|- candidate number||28366|
|- NTR Number||NTR6921|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2017|
|- Secondary IDs||2018.006 METC |
|- Public Title||SCAR-VIEW study|
|- Scientific Title||Niche development; time of onset after CS and its association with preterm birth and preeclampsia.|
|- ACRONYM||SCAR-VIEW study|
|- hypothesis||Many studies described a niche (defect of the uterine scar) to be visible after a prior caesarean section (CS) by using ultrasonography. The exact moment when a niche can be visualized and the best moment to evaluate it is unknown; most studies evaluate the CS scar between 3 to 12 months. Also, the precise pathophysiology underlying genesis of CS defects is uncertain. |
Preeclampsia and preterm birth are hypothesized to be associated with abnormal healing of the myometrium assuming that to cause niche development.
|- Healt Condition(s) or Problem(s) studied||Niche, Caesarean section, Caesarean section, Pre-eclampsia, Preterm birth, Ultrasound, Caesarean scar defect|
|- Inclusion criteria||All women (>18 years old) who received a caesarean section in VU medical hospital.|
|- Exclusion criteria||Age under 18 years, insufficient comment of the Dutch language.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jan-2019|
|- Target number of participants||85|
|- Interventions||Participants will receive 6 transvaginal ultrasounds in the first year after CS, at 3-4 days (baseling), 6, 9 and 12 weeks, 6 and 12 months. |
After analysis of the results of the first 10 participants, it will be decided whether to drop 1 or 2 time moments. In case no niche is observed during normal transvaginal ultrasound or the technique is inconclusive, a Saline Infusion Sonohysterography (SIS) or Gel Installation Sonography (GIS) will be performed.
|- Primary outcome||Niche prevalence in the weeks/months after CS|
|- Secondary outcome||Niche characteristics over time (length, depth, width, residual myometrium thickness, distance between niche and VV fold and distance between niche and external os).|
Determination of the moment after CS that a niche is visible with ultrasound.
|- Timepoints||3-4 days after CS (during hospitalization), 6 weeks (combined with visit outpatient clinic), 9 weeks, 12 weeks, 6 months, 12 months after CS.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. J.A.F. Huirne|
|- CONTACT for SCIENTIFIC QUERIES||drs. I.P.M. Jordans|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Many studies described niches (scar defect) to be visible after a prior caesarean section (CS) by using ultrasonography. The exact moment when a niche can be visualized and the best moment to evaluate it is unknown; most studies evaluate the CS scar between 3 to 12 months after CS.|
Also, the precise pathophysiology underlying genesis of CS scar defects is unknown, but it is likely to be related to abnormal healing of the myometrium. Some studies show that preeclampsia and preterm caesarean delivery are possibly related to disturbed healing and thereby development of a niche.
Objective of the study:
The aim of the study is to evaluate the time of occurrence of a niche in women who underwent a caesarean delivery; to evaluate changes of niche measurements over time and to determine the best moment in time after CS to evaluate the CS scar. Also, the influence of preeclampsia and preterm birth during the CS on the moment of niche development and its changes over time will be evaluated.
|- Main changes (audit trail)|
|- RECORD||21-dec-2017 - 8-jan-2018|