Prevalence of Intrauterine Adhesions After the Application of Hyaluronic Acid Gel After Dilatation and Curettage in Women With Spontaneous Abortion or Induction of Abortion From 12+0 Till 23+6 Week of Pregnancy.

Intrauterine adhesions 2020

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).

2021-09-28

2025-03-31

2025-04-01

Recruiting

Early phase I

200

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter prospective controlled study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participant will not be informed about usage of hyalobarier gel or not. Care provider - at the time of RCUI the surgeon will know from randomisation if apply the gel or not. The investigator performing evaluation of adhesions by hysteroscopy will be blinded to the arm which the participants belong to.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-13