Actively Recruiting

Phase 4
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT04671914

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

Led by Institute for the Care of Mother and Child, Prague, Czech Republic · Updated on 2024-05-13

200

Participants Needed

3

Research Sites

183 weeks

Total Duration

On this page

Sponsors

I

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

Lead Sponsor

B

Bulovka Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult women aged 18 to 40 years who wish to become pregnant in the future
  • Experienced a miscarriage in the second trimester of pregnancy (over 12 weeks)
  • Undergoing instrumental revision of the uterine cavity (RCUI)
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Younger than 18 years or older than 40 years
  • History of previous uterine surgery such as myomectomy, resection of intrauterine septum, or treatment for intrauterine adhesions
  • Suspected molar pregnancy
  • Signs of pelvic infection
  • Declined participation in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

1.Lf Uk, Vfn

Prague, Czechia, 12000

Actively Recruiting

2

Instiue for Care of Moher and Childe

Prague, Czechia, 14000

Actively Recruiting

3

FN Bulovka

Prague, Czechia, 14800

Actively Recruiting

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Research Team

J

Jiri Hanacek, MD, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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