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van CCT (UK)

van CCT (UK)

The cost effectiveness of surgical closure of the uterine scar during a caesarean section (CS) in 2 layers (compared with 1 layer closure) to prevent gynaecological symptoms associated with a defect in CS scar.

- candidate number23330
- NTR NumberNTR5480
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2015
- Secondary IDsNL80-84300-98-62021 ZonMW, MEC protocol number 2015.462, CCMO number 55551.029.15
- Public TitleThe cost effectiveness of surgical closure of the uterine scar during a caesarean section (CS) in 2 layers (compared with 1 layer closure) to prevent gynaecological symptoms associated with a defect in CS scar.
- Scientific TitleThe cost effectiveness of double layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development.
- ACRONYM2Close study
- hypothesisDouble layer closure of the uterine scar using unlocked continuous running sutures reduces menstrual disorders and pain and subfertility in relation to niche development and increases QOL and improves sexual functioning.
- Healt Condition(s) or Problem(s) studiedCaesarean section
- Inclusion criteriaWomen (18 years or older) undergoing their first caesarean section.
- Exclusion criteriaExclusion criteria include patients with previous uterine surgery, patients with known other factors causing menstrual disorders and patients with placenta percreta.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-mei-2016
- planned closingdate27-jun-2018
- Target number of participants2290
- InterventionsDouble layer closure (unlocked) continuous running suture of the uterus using multifilament material (instructed by e-learning) compared with usual (single layer) closure of the uterus, using a continuous running multifilament suture.
- Primary outcomePrimary outcome: post- and intermenstrual spotting 9 months after randomization.
- Secondary outcomeSecondary outcome: menstrual pattern (score card) and dysmenorhoe (VAS), Quality of life (SF36 & EQ-5D-5L), societal reintegration (PROMIS), sexual function (FSFI), Niche (characteristics), complications, surgery time and costs, % of ongoing pregnancies, life birth rate and time to conceive in women willing to conceive.
- TimepointsPrimary study parameter: Number of days of postmenstrual spotting 9 months after the CS, defined as intermenstrual (bleeding after at least 1 day without bleeding) or postmenstrual spotting (little amounts of red or brown blood loss immediately following normal menstruation) after 9 months.

Secondary study parameters:
- Intermediate (>2 days) or severe (>4 days) spotting and menstruation characteristics (menstrual score chart)
- Menstrual pain (VAS)
- QOL (SF36, EQ-5D-5L)
- Sexual function (FSFI)
- Societal reintegration (PROMIS; SF8a)
- Return to normal activities
- Existence of a niche (>2mm TV-US), large niches (>50% AND uterine wall< 3mm) and niche characteristics on TV-US including residual myometrium
- Peri-operative complications and surgery time
- Costs measured with a specifically adapted questionnaire (iMCQ) from a societal perspective
- Applied medical and surgical therapies because of niche related gynaecological symptoms within 9 months and 3 year follow-up

Of patients willing to conceive:
- Percentage of patients that conceived within 3 years follow-up.
- Percentage of patients with ongoing pregnancy within 3 years follow-up
- Time to conceive
- Applied therapies/interventions to improve fertility
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryDouble 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 (residual myometrium) and possibly decreases the development of niches. A niche is a CS defect at the site of the uterine scar and is associated with gynaecological symptoms including postmenstrual spotting (OR 3.1 (1.5 6.3)). It is also associated with failure of trail of labour after CS and possibly with subfertility. In the Netherlands single layer closure of the uterus is performed by 92% of the gynaecologists. In this study we will compare double layer closure with single layer closure of the (uterine) SC scar to study the effect on postmenstrual spotting 9 months after CS (primary outcome).
This is a multicenter trial which will be performed in the Netherlands.
- Main changes (audit trail)
- RECORD29-okt-2015 - 30-nov-2018

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