significantly differed between groups (1.03 ± 1.04, 1.3 ± 0.85, 1.4 ± 0.85, 1.41 ± 0.87, respectively; p < 0.001). Group 4 has the highest decrease in hemoglobin and hematocrit concentrations. When we investigated the subgroup differences, the decrease in hemoglobin concentration was significantly higher in group 2 than group 1 (1.30 ± 0.85 vs. 1.03 ± 1.04; p = 0.023), in group 2 than group 3 (1.3 ± 0.85 vs. 1.04 ± 0.9; p = 0.013), and in group 4 than group 3 (1.41 ± 0.87 vs. 1.04 ± 0.9; p < 0.001). The decrease in hematocrit level was significantly different between groups (3.07 ± 3.23, 3.55 ± 2.44, 2.13 ± 3.09, 4.25 ± 2.52; p < 0.001, respectively). No significant differences were observed in terms of mean blood loss between the four groups (277.19 ± 208.10, 294.13 ± 198.64, 274.33 ± 199.57, and 283.97 ± 178.11; p = 0.445, respectively). Furthermore, there was no significant difference between the groups in the rate of need for blood transfusion (1.3%, 5.4%, 4%, and 4%, respectively; p = 0.6).
LIMITATIONS
The most important limitation of the study is a relatively small number of participants.
CONCLUSION
In conclusion, our findings suggest that carbetocin may be more successful than oxytocin and oxytocin plus tranexamic acid regimens in terms of postpartum hemoglobin reduction, and there is no difference in terms of the need for blood transfusion when it is used for postpartum hemorrhage prophylaxis after vaginal delivery.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Oxytocin; Postpartum Hemorrhage; Tranexamic Acid; Oxytocics; Prospective Studies; Delivery, Obstetric; Hemoglobins
PubMed: 37778349
DOI: 10.1159/000534375 -
Journal of Obstetrics and Gynaecology... May 2022Despite advances in health care and ample resources, post-partum hemorrhage (PPH) rates are increasing in high income countries. Although guidelines recommend... (Review)
Review
OBJECTIVE
Despite advances in health care and ample resources, post-partum hemorrhage (PPH) rates are increasing in high income countries. Although guidelines recommend therapeutic uterotonics, timing of administration is open to judgement and most often based on (inherently inaccurate) visual estimates of blood loss. With severe hemorrhage, every minute of delay can have significant consequences. Our objective was to examine the timing of uterotonic administration and its impact upon maternal outcomes. We hypothesized that increased time to uterotonic administration following the identification of PPH would be associated with a greater decline in hemoglobin (Hb) and higher odds of hypotension and transfusion.
METHODS
We reviewed all cases of PPH that occurred at an academic centre between June 2015 and September 2017. All cases of primary PPH (i.e., those declared within 24 h of delivery with estimated blood loss [EBL] >500 mL for vaginal and >1000 mL for cesarean deliveries) were analyzed. Patient records were excluded if they were missing information regarding time of PPH declaration, uterotonic administration, and/or Hb measures, or if a pre-existing medical condition could have contributed to PPH.
RESULTS
Of 4397 births, there were 259 (5.9%) cases of primary PPH, of which 128 were included in this analysis. For these patients, each 5-minute delay in uterotonic treatment was associated with 26% higher odds of hypotension following delivery of any type. For vaginal deliveries (n = 86), each 5-minute delay was associated with 31% and 34% higher odds of hypotension and transfusion, respectively.
CONCLUSION
In this study, delay in administration of therapeutic uterotonics was associated with a higher incidence of hypotension and transfusion in primary PPH patients.
Topics: Ergonovine; Female; Humans; Hypotension; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies
PubMed: 34844004
DOI: 10.1016/j.jogc.2021.11.011 -
Cerebral Cortex (New York, N.Y. : 1991) Feb 2021Attention and salience processing have been linked to the intrinsic between- and within-network dynamics of large-scale networks engaged in internal (default network... (Randomized Controlled Trial)
Randomized Controlled Trial
Attention and salience processing have been linked to the intrinsic between- and within-network dynamics of large-scale networks engaged in internal (default network [DN]) and external attention allocation (dorsal attention network [DAN] and salience network [SN]). The central oxytocin (OXT) system appears ideally organized to modulate widely distributed neural systems and to regulate the switch between internal attention and salient stimuli in the environment. The current randomized placebo (PLC)-controlled between-subject pharmacological resting-state fMRI study in N = 187 (OXT, n = 94; PLC, n = 93; single-dose intranasal administration) healthy male and female participants employed an independent component analysis approach to determine the modulatory effects of OXT on the within- and between-network dynamics of the DAN-SN-DN triple network system. OXT increased the functional integration between subsystems within SN and DN and increased functional segregation of the DN with both attentional control networks (SN and DAN). Whereas no sex differences were observed, OXT effects on the DN-SN interaction were modulated by autistic traits. Together, the findings suggest that OXT may facilitate efficient attention allocation by modulating the intrinsic functional dynamics between DN components and large-scale networks involved in external attentional demands (SN and DAN).
