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.

Autor: Stegwee SI; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., Jordans IPM; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., van der Voet LF; Department of Obstetrics and Gynaecology, Deventer Hospital, Nico Bolkesteinlaan 75, 7416 SE, Deventer, the Netherlands., Bongers MY; Department of Obstetrics and Gynaecology, Máxima Medical Centre, De Run 4600, 5504 DB, Veldhoven, the Netherlands.; Department of Obstetrics and Gynaecology, Research school 'GROW', Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands., de Groot CJM; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., Lambalk CB; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., de Leeuw RA; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., Hehenkamp WJK; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands., van de Ven PM; Department of Epidemiology and Biostatistics, Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV, Amsterdam, the Netherlands., Bosmans JE; Department of Health sciences, Faculty of Science, Research institute 'Amsterdam Public Health', Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, the Netherlands., Pajkrt E; Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Bakkum EA; Department of Obstetrics and Gynaecology, OLVG-oost, Oosterpark 9, 1091 AC, Amsterdam, the Netherlands., Radder CM; Department of Obstetrics and Gynaecology, OLVG-west, Jan Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands., Hemelaar M; Department of Obstetrics and Gynaecology, Westfriesgasthuis, Maelsonstraat 3, 1624 NP, Hoorn, the Netherlands., van Baal WM; Department of Obstetrics and Gynaecology, Flevo hospital, Hospitaalweg 1, 1315 RA, Almere, the Netherlands., Visser H; Department of Obstetrics and Gynaecology, Tergooi hospital, Rijksstraatweg 1, 1261 AN, Blaricum, the Netherlands., van Laar JOEH; Department of Obstetrics and Gynaecology, Máxima Medical Centre, De Run 4600, 5504 DB, Veldhoven, the Netherlands., van Vliet HAAM; Department of Obstetrics and Gynaecology, Catharina hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands., Rijnders RJP; Department of Obstetrics and Gynaecology, Jeroen Bosch hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, the Netherlands., Sueters M; Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands., Janssen CAH; Department of Obstetrics and Gynaecology, Groene Hart hospital, Bleulandweg 10, 2803 HH, Gouda, the Netherlands., Hermes W; Department of Obstetrics and Gynaecology, Haaglanden Medical Centre - Westeinde hospital, Lijnbaan 32, 2512 VA, Den Haag, the Netherlands., Feitsma AH; Department of Obstetrics and Gynaecology, Haga hospital, Els-Borst-Eilersplein 275, 2545 AA, Den Haag, the Netherlands., Kapiteijn K; Department of Obstetrics and Gynaecology, Reinier de Graaf hospital, Reinier de Graafweg 5, 2625 AD, Delft, the Netherlands., Scheepers HCJ; Department of Obstetrics and Gynaecology, Research school 'GROW', Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands., Langenveld J; Department of Obstetrics and Gynaecology, Zuyderland Medical Centre, Henri Dunantstraat 5, 6419 PC, Heerlen, the Netherlands., de Boer K; Department of Obstetrics and Gynaecology, Rijnstate hospital, Wagnerlaan 55, 6815 AD, Arnhem, the Netherlands., Coppus SFPJ; Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands., Schippers DH; Department of Obstetrics and Gynaecology, Canisius-Wilhelmina hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands., Oei ALM; Department of Obstetrics and Gynaecology, Bernhoven hospital, Nistelrodeseweg 10, 5406 PT, Uden, the Netherlands., Kaplan M; Department of Obstetrics and Gynaecology, Röpcke-Zweers hospital, Jan Weitkamplaan 4a, 7772 SE, Hardenberg, the Netherlands., Papatsonis DNM; Department of Obstetrics and Gynaecology, Amphia hospital, Langendijk 75, 4819 EV, Breda, the Netherlands., de Vleeschouwer LHM; Department of Obstetrics and Gynaecology, Sint Franciscus hospital, Kleiweg 500, 3045 PM, Rotterdam, the Netherlands., van Beek E; Department of Obstetrics and Gynaecology, Sint Antonius hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, the Netherlands., Bekker MN; Department of Obstetrics and Gynaecology, Birth Centre Wilhelmina Children hospital/University Medical Centre Utrecht, Lundlaan 6, 3584 EA, Utrecht, the Netherlands., Huisjes AJM; Department of Obstetrics and Gynaecology, Gelre hospital - location Apeldoorn, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, the Netherlands., Meijer WJ; Department of Obstetrics and Gynaecology, Gelre hospital - location Zutphen, Den Elterweg 77, 7207 AE, Zutphen, the Netherlands., Deurloo KL; Department of Obstetrics and Gynaecology, Diakonessenhuis, Bosboomstraat 1, 3582 KE, Utrecht, the Netherlands., Boormans EMA; Department of Obstetrics and Gynaecology, Meander Medical Centre, Maatweg 3, 3813 TZ, Amersfoort, the Netherlands., van Eijndhoven HWF; Department of Obstetrics and Gynaecology, Isala clinics, Dokter van Heesweg 2, 8025 AB, Zwolle, the Netherlands., Huirne JAF; Department of Obstetrics and Gynaecology, Research institutes 'Amsterdam Cardiovascular Sciences' and 'Amsterdam Reproduction and Development', Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands. j.huirne@vumc.nl.
Jazyk: angličtina
Zdroj: BMC pregnancy and childbirth [BMC Pregnancy Childbirth] 2019 Mar 04; Vol. 19 (1), pp. 85. Date of Electronic Publication: 2019 Mar 04.
DOI: 10.1186/s12884-019-2221-y
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje