Tocolysis in the management of preterm prelabor rupture of membranes at 22–33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM)

Kayem, Gilles; Lorthe, Elsa; Ancel, Pierre–Yves; Abdoul, Hendy; Briand, Nelly; Lehmann, Blandine; Cabanne, Clémence; Marret, Stéphane; L’Hélias, Laurence Foix; Goffinet, François; Schmitz, Thomas; Charlier, Caroline; Autret, Fanny; Azria, Élie; Balitalike, Jadot; Billiemaz, Kareen; Bohec, Caroline; Bolot, Pascal; Bornes, Marie; Bouchghoul, Hanane; Bourennane, Malek; Bretelle, Florence; Carbillon, Lionel; Castel, C.; Chauleur, Céline; Corroënne, Romain; Coste, Karen; Datin-Dorrière, Valérie; Desbrière, Raoul; Desfrère, Luc; Dreyfus, Michel; Dommergues, Marc; Durrmeyer, Xavier; Favrais, Géraldine; Flamant, Cyrille; Gallot, Denis; Gries, Julie; Haddad, Bassam; Julé, L; Laffaille, Cécile; Lepercq, J.; Letamendia, Emmanuelle; Marcillac, Fanny de; Miler, Caroline; Morel, Olivier; Karine, Norbert; Perrotin, Franck; Poncelet, C.; Renesme, Laurent; Roumegoux, Claire; Rozenberg, Patrick; Ruiz, Mireille; Sentilhes, Loïc; Sibiude, Jeanne; Subtil, D.; Tillouche, N.; Torchin, Héloïse; Tosello, Barthélémy; Verspyck, É.; Vivanti, Alexandre J.; Winer, Norbert

doi:10.1186/s12884-021-04047-2

Cited by 8 publications

(5 citation statements)

References 67 publications

(104 reference statements)

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“…Statistically, most cases of PROM occur at a GA of 25-32 weeks 48 , and approximately 60% of premature deliveries occur within the rst week after PROM 49 ; dysontogenetic newborns from these cases are extremely di cult to keep alive. A study conducted by the Lancet indicated that the survival rate of extremely preterm infants, de ned as being delivered before 28 weeks, was only 17%-41% and was accompanied by a disability rate of approximately 30% 50 .…”

Section: Discussionmentioning

confidence: 99%

Subaqueous Bioprinting: A Novel Strategy for Fetal Membrane Repair with 7‐Axis Robot‐Assisted Minimally Invasive Surgery

Zhao

et al. 2022

Adv Funct Materials

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Premature rupture of membranes (PROM), de ned as breakage of the amniotic sac prior to delivery, complicates 2-4% of pregnancies, leads to one-third of preterm births, and increases the risk of perinatal mortality and morbidity in survivors. In vivo bioprinting enables the fabrication of three-dimensional (3D) structures directly for tissue repair or reconstruction in living animals but is challenging to perform in the subaqueous narrow space where fetal membranes (FMs) are located. This study reports a novel strategy consisting of an ultrafast photoresponsive hydrogel (1.5 s) and a 7-axis bioprinting robot to perform subaqueous in vivo bioprinting in a minimally invasive approach. Specially, a hydrogel patch with designed gel rivets is printed subaqueously for the therapeutic needs of PROM, and the patch displays robust tissue adhesion, favorable biocompatibility, mechanical properties resembling native tissues, and an appropriate sealing timescale to prolong pregnancy. Experiments performed in an in vitro uterus model and a mid-gestational rabbit model show a favorable sealing effect for PROM, which validates the potential of our subaqueous bioprinting approach for application. This study not only expands upon in vivo bioprinting techniques but also provides valuable insights for the treatment of PROM and other diseases involving tissue injury in clinical settings.

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Section: Discussionmentioning

confidence: 99%

Subaqueous Bioprinting: A Novel Strategy for Fetal Membrane Repair with 7‐Axis Robot‐Assisted Minimally Invasive Surgery

Zhao

et al. 2022

Adv Funct Materials

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“…This illustrates the need for clinical practice guidelines that reflect rural and remote practice, for remote emergency clinicians (11). A clinical trial is currently investigating the risks and benefits of administering tocolysis after preterm prelabour rupture of membranes, with important implications for rural and remote maternity services (36).…”

Section: Discussionmentioning

confidence: 99%

Confinement or internment? Aeromedical retrieval of pregnant people in labour: A retrospective observational study

