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Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

ABSTRACT: OBJECTIVE:A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor. METHODS:We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation. RESULTS:From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes. CONCLUSION:Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT03342508. FUNDING SOURCE:The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.

SUBMITTER: Lassey SC

PROVIDER: S-EPMC7098440 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

Lassey Sarah C SC Little Sarah E SE Saadeh Michael M Patton Nicole N Farber Michaela K MK Bateman Brian T BT Robinson Julian N JN

Obstetrics and gynecology 20200401 4

<h4>Objective</h4>A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor.<h4>Methods</h4>We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage ...[more]

PMID: 32168216

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Project description:IntroductionPercutaneous auricular nerve stimulation has been used for the treatment of symptoms associated with opioid withdrawal, including abdominal pain, nausea, and general discomfort. However, its potential utility for pain management and opioid minimization after surgery has not been investigated. The purpose of this study was to test the feasibility and acceptability of a trial protocol designed to assess the effectiveness of the NSS2-Bridge device as a non-pharmacologic alternative to opioids after cesarean delivery.MethodsIn a randomized control design, healthy women receiving cesarean delivery were randomized to receive the active device, placebo device, or no device. Devices were placed on the ear following cesarean delivery and left in place for 5 days. Feasibility and acceptability of the device was assessed by patient reports of device tolerability (rated on a 100mm visual analog scale where 0 is not tolerable at all and 100 is the most tolerable) as well as qualitative reporting. Additional outcomes assessed included proportion of patients not using opioids in hospital, as well as pain at rest, pain with movement, and total opioid consumption in the hospital and for the first 5 days after surgery.ResultsThere were 60 patients included in the final analysis. Device tolerability was rated highly, with an average daily score of >75 mm on the visual analog scale. The trial retention rate was 89.7% with most exclusions (42.9%) occurring due to unanticipated development of care complexity (e.g., hemorrhage and additional surgical procedures), with only 1 exclusion (14.3%) due to device discomfort. The active device group achieved the highest proportion of opioid-free hospitalizations (40%) compared to placebo (20%) and no device groups (30%). Pain at rest and with movement was similar between treatment groups.ConclusionsThis trial protocol designed to test the efficacy of NSS2-Bridge device for post-cesarean pain management is feasible and acceptable. Larger proportions of patients not using opioids in the active device group justifies additional investigation on device effectiveness in pregnant and postpartum people at highest risk for pain.

Project description:Objective Rectus muscle reapproximation at cesarean delivery (CD) is performed frequently by some obstetricians; however, the effect on postoperative pain is unclear. To this end, we investigated whether rectus muscle reapproximation increases postoperative pain. Materials and Methods This is a prospective, double-blind, randomized controlled trial of women undergoing primary CD with singleton or twin pregnancy at >35 weeks' gestation. Women were randomized to rectus muscle reapproximation with three interrupted sutures or no reapproximation. Exclusion criteria were prior cesarean, prior laparotomy, vertical skin incision, active labor, chronic analgesia use, allergy to opioid or nonsteroidal anti-inflammatory drugs, and body mass index ≥ 40. Intra- and postoperative pain management was standardized within the study protocol. The primary outcome was a combined movement pain and opioid use score averaged over the 72-hour study period, called the Silverman integrated assessment. Movement pain scores were assessed at 24, 48, and 72 postoperative hours. Results In total, 63 women were randomized, of whom 35 underwent rectus muscle reapproximation and 28 did not. Demographic and obstetric variables were similar between groups. Silverman integrated assessment scores during the 72-hour postoperative period were higher in the rectus muscle reapproximation group (15 ± 100% vs. -31 ± 78% difference from the mean; p = 0.04). Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes; p = 0.61), and there were no surgical complications in either group. Maternal satisfaction with analgesia at 72 hours was high in both groups (85% [73-90] rectus muscle reapproximation vs. 90% [75-100]; p = 0.16). Conclusion Rectus muscle reapproximation increased immediate postoperative pain without differences in operative time, surgical complications, or maternal satisfaction. Benefits of rectus muscle reapproximation should be weighed against increased postoperative pain, and analgesia should be planned accordingly.

