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 for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BackgroundDouble-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.MethodsWomen 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.DiscussionThis 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.

Original language	English
Article number	85
Number of pages	11
Journal	BMC Pregnancy and Childbirth
Volume	19
DOIs	https://doi.org/10.1186/s12884-019-2221-y
Publication status	Published - 4 Mar 2019

Keywords

Caesarean section
Closure techniques
Long-term outcomes
Postmenstrual spotting
Niche
Quality of life
Fertility
Reproductive outcomes
SECTION SURGICAL TECHNIQUES
QUALITY-OF-LIFE
ULTRASOUND EVALUATION
RESECTION
PREVALENCE
FACTORIAL
OUTCOMES
IMPACT
DEFECT
WOMEN

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10.1186/s12884-019-2221-yLicence: CC BY

Cite this

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, Article 85. https://doi.org/10.1186/s12884-019-2221-y

@article{7a7c7c44efed4a1bba4fba3076d7f2c6,

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 = "BackgroundDouble-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.MethodsWomen 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.DiscussionThis 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.",

keywords = "Caesarean section, Closure techniques, Long-term outcomes, Postmenstrual spotting, Niche, Quality of life, Fertility, Reproductive outcomes, SECTION SURGICAL TECHNIQUES, QUALITY-OF-LIFE, ULTRASOUND EVALUATION, RESECTION, PREVALENCE, FACTORIAL, OUTCOMES, IMPACT, DEFECT, WOMEN",

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.}",

note = "Funding Information: 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. Publisher Copyright: {\textcopyright} 2019 The Author(s).",

year = "2019",

month = mar,

day = "4",

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

language = "English",

volume = "19",

journal = "BMC Pregnancy and Childbirth",

issn = "1471-2393",

publisher = "BioMed Central Ltd",

}

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, 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, 85, 04.03.2019.

Research output: Contribution to journal › Article › 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.

N1 - Funding Information: 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. Publisher Copyright: © 2019 The Author(s).

PY - 2019/3/4

Y1 - 2019/3/4

N2 - BackgroundDouble-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.MethodsWomen 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.DiscussionThis 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.

AB - BackgroundDouble-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.MethodsWomen 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.DiscussionThis 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.

KW - Caesarean section

KW - Closure techniques

KW - Long-term outcomes

KW - Postmenstrual spotting

KW - Niche

KW - Quality of life

KW - Fertility

KW - Reproductive outcomes

KW - SECTION SURGICAL TECHNIQUES

KW - QUALITY-OF-LIFE

KW - ULTRASOUND EVALUATION

KW - RESECTION

KW - PREVALENCE

KW - FACTORIAL

KW - OUTCOMES

KW - IMPACT

KW - DEFECT

KW - WOMEN

U2 - 10.1186/s12884-019-2221-y

DO - 10.1186/s12884-019-2221-y

M3 - Article

C2 - 30832681

SN - 1471-2393

VL - 19

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

M1 - 85

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 Mar 4;19:85. doi: 10.1186/s12884-019-2221-y