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

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

doi:10.1186/s12884-019-2221-y

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

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. SuetersC. 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 (Corresponding author)

Onderzoeksoutput: Bijdrage aan tijdschrift › Tijdschriftartikel › Academic › peer review

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Samenvatting

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.

Originele taal-2	Engels
Artikelnummer	85
Aantal pagina's	11
Tijdschrift	BMC Pregnancy and Childbirth
Volume	19
Nummer van het tijdschrift	1
DOI's	https://doi.org/10.1186/s12884-019-2221-y
Status	Gepubliceerd - 4 mrt. 2019

Financiering

This study group received a grant from The Netherlands Organisation for Health Research and Development (ZonMw, project number: 843002605, grant number: 80–84300–98-62021), a Dutch organization that supports research in health and health innovation. The funder peer-reviewed the study design and will receive an annual progress report of the trial, but has no further role in the collection, analysis and interpretation of data, writing of the manuscript or decision to submit the report for publication. 1Department 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. 2Department of Obstetrics and Gynaecology, Deventer Hospital, Nico Bolkesteinlaan 75, 7416 SE Deventer, the Netherlands. 3Department of Obstetrics and Gynaecology, Máxima Medical Centre, De Run 4600, 5504 DB Veldhoven, the Netherlands. 4Department of Epidemiology and Biostatistics, Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands. 5Department of Health sciences, Faculty of Science, Research institute ‘Amsterdam Public Health’, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands. 6Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. 7Department of Obstetrics and Gynaecology, OLVG-oost, Oosterpark 9, 1091 AC Amsterdam, the Netherlands. 8Department of Obstetrics and Gynaecology, OLVG-west, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands. 9Department of Obstetrics and Gynaecology, Westfriesgasthuis, Maelsonstraat 3, 1624 NP Hoorn, the Netherlands. 10Department of Obstetrics and Gynaecology, Flevo hospital, Hospitaalweg 1, 1315 RA Almere, the Netherlands. 11Department of Obstetrics and Gynaecology, Tergooi hospital, Rijksstraatweg 1, 1261 AN Blaricum, the Netherlands. 12Department of Obstetrics and Gynaecology, Catharina hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands. 13Department of Obstetrics and Gynaecology, Jeroen Bosch hospital, Henri Dunantstraat 1, 5223 GZ ‘s-Hertogenbosch, the Netherlands. 14Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands. 15Department of Obstetrics and Gynaecology, Groene Hart hospital, Bleulandweg 10, 2803 HH Gouda, the Netherlands. 16Department of Obstetrics and Gynaecology, Haaglanden Medical Centre – Westeinde hospital, Lijnbaan 32, 2512 VA Den Haag, the Netherlands. 17Department of Obstetrics and Gynaecology, Haga hospital, Els-Borst-Eilersplein 275, 2545 AA Den Haag, the Netherlands. 18Department of Obstetrics and Gynaecology, Reinier de Graaf hospital, Reinier de Graafweg 5, 2625 AD Delft, the Netherlands. 19Department of Obstetrics and Gynaecology, Research school ‘GROW’, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands. 20Department of Obstetrics and Gynaecology, Zuyderland Medical Centre, Henri Dunantstraat 5, 6419 PC Heerlen, the Netherlands. 21Department of Obstetrics and Gynaecology, Rijnstate hospital, Wagnerlaan 55, 6815 AD Arnhem, the Netherlands. 22Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, the Netherlands. 23Department of Obstetrics and Gynaecology, Canisius-Wilhelmina hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, the Netherlands. 24Department of Obstetrics and Gynaecology, Bernhoven hospital, Nistelrodeseweg 10, 5406 PT Uden, the Netherlands. 25Department of Obstetrics and Gynaecology, Röpcke-Zweers hospital, Jan Weitkamplaan 4a, 7772 SE Hardenberg, the Netherlands. 26Department of Obstetrics and Gynaecology, Amphia hospital, Langendijk 75, 4819 EV Breda, the Netherlands. 27Department of Obstetrics and Gynaecology, Sint Franciscus hospital, Kleiweg 500, 3045 PM Rotterdam, the Netherlands. 28Department of Obstetrics and Gynaecology, Sint Antonius hospital, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands. 29Department of Obstetrics and Gynaecology, Birth Centre Wilhelmina Children hospital/ University Medical Centre Utrecht, Lundlaan 6, 3584 EA Utrecht, the Netherlands. 30Department of Obstetrics and Gynaecology, Gelre hospital – location Apeldoorn, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, the Netherlands. 31Department of Obstetrics and Gynaecology, Gelre hospital – location Zutphen, Den Elterweg 77, 7207 AE Zutphen, the Netherlands.