Project description:BACKGROUND:Phenylephrine is the most commonly used vasopressor for prophylaxis against maternal hypotension during cesarean delivery; however, the best regimen for its administration is not well established. Although variable infusion protocols had been suggested for phenylephrine infusion, evidence-based evaluation of variable infusion regimens are lacking. The aim of this work is to compare variable infusion, fixed on-and-off infusion, and intermittent boluses of phenylephrine for prophylaxis against maternal hypotension during cesarean delivery. METHODS:A randomized controlled study was conducted, including full-term pregnant women scheduled for elective cesarean delivery. Participants were divided into three groups which received phenylephrine by either intermittent boluses (1.5 mcg/Kg phenylephrine), fixed on-and-off infusion (with a dose of 0.75 mcg/Kg/min), or variable infusion (with a starting dose of 0.75 mcg/Kg/min). The three groups were compared with regard to frequency of: maternal hypotension (primary outcome), second episode hypotension, reactive hypertension, and bradycardia. Other outcomes included heart rate, systolic blood pressure, physician interventions, and neonatal outcomes. RESULTS:Two-hundred and seventeen mothers were available for final analysis. The 2 infusion groups showed less incidence of maternal hypotension {26/70 (37%), 22/71 (31%), and (51/76 (67%)} and higher incidence of reactive hypertension compared to the intermittent boluses group without significant differences between the two former groups. The number of physician interventions was highest in the variable infusion group compared to the other two groups. The intermittent boluses group showed lower systolic blood pressure and higher heart rate compared to the two infusion groups; whilst the two later groups were comparable. CONCLUSION:Both phenylephrine infusion regimens equally prevented maternal hypotension during cesarean delivery compared to intermittent boluses regimen. Due to higher number of physician interventions in the variable infusion regimen, the current recommendations which favor this regimen over fixed infusion regimen might need re-evaluation.

Project description:ObjectiveTo evaluate whether there is a differential benefit of planned Cesarean delivery (CD) over planned vaginal delivery (VD) in women with a twin pregnancy and the first twin in cephalic presentation, depending on prespecified baseline maternal and pregnancy characteristics, and/or gestational age (GA) at delivery.MethodsThis was a secondary analysis of the Twin Birth Study, which included 2804 women with a twin pregnancy and the first twin (Twin A) in cephalic presentation between 32 + 0 and 38 + 6 weeks' gestation at 106 centers in 25 countries. Women were assigned randomly to either planned CD or planned VD. The main outcome measure was composite adverse perinatal outcome, defined as the occurrence of perinatal mortality or serious neonatal morbidity in at least one twin. The baseline maternal and pregnancy characteristics (markers) considered were maternal age, parity, history of CD, use of antenatal corticosteroids, estimated fetal weight (EFW) of Twin A, EFW of Twin B, > 25% difference in EFW between the twins, presentation of Twin B, chorionicity on ultrasound, method of conception, complications of pregnancy, ruptured membranes at randomization and GA at randomization. Separate logistic regression models were developed for each marker in order to model composite adverse perinatal outcome as a function of the specific marker, planned delivery mode and the interaction between these two terms. In addition, multivariable logistic regression analysis with backward variable elimination was performed separately in each arm of the trial. The association between planned mode of delivery and composite adverse perinatal outcome, according to GA at delivery, was assessed using logistic regression analysis.ResultsOf the 2804 women initially randomized, 1391 were included in each study arm. None of the studied baseline markers was associated with a differential benefit of planned CD over planned VD in the rate of composite adverse perinatal outcome. GA at delivery was associated differentially with composite adverse perinatal outcome in the treatment arms (P for interaction < 0.001). Among pregnancies delivered at 32 + 0 to 36 + 6 weeks, there was a trend towards a lower rate of composite adverse perinatal outcome in those in the planned-VD group compared with those in planned-CD group (29 (2.2%) vs 48 (3.6%) cases; odds ratio (OR) 0.62 (95% CI, 0.37-1.03)). In pregnancies delivered at or after 37 + 0 weeks, planned VD was associated with a significantly higher rate of composite adverse perinatal outcome, as compared with planned CD (23 (1.5%) vs 10 (0.7%) cases; OR, 2.25 (95% CI, 1.06-4.77)).ConclusionThe perinatal outcome of twin pregnancies with the first twin in cephalic presentation may differ depending on GA at delivery and planned mode of delivery. At 32-37 weeks, planned VD seems to be favorable, while, from around 37 weeks onwards, planned CD might be safer. The absolute risks of adverse perinatal outcomes at term are low and must be weighed against the increased maternal risks associated with planned CD. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:BackgroundThe effect of maternal amino acid (AA) infusion before and during cesarean delivery on neonatal temperature remains unknown. We hypothesized that thermogenic effects of AA metabolism would help maintain body temperature of newborn babies and their mothers.MethodsSeventy-six parturients scheduled for elective singleton term cesarean delivery were equally randomized to receive intravenous 200 ml of AA or placebo approximately 1 h before subarachnoid block (infusion rate:100 ml/h). The primary outcome was the newborn rectal temperature at 0, 5 and 10 min after birth. The secondary outcomes included the maternal rectal temperature at six time-points: T0 = before starting study solution infusion, T1 = 30 min after starting infusion, T2 = one hour after starting infusion, T3 = during spinal block, T4 = half an hour after spinal block, T5 = at the time of birth and T6 = at the end of infusion, as well as maternal thermal discomfort and shivering episodes.ResultsThere were no differences in newborn temperature between the two groups at any of the time-points (intervention-time-interaction effect, P = 0.206). The newborn temperature (mean [95%CI] °C) at birth was 37.5 [37.43-37.66] in the AA and 37.4 [37.34-37.55] in the placebo group. It showed a significant (P < 0.001) downward trend at 5 and 10 min after birth (time effect) in both groups. One neonate in the AA and five in the placebo group were hypothermic (temperature < 36.5 °C) (P = 0.20). There was a significant difference in the maternal temperature at all time points between the two groups (Intervention-time interaction effect, P < 0.001). However, after adjustment for multiplicity, the difference was significant only at T6 (P = 0.001). The mean difference [95%CI] in temperature decline from baseline (T0) till the end of infusion (T6) between the two groups was - 0.39 [- 0.55;- 0.22] °C (P < 0.0001). Six mothers receiving placebo and none receiving AA developed hypothermia (temperature < 36 °C) (P = 0.025). Maternal thermal discomfort and shivering episodes were unaffected by AA therapy.ConclusionsUnder the conditions of this study, maternal AA infusion before and during spinal anesthesia for cesarean delivery did not influence the neonatal temperature within 10 min after birth. In addition, the maternal temperature was only maintained at two hours of AA infusion.Trial registrationClinicalTrials.government, Identifier NCT02575170 . Registered on 10th April, 2015 - Retrospectively registered.

