ABSTRACT
BACKGROUND: The RemiPCA SAFE Network was established to set standards and monitor maternal and neonatal outcomes when using remifentanil for labour analgesia. The aim of this analysis was to describe the development of the network standard and to report maternal and neonatal outcome data, including severe adverse events. METHODS: Data sets of the RemiPCA SAFE Network database from the initial six consecutive years (2010-2015) were retrospectively analysed. The data were analysed on an annual basis and set in context with changes of the network standard, i.e. adaptations of the network's standard operating procedure. Main outcomes reported are maternal and neonatal data regarding effectiveness and safety, such as satisfaction, need for bag/mask ventilation and/or cardiopulmonary resuscitation. RESULTS: Among 5740 data sets, no need for maternal ventilation or cardiopulmonary resuscitation was registered. Neonatal cardiopulmonary resuscitations, potentially related to remifentanil, occurred in 0.3%. In parallel with adaptations of the network standard, a moderate rate of maternal hypoxia (oxygen saturation <94% in 24.7%) was found, together with a low rate of supplemental oxygen requirement in neonates (5.0%). CONCLUSION: The RemiPCA SAFE Network data show that remifentanil patient-controlled analgesia can be applied safely. There is bias when data from real clinical settings are analysed retrospectively. Notwithstanding, the approach taken by the RemiPCA SAFE Network, with constant, systematic and standardised evaluation of multiple parameters during the course of labour, might identify trends and anomalies and guide the development and application of safety standards, when translating knowledge from scientific trials into clinical practice.
Subject(s)
Analgesia, Obstetrical/adverse effects , Analgesia, Patient-Controlled/adverse effects , Analgesics, Opioid/adverse effects , Remifentanil/adverse effects , Analgesia, Epidural , Cardiopulmonary Resuscitation , Female , Humans , Infant, Newborn , Medical Audit , Patient Satisfaction , Pregnancy , Quality Assurance, Health Care , Retrospective Studies , Time FactorsSubject(s)
Analgesia, Obstetrical , Labor, Obstetric , Analgesia, Patient-Controlled , Female , Humans , Meperidine , Pain , Pregnancy , RemifentanilSubject(s)
Analgesia, Patient-Controlled/methods , Piperidines/administration & dosage , Female , Humans , Pregnancy , Registries , RemifentanilSubject(s)
Adipose Tissue/metabolism , Adrenocorticotropic Hormone/pharmacology , Isoproterenol/pharmacology , Lipolysis/drug effects , Protein Biosynthesis/drug effects , Adipose Tissue/drug effects , Animals , Cyclic AMP/metabolism , Cycloheximide/pharmacology , Glycerol/metabolism , Male , Puromycin/pharmacology , Rats , Rats, Inbred StrainsABSTRACT
Red blood cell 2,3-diphosphoglycerate (2,3-DPG) levels were studied in 227 normal gravid women in all stages of pregnancy, active labor, and early post partum. An increase to peak levels was observed at 19 to 22 weeks followed by a gradual fall toward normal. During labor and early post partum, 2,3-DPG again rose significantly above levels observed at term. Serial 2,3-DPG values through the third trimester, labor, and postpartum period in 11 hypertensive mothers and 20 normal gravid control subjects and their newborn infants were studied. Maternal 2,3-DPG levels were significantly higher in the hypertensive mothers when compared to control mothers at similar gestational stages. However, no difference in 2,3-DPG levels was observed when newborn infants of hypertensive mothers were compared with those of normal control subjects.
