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Niche development in the first year after a caesarean section and the influence of preterm birth and preeclampsia

Niche development in the first year after a caesarean section and the influence of preterm birth and preeclampsia - SCAR-VIEW study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48920
Enrollment
85
Registered
2019-03-05
Start date
2019-05-06
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean scar defect isthmocele

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Insufficient language comprehension - Age

Design outcomes

Primary

MeasureTime frame
Niche presence in the weeks/months after the CS.

Secondary

MeasureTime frame
- 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)