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Observational prospective cohort study of the niche with a long term follow up.

Niche cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20181
Enrollment
250
Registered
2017-12-18
Start date
2017-12-18
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Niche Caesarean scar defect.

Interventions

The aim of the study is to evaluate the effect of all applied types of interventions including expectant management on niche related symptoms and reproductive outcomes in a prospective way with long t

Sponsors

Vu medical center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women (>18 years) with the presence of a niche identified by TV sonography with a minimum depth of 2mm. Women may have or may not have symptoms (abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain, subfertility) . Women may or may not have a desire to conceive.

Exclusion criteria

Exclusion criteria: Age < 18 years or not able to understand Dutch or not able to complete questionnaires.

Design outcomes

Primary

MeasureTime frame
The effect on of various therapies or non-therapy on the main symptom or time to pregnancy in case of no symptoms.

Secondary

MeasureTime frame
days of postmenstrual spotting, dysmenorrhoe (VAS), chronic pelvic pain (VAS), time to conceive, time to ongoing pregnancy, pregnancy outcomes, niche characteristics by ultrasound, patients satisfaction and quality of life (SF36), complications, surgical complications, additional interventions.

Contacts

Public ContactJ.A.F. Huirne

VU Medical Center Department of Obstetrics and Gynaecology Postbus 7057

j.huirne@vumc.nl+31 (0)20 4440090

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)