RT journal article
T1 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)
A1 Cobo, Teresa
A1 Aldecoa, Victoria
A1 Bartha Rasero, José Luis
A1 Bugatto González, Fernando
A1 Carrillo-Badillo, María Paz
A1 Comas, Carmina
A1 Diago-Almeda, Vicente
A1 Ferrero, Silvia
A1 Goya, María
A1 Herraiz, Ignacio
A1 Martí-Malgosa, Laia
A1 Olivella, Anna
A1 Paulés, Cristina
A1 Vives, Àngels
A1 Figueras, Francesc
A1 Palacio, Montse
A1 Gratacós, Eduard
A1 OPTIM-PTL group
A2 Materno-Infantil y Radiología
K1 maternal medicine
K1 fetal medicine
K1 ultrasonography
AB 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 alpha=0.05 and two-sided test, considering a dropout rate of 20%). Randomisation will be stratified by gestational age and centre.Ethics and dissemination Prior to receiving approval from the Ethics Committee (HCB/2020/1356) and the Spanish Agency of Medicines and Medical Devices (AEMPS) (identification number: 2020-005-202-26), the trial was registered in the European Union Drug Regulating Authorities Clinical Trials database (2020-005202-26). AEMPS approved the trial as a low-intervention trial. All participants will be required to provide written informed consent. Findings will be disseminated through workshops, peer-reviewed publications and national/international conferences. Protocol version V.4 10 May 2021.
PB BMJ PUBLISHING GROUP
SN 2044-6055
YR 2021
FD 2021-09
LK http://hdl.handle.net/10498/25869
UL http://hdl.handle.net/10498/25869
LA eng
NO This research has received a grant from the Instituto Carlos III (PI21/00972)
DS Repositorio Institucional de la Universidad de Cádiz
RD 11-nov-2026