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Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions

B

Barzilai Medical Center

Status

Unknown

Conditions

Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel

Treatments

Drug: Intrauterine injection of hyaluronic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04975373
0002-21

Details and patient eligibility

About

Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.

  1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
  2. control group - no injection

4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.

during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women undergoing hysteroscopic removal of retained placenta after delivery

Exclusion criteria

  • Known adverse reaction or allergy to hyaluronic acid

History of intrauterine adhesions

Acute pelvic inflammatory disease

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

study group
Other group
Description:
study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy
Treatment:
Drug: Intrauterine injection of hyaluronic acid
control group
No Intervention group
Description:
women will not receive hyaluronic acid after operative hysteroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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