Project description:BackgroundAchieving optimal analgesia with few side effects is the goal of pain management after cesarean delivery. Intrathecal (IT) morphine is the current standard but ultrasound-guided quadratus lumborum block (QLB) may offer superior pain control with fewer side effects. This study compared the pain-free period after cesarean delivery among parturients who received spinal block with IT morphine, with IT morphine and bilateral QLB, or only bilateral QLB.MethodsParturients having elective cesarean delivery under spinal block were randomized and allocated into IT morphine 0.2 mg with sham QLB (Group IT), IT morphine 0.2 mg and bilateral QLB with 0.25% bupivacaine 25 ml in each side (Group IT+QLB), or bilateral QLB with 0.25% bupivacaine 25 ml in each side (Group QLB). A PCA pump was connected after completion of the QLB or sham block. The first time to PCA morphine requirement was recorded and compared.ResultsEighty parturients were included. Analysis of Group QLB was terminated early because at the second interim analysis, median pain-free period was significantly shorter in Group QLB [hours (95%CI): 2.50 (1.04-3.96) in Group IT vs. 7.75 (5.67-9.83) in IT+QLB vs. 1.75 (0.75-2.75) in QLB (p < 0.001)]. The median (min, max) amount of morphine required during 24 h was 5.5 (0-25) in Group IT vs. 5.0 (0-36) in IT+QLB vs. 17.5 (1-40) mg in Group QLB (p < 0.001). In the final analysis the median pain-free period was 2.50 (1.23-3.77) hours (95%CI) in Group IT (n = 27) vs. 8.02 (5.96-10.07) in IT+QLB (n = 28). (p = 0.027).ConclusionUS-QLB used in conjunction with IT morphine yielded a statistically significant longer median pain-free period compared with standard IT morphine alone. However, QLB alone provided inferior pain control compared with standard IT morphine. When combined with IT morphine, QLB could provide additional analgesic benefit as a part of multimodal analgesic regimen, especially during the early postoperative period.Trial registrationClinicalTrials.gov no. NCT03199170 Date registered on June 22, 2017. Prospectively registered.

Dataset Information

Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

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Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

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