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Levonorgestrel intrauterine device versus hysteroscopic resection in the management of patients with abnormal uterine bleeding secondary associated with niche: a prospective cohort study

a prospective cohort study for levonorgestrel intrauterine device versus hysteroscopic resection in the management of patients with abnormal uterine bleeding secondary associated with niche

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042997
Enrollment
Unknown
Registered
2021-02-03
Start date
2018-07-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Abnormal uterine bleeding associated with niche

Interventions

LNG-IUD:Levonorgestrel intrauterine device
Hysteroscy:hysteroscopic resection

Sponsors

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 48 Years

Inclusion criteria

Inclusion criteria: The trial will include women aged 18-48 without fertility desire in the next year and having postmenstrual spotting after a CS, and in whom MRI has shown a defect of at least 2 mm depth and residual myometrium of at least 2.5 mm, and willing to sign inform consent form.

Exclusion criteria

Exclusion criteria: Women with an absolute contraindication for surgery, pregnancy, presence of an intrauterine device, previous menstrual irregularities, coagulation disorders, a (suspected) malignancy, submucosal fibroids, polyps, atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, hydrosalpinx that communicates with the uterus or an irregular cycle (>35 days or intercycle variation of 2 weeks or more).

Design outcomes

Primary

MeasureTime frame
Symptom improvement rate ;uterine bleeding;menstrual pattern;duration of the menstruation;

Secondary

MeasureTime frame
pain;women’s satisfaction from her menstruation by Likert scale;Cost-Effectiveness Ratio;incremental cost-effectiveness ratio;

Countries

China

Contacts

Public ContactJian Zhang

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University

ipmch@foxmail.com+86 18017316017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026