Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound PESAPRO Trial: study protocol for a randomized controlled trialReportar como inadecuado




Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound PESAPRO Trial: study protocol for a randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 16:427

First Online: 25 September 2015Received: 07 June 2015Accepted: 17 September 2015DOI: 10.1186-s13063-015-0964-y

Cite this article as: Cabrera-García, L., Cruz-Melguizo, S., Ruiz-Antorán, B. et al. Trials 2015 16: 427. doi:10.1186-s13063-015-0964-y

Abstract

BackgroundPremature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another.

Methods-DesignThe PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial RCT in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized 1:1 to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015.

DiscussionThis trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations.

Trial registrationEU Clinical Trials Register EudraCT2012-000241-13 Date of registration: 16 January 2012; ClinicalTrials.gov Identifier NCT01643980 Date of registration: 12 June 2012.

Keywordspremature birth short cervix vaginal progesterone cervical pessary prevention AbbreviationsCIconfidence interval

CMHCochran-Mantel-Haenszel

eCRFelectronic case report form

IDIBAPSInstitutd’investigacions Biomèdiques August Pi i Sunyer

ITTintention to treat

ISCIIIInstitute of Health Carlos III

PPper protocol

RCTrandomized clinical trials

RRrelative risk

SCReNSpanish Clinical Research Network

USultrasonography

USAUnited States of America

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Autor: Lourdes Cabrera-García - Sara Cruz-Melguizo - Belén Ruiz-Antorán - Ferrán Torres - Ana Velasco - Cristina Martínez-Payo

Fuente: https://link.springer.com/







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