Honan¹,

Spring

Gardiner³

et al. 2022

Preprint

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Introduction: The aim of this study was to describe the characteristics and outcomes of remote dwelling pregnant people with threatened labour referred for aeromedical retrieval to a regional birthing centre, as well as factors associated with birth within 48 hours. Methods: This was a retrospective observational study of all pregnant people in the remote Central Australian region referred to the Medical Retrieval Consultation and Coordination Centre for labour >23 weeks gestation, between 12 February 2018 and 12 February 2020. Data was extracted manually from written medical records on maternal, neonatal and retrieval mission characteristics. Univariate and multivariate statistical analysis was performed. Results: There were 116 people referred for retrieval for labour. There were no births during transport and less than half of the cases in this cohort resulted in birth within 48 hours of retrieval. Tocolysis was frequently used. Predictors of birth with 48 hours were cervical dilatation 5cm or more, preterm gestational age and ruptured membranes in the univariate analysis. Nearly one-third of this cohort required intervention or had complications during birth. Discussion: Birth during transport for threatened labour did not occur in this cohort, and more than half of retrievals did not result in birth within 48 hours, however the high risk of birth complications may offset any benefit of avoiding aeromedical transport from remote regions. Retrieval clinicians should have a lower threshold for urgent transfer in cases of ruptured membranes, cervical dilatation of 5cm or more, or gestational age is less than 37 weeks.

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“…To emphasize, preterm birth is still a challenge to researchers studying its basic mechanisms, and though there have been some recent headways into its molecular pathways and prediction models [ 15 ], the question of when to start tocolytic therapy and for how long remains a common but difficult decision for clinicians. Currently, it is generally recommended that tocolysis be limited to the occurrence of preterm labor between the gestational ages (GA) of 24 weeks and 30 weeks or to those over 30 weeks of GA accompanied with cervical length <15 mm or 20 mm [ 4 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. The most acceptable strategy is acute tocolysis or 48 h of tocolytic agent use for steroid and magnesium sulphate (MgSO4) administration, as well as to gain time for maternal–fetal transfer [ 25 , 26 , 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

Tocolytic Treatment for the Prevention of Preterm Birth from a Taiwanese Perspective: A Survey of Taiwanese Obstetric Specialists

Lee

Yeh

Yang

et al. 2022

IJERPH

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Preterm birth represents a great burden to the healthcare system, resulting in the consideration for the use of tocolytic therapy to provide a “better time” for delivery in order to buy time to accelerate fetal lung maturity, thereby minimizing prematurity-related morbidity and mortality. However, the benefits and potential side effects and risks of tocolytic treatment for preterm birth should be carefully balanced. Although many countries and societies provide guidelines or consensuses for the management for preterm birth, there is no standardized national guideline or consensus in Taiwan. As such, great heterogeneity is suspected in preterm labor management, contributing to the uncertainty of attitudes and practice patterns of obstetric specialists in Taiwan. This study attempts to understand the attitudes and practice patterns regarding tocolytic therapy in Taiwan. A paper-based survey was conducted at the 2020 Taiwan Society of Perinatology Conference on 8 December 2020, exploring how obstetric specialists would use tocolytics under nine different clinical scenarios, such as a short cervix, preterm labor, maintenance tocolysis, preterm premature rupture of membranes, etc. Three hundred ten specialists attended the conference, and 77 responded to the survey with a response rate of 24.8%. According to the survey, many of these specialists would prescribe tocolytics for less evidence-based indications, including 22% for abdominal tightness, 46% for a short cervix, 60% for maintenance tocolysis, and 89% for repeat tocolysis, with the preferred first line medication being ritodrine and nifedipine. We concluded that tocolysis is widely accepted and practiced in Taiwan. More research is needed to include Taiwan-specific economic and cultural factors as well as associated adverse effects and patients’ outcomes.

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Tocolysis in the management of preterm prelabor rupture of membranes at 22–33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM)

Cited by 8 publications

References 67 publications

Subaqueous Bioprinting: A Novel Strategy for Fetal Membrane Repair with 7‐Axis Robot‐Assisted Minimally Invasive Surgery

Subaqueous Bioprinting: A Novel Strategy for Fetal Membrane Repair with 7‐Axis Robot‐Assisted Minimally Invasive Surgery

Confinement or internment? Aeromedical retrieval of pregnant people in labour: A retrospective observational study

Tocolytic Treatment for the Prevention of Preterm Birth from a Taiwanese Perspective: A Survey of Taiwanese Obstetric Specialists

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