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Effect of Amniotic Membrane on Bleeding Control after Cervical LEEP

Investigating The Effect Of Amniotic Membrane On Hemostasis and recurrence After Loop Eletrosurgical Excision Procedure (LEEP) Conization: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260122068636N1
Enrollment
80
Registered
2026-01-29
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Postoperative bleeding.

Interventions

Intervention group: Application of amniotic membrane allograft at the surgical site according to protocol.

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Women aged 25 to 55 years Diagnosis of cervical intraepithelial neoplasia grade 2 or 3 Candidate for Loop Electrosurgical Excision Procedure conization Normal coagulation profile including PT and PTT Normal hemoglobin level Ability to provide written informed consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hemostasis level after cervical conization. Timepoint: During surgery and at 3, 6, and 24 hours after conization. Method of measurement: Menstrual pictogram (recording the amount of bleeding with each replacement of medium sanitary pad.;Pain level after cervical conization. Timepoint: 3, 6, and 24 hours after surgery. Method of measurement: Visual Analogue Scale for pain.;Cervical stenosis after conization. Timepoint: First menstrual cycle after surgery and three-month follow-up with colposcopy. Method of measurement: Colposcopy by gynecologic oncologist and menstrual pictogram completed by patient.;Recurrence of cervical intraepithelial neoplasia. Timepoint: 3, 6, and 12 months after surgery by colposcopy and pathology evaluation. Method of measurement: Colposcopy by the same gynecologic oncologist and pathology evaluation by the same pathologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Kamkari

Hamedan University of Medical Sciences

mehr@arakmu.ac.ir+98 81 3827 6055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026