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Intrauterine cleaning after placental delivery at cesarean section: a randomized controlled trial.

ABSTRACT: OBJECTIVE:The objective of this study is to evaluate whether omission of intrauterine cleaning increases intraoperative and postoperative complications among women who deliver via cesarean section. METHODS:We randomized 206 women undergoing primary elective cesarean deliveries to intrauterine cleaning or omission of cleaning. Postpartum endomyometritis rates across groups were the primary outcome. We also examined secondary outcomes. To detect a 20% difference in infection rate between the cleaned and the non-cleaned groups (two-tailed [alpha]?=?0.05, [beta]?=?0.2), 103 women were required per group. Analysis was by intention-to-treat. RESULTS:Two hundred and six were randomized as follows: 103 to intrauterine cleaning and 103 to omission of cleaning after placental delivery. There were no statistically significant differences in the rate of endomyometritis between the two groups (2.0% versus 2.9%, RR =0.60; 95% CI 0.40-1.32). There were no statistically significant differences in postpartum hemorrhage rates (5.8% versus 7.7%, RR 0.75; 95% CI 0.6-1.2), hospital readmission rates (2.9 versus 3.8%, RR 0.75; 95% CI 0.5-1.6), time to return of gastrointestinal function, need for repeat surgery, or quantitated blood loss between the two groups. CONCLUSIONS:Our randomized controlled trial provides evidence suggesting that omission of intrauterine cleaning during cesarean deliveries in women at low risk of infection does not increase intraoperative or postoperative complications.

SUBMITTER: Eke AC

PROVIDER: S-EPMC6363334 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Intrauterine cleaning after placental delivery at cesarean section: a randomized controlled trial.

Eke Ahizechukwu C AC Drnec Sheila S Buras Andrea A Woo Joanna J Martin Denny D Roth Steven S

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 20170919 2

<h4>Objective</h4>The objective of this study is to evaluate whether omission of intrauterine cleaning increases intraoperative and postoperative complications among women who deliver via cesarean section.<h4>Methods</h4>We randomized 206 women undergoing primary elective cesarean deliveries to intrauterine cleaning or omission of cleaning. Postpartum endomyometritis rates across groups were the primary outcome. We also examined secondary outcomes. To detect a 20% difference in infection rate be ...[more]

PMID: 28889781

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Project description:BackgroundLoss of resistance (LOR) technique is a widely used method to identify the epidural space. However, cases of inadequate epidural anesthesia in cesarean section were frequently reported. Also, the success rate of epidural anesthesia with LOR technique varied depending on the proficiency of the practitioner. The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section for novices or clinicians with recent gap in experience.MethodsPregnant women scheduled for elective cesarean section were randomly allocated to two groups. Groups were classified based on the methods used for identifying the epidural space: the LOR group (group L) and the LOR with epidural electrical stimulation group (group E). Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section. In the group E, a RegionalStim® conductive catheter was inserted through the Tuohy needle, and the guidewire passing through the catheter was connected to a peripheral nerve stimulator. The intensity of the stimulation was gradually increased from 0.25 mA to 1.5 mA until paresthesia was elicited and radiated. We assessed the success of epidural anesthesia (complete success, partial success or failure). Other clinical parameters including maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events were compared between the two groups.ResultsExcept for 6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E). The demographic data showed no difference between the two groups. There was no adverse event resulted from electrical stimulation. The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively). The other clinical parameters showed no differences between the two groups.ConclusionIn addition to the conventional LOR technique, identifying epidural spaces using electrical stimulation led to better outcomes without additional risks for novices as well as clinicians with recent gap in experience.Trial registrationThis study was retrospectively registered in the ClinicalTrials.gov Registry (NCT03443466) on February 23, 2018.

