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Levonorgestrel intrauterine device versus hysteroscopic resection in the management of patients with abnormal uterine bleeding secondary to cesarean section scar defect: a randomized controlled trial

A randomized controlled trial for levonorgestrel intrauterine device versus hysteroscopic resection in the management of patients with abnormal uterine bleeding secondary to cesarean section scar defect

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025677
Enrollment
Unknown
Registered
2019-09-05
Start date
2019-09-04
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Abnormal uterine bleeding secondary to cesarean section scar defect

Interventions

Treatment:Levonorgestrel intrauterine device
Control: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;

Secondary

MeasureTime frame
VAS Score;uterine bleeding;menstrual pattern;duration of the menstruation;pain;women’s satisfaction from her menstruation by Likert scale;Adverse effect;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 14, 2026