Intra-uterine Adhesions Clinical Trial
Official title:
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
| NCT number | NCT03881215 |
| Other study ID # | AS1811 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2016 |
| Est. completion date | January 10, 2020 |
| Verified date | January 2020 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | January 10, 2020 |
| Est. primary completion date | December 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Age: 18-40 years - Grade III intra-uterine adhesions Exclusion Criteria: - Age < 18 or > 40 years. - Hb < 11 g/dL, platelets < 150.000/mm3. - Patient taking anticoagulant. - Patient taking NSAID in the 10 days before procedure. - Any significant comorbidity or psychiatric disorder that would compromise patient's consent. - Active cervical or uterine infection. - Undiagnosed genital bleeding. - pregnancy. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ain Shams University Maternity Hospital | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adhesion recurrence | recurrence of severe intra-uterine adhesions | 3 months | |
| Secondary | Days of menses | Number of days of menstrual cycle following operation | 3 months | |
| Secondary | Amount of menses | Number of sanitary pads changed during each menstrual cycle | 3 months |