Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development – the 2Close study: a multicentre randomised controlled trial

BMC Pregnancy and Childbirth. 2019;19(1):1-11 DOI 10.1186/s12884-019-2221-y

 

Journal Homepage

Journal Title: BMC Pregnancy and Childbirth

ISSN: 1471-2393 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Gynecology and obstetrics

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS

S. I. Stegwee (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
I. P. M. Jordans (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
L. F. van der Voet (Department of Obstetrics and Gynaecology, Deventer Hospital)
M. Y. Bongers (Department of Obstetrics and Gynaecology, Máxima Medical Centre)
C. J. M. de Groot (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
C. B. Lambalk (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
R. A. de Leeuw (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
W. J. K. Hehenkamp (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)
P. M. van de Ven (Department of Epidemiology and Biostatistics, Vrije Universiteit Amsterdam)
J. E. Bosmans (Department of Health sciences, Faculty of Science, Research institute ‘Amsterdam Public Health’, Vrije Universiteit Amsterdam)
E. Pajkrt (Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam)
E. A. Bakkum (Department of Obstetrics and Gynaecology, OLVG-oost)
C. M. Radder (Department of Obstetrics and Gynaecology, OLVG-west)
M. Hemelaar (Department of Obstetrics and Gynaecology, Westfriesgasthuis)
W. M. van Baal (Department of Obstetrics and Gynaecology, Flevo hospital)
H. Visser (Department of Obstetrics and Gynaecology, Tergooi hospital)
J. O. E. H. van Laar (Department of Obstetrics and Gynaecology, Máxima Medical Centre)
H. A. A. M. van Vliet (Department of Obstetrics and Gynaecology, Catharina hospital)
R. J. P. Rijnders (Department of Obstetrics and Gynaecology, Jeroen Bosch hospital)
M. Sueters (Department of Obstetrics and Gynaecology, Leiden University Medical Centre)
C. A. H. Janssen (Department of Obstetrics and Gynaecology, Groene Hart hospital)
W. Hermes (Department of Obstetrics and Gynaecology, Haaglanden Medical Centre – Westeinde hospital)
A. H. Feitsma (Department of Obstetrics and Gynaecology, Haga hospital)
K. Kapiteijn (Department of Obstetrics and Gynaecology, Reinier de Graaf hospital)
H. C. J. Scheepers (Department of Obstetrics and Gynaecology, Research school ‘GROW’, Maastricht University Medical Centre)
J. Langenveld (Department of Obstetrics and Gynaecology, Zuyderland Medical Centre)
K. de Boer (Department of Obstetrics and Gynaecology, Rijnstate hospital)
S. F. P. J. Coppus (Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre)
D. H. Schippers (Department of Obstetrics and Gynaecology, Canisius-Wilhelmina hospital)
A. L. M. Oei (Department of Obstetrics and Gynaecology, Bernhoven hospital)
M. Kaplan (Department of Obstetrics and Gynaecology, Röpcke-Zweers hospital)
D. N. M. Papatsonis (Department of Obstetrics and Gynaecology, Amphia hospital)
L. H. M. de Vleeschouwer (Department of Obstetrics and Gynaecology, Sint Franciscus hospital)
E. van Beek (Department of Obstetrics and Gynaecology, Sint Antonius hospital)
M. N. Bekker (Department of Obstetrics and Gynaecology, Birth Centre Wilhelmina Children hospital/University Medical Centre Utrecht)
A. J. M. Huisjes (Department of Obstetrics and Gynaecology, Gelre hospital – location Apeldoorn)
W. J. Meijer (Department of Obstetrics and Gynaecology, Gelre hospital – location Zutphen)
K. L. Deurloo (Department of Obstetrics and Gynaecology, Diakonessenhuis)
E. M. A. Boormans (Department of Obstetrics and Gynaecology, Meander Medical Centre)
H. W. F. van Eijndhoven (Department of Obstetrics and Gynaecology, Isala clinics)
J. A. F. Huirne (Department of Obstetrics and Gynaecology, Research institutes ‘Amsterdam Cardiovascular Sciences’ and ‘Amsterdam Reproduction and Development’, Amsterdam UMC, Vrije Universiteit Amsterdam)

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 21 weeks

 

Abstract | Full Text

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.