Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorNadezhda Women's Health Hospital

About this trial

The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

female sex

infertility,

irregular bleeding,

oligo-/amenorrhea,

Disqualifiers

ongoing pregnancy,

genital cancer,

pelvic inflammatory disease,

excessive uterine bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Heparin solution

    Drug

    3 ml saline solution containing 5000 IU heparin.

  • Anti-adhesion barrier gel

    Drug

    2 ml biodegradable barrier gel containing sodium hyaluronate (10 mg/ml), sodium chloride (8.5 mg/ml), disodium hydrogen phosphate (0.34mg/ml), sodium dihydrogen phosphate (0.14 mg/ml) and water for injection (QS to weight).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Heparin solutionActive comparator 1 intervention
Group B: Anti-adhesion barrier gelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with post-operative intrauterine adhesion formation

Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia

Time frame
4 to 8 weeks post treatment
2

Number of patients with need for subsequent operative hysterectomy

Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery

Time frame
4 tot 8 weeks post treatment
3

Number of patients with persistent irregular menstrual bleeding

Recurring abnormal menstrual cycle patterns identified post initial surgery

Time frame
up to 12 months post treatment

Secondary outcomes

1

Number of patients with fertility improvement

Successful pregnancy post surgical procedure

Time frame
up to 12 months post treatment

Other outcomes

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