Project description:BACKGROUND:Evidence increases that a high or a standard dose of tranexamic acid (TA) reduces postpartum bleeding. The TRACES pharmacobiological substudy aims to establish a therapeutic strategy in hemorrhagic (H) Cesarean section (CS) with respect to the intensity of fibrinolysis by using innovative assays. METHOD/DESIGN:The TRACES trial is a multicenter, randomized, double-blind, placebo-controlled, TA dose-ranging study that measures simultaneously plasmatic and uterine and urine TA concentrations and the plasmin peak inhibition tested by a simultaneous thrombin plasmin generation assay described by Van Geffen (novel hemostasis assay [NHA]). Patients undergoing H CS (>800 mL) will receive blindly TA 0.5 g or 1 g or placebo. A non-hemorrhagic (NH) group will be recruited to establish plasmin generation profile. Venous blood will be sampled before, at the end, and then at 30, 60, 120, and 360 min after injection. Uterine bleeding will be sampled after injection. Urine will be sampled 2 h and 6 h after injection. The number of patients entered into the study will be 114 H + 48 NH out of the 390 patients of the TRACES clinical trial. DISCUSSION:To explore the two innovative assays, a preliminary pilot study was conducted. Blood samples were performed repeatedly in patients undergoing either a H (>800 mL) or NH (<800 mL) CS and in non-pregnant women (NP). H patients received TA (0-2 g). Dose-dependent TA plasmatic concentrations were determined by LC-MS/MS quantification. Plasmin generation and its inhibition were tested in vitro and in vivo using the simultaneous thrombin-plasmin generation assay (STPGA). The pilot study included 15 patients in the H group, ten patients in the NH group, and seven patients in the NP group. TA plasmatic concentration showed a dose-dependent variation. STPGA inter-assay variation coefficients were < 20% for all plasmin parameters. Inter-individual dispersion of plasmin generation capacity was higher in H and NH groups than in NP group. Profile evolution over time was different between groups. This preliminary technical validation study allows TRACES pharmacobiological trial to be conducted. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02797119. Registered on 13 June 2016.

Project description:BackgroundAnticoagulant therapy during pregnancy is widely used due to the increasing awareness of maternal hypercoagulability. Few studies have reported the use of minimally invasive spinal anesthesia in these parturients. The objective of this study was to evaluate the safety and feasibility of minimally invasive spinal anesthesia in parturients with anticoagulation therapy undergoing cesarean section.MethodsThis was a randomized, controlled study conducted in 239 parturients using anticoagulants and undergoing selective cesarean section. 37 parturients withdrew, and finally parturients received spinal anesthesia using 27gauge pen type fine spinal needles (experimental group, n = 110) and 22gauge traditional spinal needles (control group, n = 92). The primary efficacy outcomes included low back pain (LBP) and postdural puncture headache (PDPH) after delivery. Secondary efficacy outcomes included visual analogue scale during subarachnoid puncture (VASdural), difference between visual analogue scale (VAS) during peripheral venipuncture and VASdural (∆VAS), VAS of back puncture point 24, 48 and 72 h after operation (VASdural-24 h, VASdural-48 h and VASdural-72 h, respectively), maternal satisfaction and hospitalization stay.ResultsNo parturient had PDPH and was suspected with spinal or intracranial haematoma in two groups. There was no significant difference in VASlbp-24 h, VASlbp-48 h and VASlbp-72 h (P = 0.056; P = 0.813; P = 0.189, respectively) between two groups. In experimental group, VASdural (P = 0.017), ∆VAS (P = 0.001) and VASdural-24 h (P < 0.0001) were lower, whereas maternal satisfaction was higher (P = 0.046). There was no significant difference in VASdural-48 h, VASdural-72 h, urination function, strength recovery and hospitalization stay (P = 0.069; P = 0.667; P = 0.105; P = 0.133; P = 0.754, respectively) between the two groups.ConclusionsMinimally invasive spinal anesthesia provided lower VASdural, VASdrual-24 h and a higher maternal satisfaction. Hence, it is considered as a safe, reliable and reasonable option for cesarean section parturients during maternal anticoagulation therapy with normal platelet count and coagulation time.Trial registrationThis study was registered at www.ClinicalTrials.gov at November 11th, 2016 ( NCT02987192 ).

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.

Dataset Information

Intrauterine cleaning after placental delivery at cesarean section: a randomized controlled trial.

Publications

Intrauterine cleaning after placental delivery at cesarean section: a randomized controlled trial.

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