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American Journal of Obstetrics and Gynecology

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Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE) - 20/07/22

Doi : 10.1016/j.ajog.2022.01.038 
Marion Groussolles, MD a, b, Norbert Winer, MD, PhD c, Loïc Sentilhes, MD, PhD d, Florence Biquart, MD d, Mona Massoud, MD e, Alexandre J. Vivanti, MD, PhD f, Hanane Bouchghoul, MD g, Patrick Rozenberg, MD, PhD h, Pascale Olivier, PharmD i, Raoul Desbriere, MD j, Celine Chauleur, MD, PhD k, Franck Perrotin, MD, PhD l, Frederic Coatleven, MD m, Florent Fuchs, MD, PhD n, Florence Bretelle, MD, PhD o, Vassilis Tsatsaris, MD, PhD p, q, Laurent J. Salomon, MD, PhD r, Nicolas Sananes, MD, PhD s, Gilles Kayem, MD, PhD t, Veronique Houflin-Debarge, MD, PhD u, Thomas Schmitz, MD, PhD v, Guillaume Benoist, MD w, Catherine Arnaud, MD, PHD b, x, Virginie Ehlinger, MSc b, Christophe Vayssière, MD, PhD a, b, ⁎
On behalf of the

Groupe de Recherche en Gynecologie Obstétrique

a Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital, Toulouse, France 
b Centre for Epidemiology and Research in Population Health, UMR 1295, Study of Perinatal, Pediatric and Adolescent Health: Epidemiological Research and Evaluation Team, Toulouse III University, Toulouse, France 
c Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d’Investigation Clinique Mere enfant, Nantes, France 
d Department of Obstetrics and Gynecology, Angers University Hospital, Angers, France 
e Department of Obstetrics and Gynecology, Hospital Femme-Mère-Enfant, University Lyon 1, Lyon, France 
f Hopital Antoine Beclere, Assistance Publique–Hôpitaux de Paris (AP-HP), Paris-Sud University, Clamart, France 
g Centre for Research in Epidemiology and Population Health, Hopital Bicetre and University of Paris-Saclay, Paris-Sud University, Université de Versailles Saint-Quentin-en-Yvelines, Institut National de la Santé et de la Recherche Médicale, Bicêtre, France 
h Department of Obstetrics and Gynecology, Poissy-Saint Germain Hospital & Versailles St-Quentin University, Research Unit EA 7285, Poissy, France 
i Department of Medical Pharmacology, Hospital Center University de Toulouse, Toulouse, France 
j Department of Obstetrics and Gynecology, Saint Joseph Hospital, Marseille, France 
k Department of Gynecology and Obstetrics, University Hospital of Saint-Etienne, Saint-Etienne, France 
l Department of Obstetrics and Gynecology, Tours University Hospital, Tours, France 
m Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France 
n Department of Obstetrics and Gynecology, Montpelier University Hospital, Montpellier, France 
o Department of Obstetrics and Gynecology, Marseille Nord Hospital, Assistance Publique – Hôpitaux de Marseille, Marseille, France 
p Port Royal Maternity Unit, Cochin Hospital, AP-HP, Paris, France 
q DHU Risks in Pregnancy, Paris Descartes University, Paris, France 
r Department of Obstetrics and Fetal Medicine, Necker-Enfants Malades Hospital, AP-HP, Paris Descartes University, Paris, France 
s Department of Maternal Fetal Medicine, Strasbourg University Hospital, Strasbourg, France 
t Department of Obstetrics and Gynecology, Trousseau Hospital, AP-HP, Paris, France 
u Department of Obstetrics and Gynecology, Jeanne de Flandre University Hospital, Lille, France 
v Department of Obstetrics and Gynecology, Hôpital Robert Debré, AP-HP, University Paris Diderot, Paris, France 
w Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France 
x Clinical Epidemiology Unit, Toulouse University Hospital Center, Toulouse, France 

∗Corresponding author: Christophe Vayssière, MD, PhD.

Abstract

Background

The number of twin pregnancies continues to increase worldwide as both the number of pregnancies obtained by medically assisted reproduction and age at first pregnancy keep rising. Preterm delivery is the major complication associated with twin pregnancies. The effectiveness of preventive treatments such as progesterone or cervical cerclage for women with a short cervix is doubtful in twin pregnancies. The effectivity of cervical pessaries in preventing preterm birth and its associated morbidity and mortality is also controversial.

Objective

We sought to investigate if the Arabin pessary reduces adverse neonatal outcomes in twin pregnancies with a short cervix.

Study Design

This open-label, multicenter, randomized controlled trial on twin pregnancies with a cervical length of <35 mm compared pessary placement at 16+0 to 24+0 weeks’ gestation with standard care alone. The primary endpoint was a composite of adverse neonatal outcomes, namely peripartum or neonatal death or significant neonatal morbidity before hospital discharge, defined as at least 1 of the following complications: bronchopulmonary dysplasia, intraventricular hemorrhage grade III to IV, periventricular leukomalacia, necrotizing enterocolitis grade II or higher, culture-proven sepsis, and retinopathy requiring treatment. A sample size of 308 pregnancies was planned to ensure 80% power to compare the proportions of women with at least 1 infant with an adverse neonatal outcome. The intention-to-treat analysis after multiple imputation of missing data, was supplemented with a secondary analysis that controlled for gestational age and cervical length, both at inclusion. The primary endpoint was also compared between randomization groups in the per-protocol population, which excluded patients with prespecified major protocol violations (mostly cervical cerclage and/or progesterone after inclusion). Secondary endpoints included preterm birth, spontaneous preterm birth, and pessary side effects.

Results

In total, 315 women were randomized to either receive a pessary (n=157) or standard management (n=158). Overall, 10.8% (34 women) of participants had a missing value for the primary endpoint, mostly (79%) because of the lack of paternal consent for neonatal data collection. In the intention-to-treat analysis, the adverse neonatal outcome occurred in 16.8% of the pessary group vs in 22.5% of the control group (risk ratio, 0.69; 95% confidence interval, 0.39–1.23; P=.210). The per-protocol analysis did not show any significant difference between groups (risk ratio, 0.78; 95% confidence interval, 0.47–1.28; P=.320). The occurrence of preterm birth or spontaneous preterm birth did not differ significantly between groups. No serious side effects were associated with pessary use.

Conclusion

Pessary use in our study did not significantly reduce adverse neonatal outcomes in twin pregnancies with a short cervix.

Le texte complet de cet article est disponible en PDF.

Key words : adverse neonatal outcomes, pessary, preterm birth, short cervix, twin pregnancies


Plan


 The authors report no conflict of interest.
 The French Ministry of Health (Programme Hospitalier de Recherche Clinique, AOM2013) supported this study, which was sponsored by the Department of Clinical Research of the Toulouse University Hospital Center, France. The funding source had no involvement in the study design, data collection, analysis and interpretation of data, writing of the report, or the decision to submit the article for publication.
 This trial was registered with ClinicalTrials.gov under identifier NCT02205541.
 Cite this article as: Groussolles M, Winer N, Sentilhes L, et al. Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE). Am J Obstet Gynecol 2022;227:271.e1-13.


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Vol 227 - N° 2

P. 271.e1-271.e13 - août 2022 Retour au numéro
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