RecruitingPhase 4NCT04671914

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

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.


Sponsor

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

Enrollment

200 participants

Start Date

Sep 28, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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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Interventions

DRUGHyaluronic Acid 20 MG/ML Injectable Solution

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

OTHERDilation and curretage

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


Locations(3)

1.Lf Uk, Vfn

Prague, Czechia

Instiue for Care of Moher and Childe

Prague, Czechia

FN Bulovka

Prague, Czechia

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NCT04671914


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