Hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25033

Enrollment

100

Registered

2012-02-01

Start date

2012-02-01

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, Ceasarean section,Uterine rupture,Abnormale uterine bleeding, Hysteroscopic resection

Interventions

1. Hysteroscopic Nicheresection

2. Expectative, conservative policy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post menstrual spotting; 2. Niche with residual myometrium> 3mm and depth size > 2mm.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Age below 18 years; 3. Other disorders that may induce spotting; 4. Contra-indications for spinal or general anesthesia.

Design outcomes

Primary

Measure	Time frame
Postmenstrual spotting 6 months after randomization.	—

Secondary

Measure	Time frame
1. Quality of life; 2. Bleeding specific questionnaire; 3. Sexual function score; 4. VAS score; 5. Cost-effectiveness analysis.	—

Contacts

Public ContactA.J.M.W. Vervoort

Department of Obstetriscs and Gynaecology VU University Medical Center De Boelelaan 1117

aj.vervoort@vumc.nl+31 (0)20 4443613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)