Topics: Administration, Intranasal; Adult; Attention; Brain; Female; Humans; Magnetic Resonance Imaging; Male; Neural Pathways; Oxytocics; Oxytocin
PubMed: 30535355
DOI: 10.1093/cercor/bhy295 -
International Journal of Molecular... Nov 2021Oxytocin (OT) and vasopressin (AVP) are hypothalamic neuropeptides classically associated with their regulatory role in reproduction, water homeostasis, and social... (Review)
Review
Oxytocin (OT) and vasopressin (AVP) are hypothalamic neuropeptides classically associated with their regulatory role in reproduction, water homeostasis, and social behaviors. Interestingly, this role has expanded in recent years and has positioned these neuropeptides as therapeutic targets for various neuropsychiatric diseases such as autism, addiction, schizophrenia, depression, and anxiety disorders. Due to the chemical-physical characteristics of these neuropeptides including short half-life, poor blood-brain barrier penetration, promiscuity for AVP and OT receptors (AVP-R, OT-R), novel ligands have been developed in recent decades. This review summarizes the role of OT and AVP in neuropsychiatric conditions, as well as the findings of different OT-R and AVP-R agonists and antagonists, used both at the preclinical and clinical level. Furthermore, we discuss their possible therapeutic potential for central nervous system (CNS) disorders.
Topics: Animals; Central Nervous System Diseases; Drug Agonism; Drug Antagonism; Humans; Mental Disorders; Oxytocics; Oxytocin; Vasoconstrictor Agents; Vasopressins
PubMed: 34769501
DOI: 10.3390/ijms222112077 -
BJOG : An International Journal of... Apr 2020
Topics: Female; Humans; Labor Stage, Third; Oxytocics; Parturition; Postpartum Hemorrhage; Pregnancy
PubMed: 31876346
DOI: 10.1111/1471-0528.16077 -
Journal of Mother and Child Dec 2020Prolonged labour can lead to postpartum complications and adverse outcomes for both mother and baby. Measurable parameters can help in the active management of labour,... (Review)
Review
Prolonged labour can lead to postpartum complications and adverse outcomes for both mother and baby. Measurable parameters can help in the active management of labour, timely diagnosis of dystocia and in the choice of the method of delivery. Progressive uterine contractions are necessary to complete labour successfully. Myometrial fatigue during prolonged labour causes a change from aerobic to anaerobic metabolism, resulting in an accumulation of intramuscular lactic acid and probably a subsequent increase in amniotic fluid lactate concentration. High amniotic fluid lactate level has been associated with ineffective uterine contractions leading to labour arrest. A considerable number of studies conducted so far indicate that the level of lactate in amniotic fluid may be a new non-invasive diagnostic tool for early prediction of prolonged labour and the need for immediate obstetric intervention. Low amniotic fluid lactate level may facilitate a decision to continue vaginal labour by oxytocin augmentation. A high level of amniotic fluid lactate is associated with surgical obstetric procedures. Measuring amniotic fluid lactate level might simplify the patient's allocation to a group, which will benefit from the administration of oxytocin and to a group that will not benefit from further prolongation of labour. This study aimed to briefly review current knowledge on amniotic fluid lactate concentrations measured using standard biochemical methods during the first stage of labour following normal pregnancy, as a possible diagnostic tool for prolonged labour. For this purpose, PubMed, EMBASE, Medline (1990 to July 2020) trials register and reference lists of relevant articles were searched.
Topics: Amniotic Fluid; Female; Humans; Lactic Acid; Obstetric Labor Complications; Oxytocics; Pregnancy; Pregnancy Outcome; Time Factors
PubMed: 33470958
DOI: 10.34763/jmotherandchild.20202403.2027.d-20-00011