Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial
Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar. Design Multicentre, double-blind, randomised controlled super...
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| creator | Stegwee, S.I Van der Voet, L.F Ben, A.J De Leeuw, R.A Van de Ven, P.M Duijnhoven, R.G Bongers, M.Y Lambalk, C.B De Groot, C.J.M Huirne, J.A.F van Vliet, Hubertus 2Close Study Grp, [missing] |
| description | Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
Design Multicentre, double-blind, randomised controlled superiority trial.
Setting Thirty-two hospitals in the Netherlands.
Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.
Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes. |
| format | Article |
| fullrecord | <record><control><sourceid>ghent</sourceid><recordid>TN_cdi_ghent_librecat_oai_archive_ugent_be_8741760</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>oai_archive_ugent_be_8741760</sourcerecordid><originalsourceid>FETCH-ghent_librecat_oai_archive_ugent_be_87417603</originalsourceid><addsrcrecordid>eNqdjUFqw0AMRb1ooWnTO2jZQgK2k8ah25DSA3RvxmPZUZFnjKQJpAfr-TqB9gIFgfT5-u_fFItq21Tr8qXe3xX3qp9lWe3qcrMovo_DgN4gDqAURsY1nFE0KfQxdVmyu6BAMhQKCJ6jJkHoU5YjeIfqBF0AzRCKAfLMUW3CoCbJMegcza6_T_Uhh_EZXmFKbOQxZOjqr6djCv0KxIU-TvSFPfgYTCJzPjXNuT8K2QVMyPGyuB0cKz7-7oeifjt-HN7X4yljW6ZO0Dtro6PWiT_RGds0Xq0O232zrZpduflX6Afy53I3</addsrcrecordid><sourcetype>Institutional Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial</title><source>Ghent University Academic Bibliography</source><source>Wiley</source><creator>Stegwee, S.I ; Van der Voet, L.F ; Ben, A.J ; De Leeuw, R.A ; Van de Ven, P.M ; Duijnhoven, R.G ; Bongers, M.Y ; Lambalk, C.B ; De Groot, C.J.M ; Huirne, J.A.F ; van Vliet, Hubertus ; 2Close Study Grp, [missing]</creator><creatorcontrib>Stegwee, S.I ; Van der Voet, L.F ; Ben, A.J ; De Leeuw, R.A ; Van de Ven, P.M ; Duijnhoven, R.G ; Bongers, M.Y ; Lambalk, C.B ; De Groot, C.J.M ; Huirne, J.A.F ; van Vliet, Hubertus ; 2Close Study Grp, [missing]</creatorcontrib><description>Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
Design Multicentre, double-blind, randomised controlled superiority trial.
Setting Thirty-two hospitals in the Netherlands.
Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.
Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.</description><identifier>ISSN: 1471-0528</identifier><identifier>ISSN: 1470-0328</identifier><language>eng</language><subject>Caesarean section ; CORONIS ; double layer ; FACTORIAL ; INCISION ; Medicine and Health Sciences ; niche ; OUTCOMES ; postmenstrual spotting ; PREVALENCE ; RISK-FACTORS ; SCAR ; single layer ; SYMPTOMS ; TERM ; uterine closure technique</subject><creationdate>2021</creationdate><rights>Creative Commons Attribution 4.0 International Public License (CC-BY 4.0) info:eu-repo/semantics/openAccess</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,315,780,784,4022,27859</link.rule.ids></links><search><creatorcontrib>Stegwee, S.I</creatorcontrib><creatorcontrib>Van der Voet, L.F</creatorcontrib><creatorcontrib>Ben, A.J</creatorcontrib><creatorcontrib>De Leeuw, R.A</creatorcontrib><creatorcontrib>Van de Ven, P.M</creatorcontrib><creatorcontrib>Duijnhoven, R.G</creatorcontrib><creatorcontrib>Bongers, M.Y</creatorcontrib><creatorcontrib>Lambalk, C.B</creatorcontrib><creatorcontrib>De Groot, C.J.M</creatorcontrib><creatorcontrib>Huirne, J.A.F</creatorcontrib><creatorcontrib>van Vliet, Hubertus</creatorcontrib><creatorcontrib>2Close Study Grp, [missing]</creatorcontrib><title>Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial</title><description>Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
Design Multicentre, double-blind, randomised controlled superiority trial.
Setting Thirty-two hospitals in the Netherlands.
Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.
Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.</description><subject>Caesarean section</subject><subject>CORONIS</subject><subject>double layer</subject><subject>FACTORIAL</subject><subject>INCISION</subject><subject>Medicine and Health Sciences</subject><subject>niche</subject><subject>OUTCOMES</subject><subject>postmenstrual spotting</subject><subject>PREVALENCE</subject><subject>RISK-FACTORS</subject><subject>SCAR</subject><subject>single layer</subject><subject>SYMPTOMS</subject><subject>TERM</subject><subject>uterine closure technique</subject><issn>1471-0528</issn><issn>1470-0328</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>ADGLB</sourceid><recordid>eNqdjUFqw0AMRb1ooWnTO2jZQgK2k8ah25DSA3RvxmPZUZFnjKQJpAfr-TqB9gIFgfT5-u_fFItq21Tr8qXe3xX3qp9lWe3qcrMovo_DgN4gDqAURsY1nFE0KfQxdVmyu6BAMhQKCJ6jJkHoU5YjeIfqBF0AzRCKAfLMUW3CoCbJMegcza6_T_Uhh_EZXmFKbOQxZOjqr6djCv0KxIU-TvSFPfgYTCJzPjXNuT8K2QVMyPGyuB0cKz7-7oeifjt-HN7X4yljW6ZO0Dtro6PWiT_RGds0Xq0O232zrZpduflX6Afy53I3</recordid><startdate>2021</startdate><enddate>2021</enddate><creator>Stegwee, S.I</creator><creator>Van der Voet, L.F</creator><creator>Ben, A.J</creator><creator>De Leeuw, R.A</creator><creator>Van de Ven, P.M</creator><creator>Duijnhoven, R.G</creator><creator>Bongers, M.Y</creator><creator>Lambalk, C.B</creator><creator>De Groot, C.J.M</creator><creator>Huirne, J.A.F</creator><creator>van Vliet, Hubertus</creator><creator>2Close Study Grp, [missing]</creator><scope>ADGLB</scope></search><sort><creationdate>2021</creationdate><title>Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial</title><author>Stegwee, S.I ; Van der Voet, L.F ; Ben, A.J ; De Leeuw, R.A ; Van de Ven, P.M ; Duijnhoven, R.G ; Bongers, M.Y ; Lambalk, C.B ; De Groot, C.J.M ; Huirne, J.A.F ; van Vliet, Hubertus ; 2Close Study Grp, [missing]</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-ghent_librecat_oai_archive_ugent_be_87417603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Caesarean section</topic><topic>CORONIS</topic><topic>double layer</topic><topic>FACTORIAL</topic><topic>INCISION</topic><topic>Medicine and Health Sciences</topic><topic>niche</topic><topic>OUTCOMES</topic><topic>postmenstrual spotting</topic><topic>PREVALENCE</topic><topic>RISK-FACTORS</topic><topic>SCAR</topic><topic>single layer</topic><topic>SYMPTOMS</topic><topic>TERM</topic><topic>uterine closure technique</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stegwee, S.I</creatorcontrib><creatorcontrib>Van der Voet, L.F</creatorcontrib><creatorcontrib>Ben, A.J</creatorcontrib><creatorcontrib>De Leeuw, R.A</creatorcontrib><creatorcontrib>Van de Ven, P.M</creatorcontrib><creatorcontrib>Duijnhoven, R.G</creatorcontrib><creatorcontrib>Bongers, M.Y</creatorcontrib><creatorcontrib>Lambalk, C.B</creatorcontrib><creatorcontrib>De Groot, C.J.M</creatorcontrib><creatorcontrib>Huirne, J.A.F</creatorcontrib><creatorcontrib>van Vliet, Hubertus</creatorcontrib><creatorcontrib>2Close Study Grp, [missing]</creatorcontrib><collection>Ghent University Academic Bibliography</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stegwee, S.I</au><au>Van der Voet, L.F</au><au>Ben, A.J</au><au>De Leeuw, R.A</au><au>Van de Ven, P.M</au><au>Duijnhoven, R.G</au><au>Bongers, M.Y</au><au>Lambalk, C.B</au><au>De Groot, C.J.M</au><au>Huirne, J.A.F</au><au>van Vliet, Hubertus</au><au>2Close Study Grp, [missing]</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial</atitle><date>2021</date><risdate>2021</risdate><issn>1471-0528</issn><issn>1470-0328</issn><abstract>Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
Design Multicentre, double-blind, randomised controlled superiority trial.
Setting Thirty-two hospitals in the Netherlands.
Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.
Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.</abstract><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1471-0528 |
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| source | Ghent University Academic Bibliography; Wiley |
| subjects | Caesarean section CORONIS double layer FACTORIAL INCISION Medicine and Health Sciences niche OUTCOMES postmenstrual spotting PREVALENCE RISK-FACTORS SCAR single layer SYMPTOMS TERM uterine closure technique |
| title | Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close) : multicenter, double-blind, randomized controlled superiority trial |
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