Primary Objective: * To evaluate the presence and time of occurrence of a niche in women who underwent a caesarean delivery Secondary Objective(s): * To evaluate changes of niche size and thickness of the residual myometrium over time* To determine…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Niche presence in the weeks/months after the CS.
Secondary outcome
- Niche characteristics over time (including length, depth, width, RMT, AMT,
distance between niche and VV fold, distance between niche and internal os)
- Determination of the best moment after CS to evaluate a niche and perform
measurements by using ultrasonography
- Evaluation of the influence of preeclampsia and preterm birth during the CS
on niche development and possible changes over time
Background summary
Evaluation of the uterine scar after caesarean section (CS) by using ultrasound
can detect niches (defects of the scar). The exact moment when a niche can be
visualized and when it is the best moment to evaluate a niche is unknown. The
origin of niches is hypothesized in literature. Preeclampsia and preterm birth
during the CS possibly influence niche development.
Study objective
Primary Objective:
* To evaluate the presence and time of occurrence of a niche in women who
underwent a caesarean delivery
Secondary Objective(s):
* To evaluate changes of niche size and thickness of the residual myometrium
over time
* To determine the best moment after CS to evaluate the CS scar and to perform
niche measurements
* To evaluate the influence of preeclampsia and preterm birth during the CS on
the moment of niche development and its changes over time
Study design
Prospective cohort study
Study burden and risks
Participants will receive 5-6 transvaginal ultrasounds. The first ultrasound
will be performed during hospitalisation after CS; the second will be combined
with the regulair outpatient control after CS. For the other 3-4 ultrasounds
participants will come extra to the hospital. There are no risks linked to
transvaginal ultrasound.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Patients who underwent their first CS (primary or secondary) in VUmc
- Sufficient command of the Dutch or English language
- * 18 years old
- Participants of the 2Close study, who agreed to undergo multiple ultrasounds
in the first year after CS (Amendment 7 of the 2Close study *The cost
effectiveness of double layer closure of the caesarean (uterine) scar in the
prevention of gynaecological symptoms in relation to niche development*,
registered at CCMO in ToetsingOnline (number NL55551.029.15) and at the METc
VUmc (protocol number 2015.462), describes the same study method as current
study. Data will be used in the SCAR-VIEW study. Sample size (n<=85) will not
change.)
Exclusion criteria
- Insufficient language comprehension
- Age < 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66399.029.18 |
| OMON | NL-OMON22134 |