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Recruiting Phase 4 NCT04671914

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

Trial Parameters

Condition Asherman Syndrome
Sponsor Institute for the Care of Mother and Child, Prague, Czech Republic
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex FEMALE
Min Age 18 Years
Max Age 40 Years
Start Date 2021-09-28
Completion 2025-03-31
Interventions
Hyaluronic Acid 20 MG/ML Injectable SolutionDilation and curretage

Brief 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).

Eligibility Criteria

Inclusion Criteria: * Adult (18 to 40 years) women with a wish for future pregnancy * abortion in the 2nd trimester of pregnancy (over 12 weeks of pregnancy) with instrumental revision of the uterine cavity (RCUI) * signed informed consent Exclusion Criteria: * age below 18 years, age over 40 years * history of previous uterine surgery (myomectomy, resection of the intrauterine septum, disruption of intrauterine adhesions) * suspected molar pregnancy * signs of pelvic infection * disagreement with participation in the study

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