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Stegwee, S. I., Jordans, I. P. M., van der Voet, L. F., Bongers, M. Y., de Groot, C. J. M., Lambalk, C. B., de Leeuw, R. A., Hehenkamp, W. J. K., Van De Ven, P. M., Bosmans, J. E., Pajkrt, E., Bakkum, E. A., Radder, C. M., Hemelaar, M., van Baal, W. M., Visser, H., van Laar, J. O. E. H., van Vliet, H. A. A. M., Rijnders, R. J. P., ... Huirne, J. A. F. (2019). 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, 19(1), Artikel 85. https://doi.org/10.1186/s12884-019-2221-y

@article{252ab3c1e18443f18a564b45f0986fc4,

title = "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",

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.",

keywords = "Caesarean section, Closure techniques, Fertility, Long-term outcomes, Niche, Postmenstrual spotting, Quality of life, Reproductive outcomes, Menstruation, Double-Blind Method, Endosonography, Cicatrix/diagnostic imaging, Humans, Cesarean Section/methods, Dysmenorrhea/etiology, Metrorrhagia/etiology, Randomized Controlled Trials as Topic, Pregnancy, Suture Techniques/adverse effects, Uterus/diagnostic imaging, Sexuality, Quality of Life, Female, Obstetric Labor Complications/etiology",

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

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doi = "10.1186/s12884-019-2221-y",

language = "English",

volume = "19",

journal = "BMC Pregnancy and Childbirth",

issn = "1471-2393",

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Stegwee, SI, Jordans, IPM, van der Voet, LF, Bongers, MY, de Groot, CJM, Lambalk, CB, de Leeuw, RA, Hehenkamp, WJK, Van De Ven, PM, Bosmans, JE, Pajkrt, E, Bakkum, EA, Radder, CM, Hemelaar, M, van Baal, WM, Visser, H, van Laar, JOEH, van Vliet, HAAM, Rijnders, RJP, Sueters, M, Janssen, CAH, Hermes, W, Feitsma, AH, Kapiteijn, K, Scheepers, HCJ, Langenveld, J, de Boer, K, Coppus, SFPJ, Schippers, DH, Oei, ALM, Kaplan, M, Papatsonis, DNM, de Vleeschouwer, LHM, van Beek, E, Bekker, MN, Huisjes, AJM, Meijer, WJ, Deurloo, KL, Boormans, EMA, van Eijndhoven, HWF & Huirne, JAF 2019, '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, vol. 19, nr. 1, 85. https://doi.org/10.1186/s12884-019-2221-y

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. / Stegwee, S. I.; Jordans, I. P.M.; van der Voet, L. F. et al.
In: BMC Pregnancy and Childbirth, Vol. 19, Nr. 1, 85, 04.03.2019.

Onderzoeksoutput: Bijdrage aan tijdschrift › Tijdschriftartikel › Academic › peer review

TY - JOUR

T1 - Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study

T2 - a multicentre randomised controlled trial

AU - Stegwee, S. I.

AU - Jordans, I. P.M.

AU - van der Voet, L. F.

AU - Bongers, M. Y.

AU - de Groot, C. J.M.

AU - Lambalk, C. B.

AU - de Leeuw, R. A.

AU - Hehenkamp, W. J.K.

AU - Van De Ven, P. M.

AU - Bosmans, J. E.

AU - Pajkrt, E.

AU - Bakkum, E. A.

AU - Radder, C. M.

AU - Hemelaar, M.

AU - van Baal, W. M.

AU - Visser, H.

AU - van Laar, J.O.E.H.

AU - van Vliet, H. A.A.M.

AU - Rijnders, R. J.P.

AU - Sueters, M.

AU - Janssen, C. A.H.

AU - Hermes, W.

AU - Feitsma, A. H.

AU - Kapiteijn, K.

AU - Scheepers, H. C.J.

AU - Langenveld, J.

AU - de Boer, K.

AU - Coppus, S. F.P.J.

AU - Schippers, D. H.

AU - Oei, A. L.M.

AU - Kaplan, M.

AU - Papatsonis, D. N.M.

AU - de Vleeschouwer, L. H.M.

AU - van Beek, E.

AU - Bekker, M. N.

AU - Huisjes, A. J.M.

AU - Meijer, W. J.

AU - Deurloo, K. L.

AU - Boormans, E. M.A.

AU - van Eijndhoven, H. W.F.

AU - Huirne, J. A.F.

PY - 2019/3/4

Y1 - 2019/3/4

N2 - 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.

AB - 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.

KW - Caesarean section

KW - Closure techniques

KW - Fertility

KW - Long-term outcomes

KW - Niche

KW - Postmenstrual spotting

KW - Quality of life

KW - Reproductive outcomes

KW - Menstruation

KW - Double-Blind Method

KW - Endosonography

KW - Cicatrix/diagnostic imaging

KW - Humans

KW - Cesarean Section/methods

KW - Dysmenorrhea/etiology

KW - Metrorrhagia/etiology

KW - Randomized Controlled Trials as Topic

KW - Pregnancy

KW - Suture Techniques/adverse effects

KW - Uterus/diagnostic imaging

KW - Sexuality

KW - Quality of Life

KW - Female

KW - Obstetric Labor Complications/etiology

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U2 - 10.1186/s12884-019-2221-y

DO - 10.1186/s12884-019-2221-y

M3 - Article

C2 - 30832681

AN - SCOPUS:85062425448

SN - 1471-2393

VL - 19

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

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ER -

Stegwee SI, Jordans IPM, van der Voet LF, Bongers MY, de Groot CJM, Lambalk CB et al. 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 mrt. 4;19(1):85. doi: 10.1186/s12884-019-2221-y