Simulation TRaining for Operative vaginal Birth Evaluation:Study protocol for an observational stepped-wedge interrupted time-series study (STROBE)
| Autor: | Laura Timlin, Dimitrios Siassakos, Stephen O'Brien, Katie Cornthwaite, Sharon Jordan, Erik Lenguerrand, Christy Burden |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Forceps Episiotomy medicine.medical_specialty Neonatal intensive care unit Non-Randomized Controlled Trials as Topic medicine.medical_treatment Operative vaginal birth education Reproductive medicine Outcomes outcomes lcsh:Gynecology and obstetrics Study Protocol 03 medical and health sciences Shoulder dystocia 0302 clinical medicine Pregnancy medicine Humans Training Caesarean section General anaesthesia 030212 general & internal medicine Simulation Training lcsh:RG1-991 Ventouse 030219 obstetrics & reproductive medicine Obstetrics business.industry Obstetrics and Gynecology Interrupted Time Series Analysis forceps operative vaginal birth ventouse Delivery Obstetric medicine.disease Observational Studies as Topic Research Design Vagina Birth Female Observational study Apgar score business |
| Zdroj: | O'Brien, S, Lenguerrand, E, Jordan, S, Cornthwaite, K, Burden, C, Timlin, L & Siassakos, D 2019, ' Simulation TRaining for Operative vaginal Birth Evaluation : Study protocol for an observational stepped-wedge interrupted time-series study (STROBE) ', BMC Pregnancy and Childbirth, vol. 19, no. 1, 109 . https://doi.org/10.1186/s12884-019-2222-x BMC Pregnancy and Childbirth, Vol 19, Iss 1, Pp 1-7 (2019) BMC Pregnancy and Childbirth |
| DOI: | 10.1186/s12884-019-2222-x |
| Popis: | Background Operative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth. Methods The STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering. Discussion The STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth. Trial registration ISRCTN11760611 05/03/2018 (retrospectively registered). Electronic supplementary material The online version of this article (10.1186/s12884-019-2222-x) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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