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Title: | Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). |
Author: | Cobo, Teresa Aldecoa, Victoria Bartha, José Luis Bugatto, Fernando Carrillo Badillo, María Paz Comas, Carmina Diago Almeda, Vicente Ferrero, Silvia Goya, Maria Herraiz, Ignacio Martí Malgosa, Laia Olivella, Anna Paulés, Cristina Ferrero, Silvia Figueras Retuerta, Francesc Palacio, Montse Gratacós Solsona, Eduard OPTIM-PTL group |
Keywords: | Part prematur Avaluació del risc per la salut Líquid amniòtic Infeccions Serveis de salut maternal Corticosteroides Ecografia Premature labor Health risk assessment Amniotic liquid Infections Maternal health services Adrenocortical hormones Ultrasonic imaging |
Issue Date: | 28-Sep-2021 |
Publisher: | BMJ Publishing Group |
Abstract: | Introduction: The majority of women admitted with threatened preterm labour (PTL) do not delivery prematurely. While those with microbial invasion of the amniotic cavity (MIAC) represent the highest risk group, this is a condition that is not routinely ruled out since it requires amniocentesis. Identification of low-risk or high-risk cases might allow individualisation of care, that is, reducing overtreatment with corticosteroids and shorten hospital stay in low-risk women, while allowing early antibiotic therapy in those with MIAC. Benefits versus risks of amniocentesis-based predictor models of spontaneous delivery within 7 days and/or MIAC have not been evaluated. Methods and analysis: This will be a Spanish randomised, multicentre clinical trial in singleton pregnancies (23.0-34.6 weeks) with PTL, conducted in 13 tertiary centres. The intervention arm will consist in the use of amniocentesis-based predictor models: if low risk, hospital discharge within 24 hours of results with no further medication will be recommended. If high risk, antibiotics will be added to standard management. The control group will be managed according to standard institutional protocols, without performing amniocentesis for this indication. The primary outcome will be total antenatal doses of corticosteroids, and secondary outcomes will be days of maternal stay and the occurrence of clinical chorioamnionitis. A cost analysis will be undertaken. To observe a reduction from 90% to 70% in corticosteroid doses, a reduction in 1 day of hospital stay (SD of 2) and a reduction from 24% to 12% of clinical chorioamnionitis, a total of 340 eligible patients randomised 1 to 1 to each study arm is required (power of 80%, with type I error α=0.05 and two-sided test, considering a dropout rate of 20%). Randomisation will be stratified by gestational age and centre. |
Note: | Reproducció del document publicat a: https://doi.org/10.1136/bmjopen-2021-054711 |
It is part of: | BMJ Open, 2021, vol. 11, num. 9, p. e054711 |
URI: | http://hdl.handle.net/2445/196209 |
Related resource: | https://doi.org/10.1136/bmjopen-2021-054711 |
ISSN: | 2044-6055 |
Appears in Collections: | Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques) |
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