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Prevalence of Intrauterine Adhesions After D&C With or Without Antiadhesion Gel After Abortion in Second Trimester.

NCT04671914 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-05-13

No results posted yet for this study

Summary

Only patients who sign an informed consent will be included. Patients after a miscarriage in the 2nd trimester of pregnancy who need to perform an instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) will be randomized into two groups. In the first group, RCUI will be performed according to current standards. In the second group, an anti-adhesive preparation with hyaluronic acid (Hyalobarrier gel Endo) will be applied to the uterine cavity at the end of the RCUI procedure. Eight to twelve weeks after the operation, the occurrence of adhesions will be evaluated by ultrasound examination and diagnostic hysteroscopy (if adhesions will be detected, they will be disrupted). The study will also include the completion of a questionnaire in terms of the frequency and strength of the menstrual cycle. The presence of adhesions will be assessed according to The American Fertility Society (AFS).

Conditions

  • Asherman Syndrome
  • Abortion Late

Interventions

DRUG

Hyaluronic Acid 20 MG/ML Injectable Solution

Application of hyaluronic acid gel into uterine cavity after After abortion in II trimester we do D\&C

OTHER

Dilation and curretage

After abortion in II trimester we do D\&C.

Sponsors & Collaborators

  • Bulovka Hospital

    collaborator OTHER

  • General University Hospital, Prague

    collaborator OTHER

  • Institute for the Care of Mother and Child, Prague, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2025-03-31
Completion
2025-04-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671914 on ClinicalTrials.gov