Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

S. I. Stegwee, I. P. M. Jordans, L. F. van der Voet, M. Y. Bongers, C. J. M. de Groot, C. B. Lambalk, R. A. de Leeuw, W. J. K. Hehenkamp, P. M. van de Ven, J. E. Bosmans, E. Pajkrt, E. A. Bakkum, C. M. Radder, M. Hemelaar, W. M. van Baal, H. Visser, J. O. E. H. van Laar, H. A. A. M. van Vliet, R. J. P. Rijnders, M. Sueters, C. A. H. Janssen, W. Hermes, A. H. Feitsma, K. Kapiteijn, H. C. J. Scheepers, J. Langenveld, K. de Boer, S. F. P. J. Coppus, D. H. Schippers, A. L. M. Oei, M. Kaplan, D. N. M. Papatsonis, L. H. M. de Vleeschouwer, E. van Beek, M. N. Bekker, A. J. M. Huisjes, W. J. Meijer, K. L. Deurloo, E. M. A. Boormans, H. W. F. van Eijndhoven, J. A. F. Huirne

ABSTRACT

BACKGROUND: Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. METHODS: Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound. TRIAL REGISTRATION: Dutch Trial Register ( NTR5480 ). Registered 29 October 2015. More... »

PAGES

85

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12884-019-2221-y

DOI

http://dx.doi.org/10.1186/s12884-019-2221-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112527596

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30832681


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449 https://www.grid.ac/institutes/grid.414711.6 schema:alternateName Máxima Medisch Centrum
450 schema:name Department of Obstetrics and Gynaecology, Máxima Medical Centre, De Run 4600, 5504 DB, Veldhoven, the Netherlands
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452 https://www.grid.ac/institutes/grid.414725.1 schema:alternateName Meander Medisch Centrum
453 schema:name Department of Obstetrics and Gynaecology, Meander Medical Centre, Maatweg 3, 3813 TZ, Amersfoort, the Netherlands
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455 https://www.grid.ac/institutes/grid.415868.6 schema:alternateName Reinier de Graaf Hospital
456 schema:name Department of Obstetrics and Gynaecology, Reinier de Graaf hospital, Reinier de Graafweg 5, 2625 AD, Delft, the Netherlands
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458 https://www.grid.ac/institutes/grid.415930.a schema:alternateName Rijnstate Hospital
459 schema:name Department of Obstetrics and Gynaecology, Rijnstate hospital, Wagnerlaan 55, 6815 AD, Arnhem, the Netherlands
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461 https://www.grid.ac/institutes/grid.415960.f schema:alternateName St. Antonius Ziekenhuis
462 schema:name Department of Obstetrics and Gynaecology, Sint Antonius hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, the Netherlands
463 rdf:type schema:Organization
464 https://www.grid.ac/institutes/grid.440159.d schema:alternateName Flevoziekenhuis
465 schema:name Department of Obstetrics and Gynaecology, Flevo hospital, Hospitaalweg 1, 1315 RA, Almere, the Netherlands
466 rdf:type schema:Organization
467 https://www.grid.ac/institutes/grid.440209.b schema:alternateName Onze Lieve Vrouwe Gasthuis
468 schema:name Department of Obstetrics and Gynaecology, OLVG-west, Jan Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands
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470 https://www.grid.ac/institutes/grid.452600.5 schema:alternateName Isala
471 schema:name Department of Obstetrics and Gynaecology, Isala clinics, Dokter van Heesweg 2, 8025 AB, Zwolle, the Netherlands
472 rdf:type schema:Organization
473 https://www.grid.ac/institutes/grid.470077.3 schema:alternateName Ziekenhuis Bernhoven
474 schema:name Department of Obstetrics and Gynaecology, Bernhoven hospital, Nistelrodeseweg 10, 5406 PT, Uden, the Netherlands
475 rdf:type schema:Organization
476 https://www.grid.ac/institutes/grid.476832.c schema:alternateName Westfriesgasthuis
477 schema:name Department of Obstetrics and Gynaecology, Westfriesgasthuis, Maelsonstraat 3, 1624 NP, Hoorn, the Netherlands
478 rdf:type schema:Organization
479 https://www.grid.ac/institutes/grid.7177.6 schema:alternateName University of Amsterdam
480 schema:name Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands
481 rdf:type schema:Organization
 




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