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 11 Medical and Health Sciences 1114 Paediatrics and Reproductive Medicine

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 & 21 others 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

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number85
Pages (from-to)1-11
Number of pages11
JournalBMC Pregnancy and Childbirth
Volume19
DOIs
Publication statusPublished - 4 Mar 2019

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Reproductive Medicine
Cesarean Section
Multicenter Studies
Cicatrix
Randomized Controlled Trials
Metrorrhagia
Pediatrics
Myometrium
Health
Infertility
Sutures
Dysmenorrhea
Menstrual Cycle
Gestational Age
Obstetrics
Uterus
Cost-Benefit Analysis
Fertility
Gels
Quality of Life

Keywords

  • Caesarean section
  • Closure techniques
  • Fertility
  • Long-term outcomes
  • Niche
  • Postmenstrual spotting
  • Quality of life
  • Reproductive outcomes

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. ; Sueters, M. ; Janssen, C. A.H. ; Hermes, W. ; Feitsma, A. H. ; Kapiteijn, K. ; Scheepers, H. C.J. ; Langenveld, J. ; De Boer, K. ; Coppus, S. F.P.J. ; Schippers, D. H. ; Oei, A. L.M. ; Kaplan, M. ; Papatsonis, D. N.M. ; De Vleeschouwer, L. H.M. ; Van Beek, E. ; Bekker, M. N. ; Huisjes, A. J.M. ; Meijer, W. J. ; Deurloo, K. L. ; Boormans, E. M.A. ; Van Eijndhoven, H. W.F. ; Huirne, J. A.F. / 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 11 Medical and Health Sciences 1114 Paediatrics and Reproductive Medicine. In: BMC Pregnancy and Childbirth. 2019 ; Vol. 19. pp. 1-11.
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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",
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.}",
year = "2019",
month = "3",
day = "4",
doi = "10.1186/s12884-019-2221-y",
language = "English",
volume = "19",
pages = "1--11",
journal = "BMC Pregnancy and Childbirth",
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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 11 Medical and Health Sciences 1114 Paediatrics and Reproductive Medicine' BMC Pregnancy and Childbirth, vol. 19, 85, pp. 1-11. 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 11 Medical and Health Sciences 1114 Paediatrics and Reproductive Medicine. / 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.; Sueters, M.; Janssen, C. A.H.; Hermes, W.; Feitsma, A. H.; Kapiteijn, K.; Scheepers, H. C.J.; Langenveld, J.; De Boer, K.; Coppus, S. F.P.J.; Schippers, D. H.; Oei, A. L.M.; Kaplan, M.; Papatsonis, D. N.M.; De Vleeschouwer, L. H.M.; Van Beek, E.; Bekker, M. N.; Huisjes, A. J.M.; Meijer, W. J.; Deurloo, K. L.; Boormans, E. M.A.; Van Eijndhoven, H. W.F.; Huirne, J. A.F.

In: BMC Pregnancy and Childbirth, Vol. 19, 85, 04.03.2019, p. 1-11.

Research output: Contribution to JournalArticleAcademicpeer-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 11 Medical and Health Sciences 1114 Paediatrics and Reproductive Medicine

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

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U2 - 10.1186/s12884-019-2221-y

DO - 10.1186/s12884-019-2221-y

M3 - Article

VL - 19

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EP - 11

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

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