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.

Status: Recruiting
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Contact Information
Primary
Jiri Hanacek, MD, Ph.D.
jiri.hanacek@upmd.eu
+420604154736
Time Frame
Start Date: 2021-09-28
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 200
Treatments
Active_comparator: Hyaluronic acid gel after D&C
After abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel.
Active_comparator: Only D&C
After abortion, in the II trimester, we provide only D\&C.
Related Therapeutic Areas
Sponsors
Collaborators: General University Hospital, Prague, Bulovka Hospital
Leads: Institute for the Care of Mother and Child, Prague, Czech Republic

This content was sourced from clinicaltrials.gov