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)

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Cited 6 times in Web of Science logo

Cited 6 times in Europe PMC logo

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This research has received a grant from the Instituto Carlos III (PI21/00972).

Analysis of institutional authors

Peguero, AnnaAuthorCobo TAuthorAldecoa VAuthorFigueras FAuthorPalacio MCorresponding AuthorGratacos EAuthor

October 7, 2021

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Publicated to:Bmj Open. 11 (9): e054711- - 2021-09-01 11(9), DOI: 10.1136/bmjopen-2021-054711

Authors: Cobo, Teresa; Aldecoa, Victoria; Bartha, Jose Luis; Bugatto, Fernando; Carrillo-Badillo, Maria Paz; Comas, Carmina; Diago-Almeda, Vicente; Ferrero, Silvia; Goya, Maria; Herraiz, Ignacio; Marti-Malgosa, Laia; Olivella, Anna; Paules, Cristina; Vives, Angels; Figueras, Francesc; Palacio, Montse; Gratacos, Eduard

Affiliations

CIBERER, Valencia, Spain - Author

Consorci Sanitari Terrassa, Terrassa, Spain - Author

Consorcio Corp Sanitaria Parc Tauli, Sabadell, Spain - Author

Hosp 12 Octubre, Inst Invest, Madrid, Spain - Author

Hosp 12 Octubre, Madrid, Spain - Author

Hosp Badalona Germans Trias & Pujol, Badalona, Spain - Author

Hosp Clin Barcelona, Barcelona, Spain - Author

Hosp Clin Univ Lozano Blesa, Zaragoza, Spain - Author

Hosp Santa Creu & Sant Pau, Barcelona, Spain - Author

Hosp St Joan de Deu, Barcelona, Spain - Author

Hosp Univ & Politecn La Fe, Valencia, Spain - Author

Hosp Univ La Paz, Madrid, Spain - Author

Hosp Univ Puerta Mar, Cadiz, Spain - Author

Hosp Univ Vall dHebron, Barcelona, Spain - Author

Hosp Univ Virgen de las Nieves, Granada, Spain - Author

Abstract

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.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 ?=0.05 and two-sided test, considering a dropout rate of 20%). Randomisation will be stratified by gestational age and centre.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.V.4 10 May 2021.NCT04831086 and Eudract number 2020-005202-26.© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

fetal medicineultrasonographyAmniocentesisCovid-19FemaleFetal medicineHospitalizationHumansInfant, newbornMaternal medicineMulticenter studies as topicObstetric labor, prematurePregnancyRandomized controlled trials as topicSars-cov-2Ultrasonography

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Bmj Open due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2021, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine (Miscellaneous).

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 3.18, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Aug 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-08-02, the following number of citations:

WoS: 6
Europe PMC: 6

Impact and social visibility

Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (Cobo Cobo, Maria Teresa) .