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…
ID
Bron
Verkorte titel
Aandoening
Niche, Caesarean scar defect, Caesarean section, Ultrasound, Preeclampsia, Preterm birth. Niche, Defect sectiolitteken, Sectio Caesarea, Keizersnede, Echo, Pre-eclampsie, Vroeggeboorte.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Niche prevalence in the weeks/months after CS
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
3-4 days after CS (during hospitalization), 6 weeks (combined with visit outpatient clinic), 9 weeks, 12 weeks, 6 months, 12 months after CS.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Obstetrics and Gynaecology<br>
Postbus 7057
J.A.F. Huirne
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440090
j.huirne@vumc.nl
Wetenschappelijk
Department of Obstetrics and Gynaecology<br>
Postbus 7057
J.A.F. Huirne
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440090
j.huirne@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All women (>18 years old) who received a caesarean section in VU medical hospital.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Age under 18 years, insufficient comment of the Dutch language.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6743 |
NTR-old | NTR6921 |
CCMO | NL66399.029.18 |
OMON | NL-OMON48920 |