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)
| Autor: | Maria Goya, Carmen Garrido, Anna Peguero, Francesc Figueras, Eduard Gratacos, Cristina Paules, Eva Meler, Teresa Cobo, Victoria Aldecoa, Jose Luis Bartha, Fernando Bugatto, María Paz Carrillo-Badillo, Carmina Comas, Vicente Diago-Almeda, Silvia Ferrero, Ignacio Herraiz, Laia Martí-Malgosa, Anna Olivella, Àngels Vives, Montse Palacio, David Boada, Sara Ruiz-Martínez, Alberto Galindo, Laura Forcén, Patricia M Brañas, Itziar Garcia, Mirea Vargas, Alicia Martínez-Varea, Laia PratCorona, Marcos Cuerva, Tamara Illescas, Miguel Angel López-Guerrero, MºCarmen Facio, Carmen Medina, Cecilia Vilalain González |
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| Přispěvatelé: | Materno-Infantil y Radiología, Institut Català de la Salut, [Cobo T] Hospital Clinic de Barcelona, Barcelona, Spain. CIBERER, Valencia, Spain. [Aldecoa V] Hospital Clinic de Barcelona, Barcelona, Spain. [Bartha JL] Hospital Universitario La Paz, Madrid, Spain. [Bugatto F] Hospital Universitario Puerta del Mar, Cadiz, Spain. [Carrillo-Badillo MP] Hospital Universitario Virgen de las Nieves, Granada, Spain. [Comas C] Hospital Universitario Germans Trias i Pujol, Badalona, Spain. [Goya M] Vall d'Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Part prematur
Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores] fetal medicine Amniotic liquid law.invention Randomized controlled trial Part prematur - Prevenció Informed consent law Pregnancy Obstetrics and Gynaecology Premature labor Multicenter Studies as Topic media_common Avaluació del risc per la salut Randomized Controlled Trials as Topic Amniocentesi medicine.diagnostic_test diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::amniocentesis [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Ultrasonic imaging Adrenocortical hormones Gestational age General Medicine ultrasonography Infeccions Hospitalization Ecografia Maternal health services Amniocentesis Medicine Female Serveis de salut maternal medicine.medical_specialty enfermedades de los genitales femeninos y complicaciones del embarazo::complicaciones del embarazo::complicaciones del parto::parto prematuro [ENFERMEDADES] Infections Other subheadings::Other subheadings::/prevention & control [Other subheadings] Health risk assessment Obstetric Labor Premature medicine media_common.cataloged_instance Humans European union Protocol (science) maternal medicine business.industry Líquid amniòtic SARS-CoV-2 Female Urogenital Diseases and Pregnancy Complications::Pregnancy Complications::Obstetric Labor Complications::Obstetric Labor Premature [DISEASES] Infant Newborn COVID-19 medicine.disease Corticosteroides Clinical trial Emergency medicine Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Amniocentesis [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] business |
| Zdroj: | BMJ Open BMJ Open 2021;11:e054711 RODIN. Repositorio de Objetos de Docencia e Investigación de la Universidad de Cádiz instname BMJ Open, Vol 11, Iss 9 (2021) r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe Scientia |
| ISSN: | 2044-6055 |
| Popis: | 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. This research has received a grant from the Instituto Carlos III (PI21/00972) |
| Databáze: | OpenAIRE |
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