The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFu Xing Hospital, Capital Medical University

About this trial

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.

After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: \[1\] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; \[2\] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of retained products of conception

Written consent obtained

Disqualifiers

Patients with severe complications of medicine and surgery

Acute or chronic genital tract inflammation

No understanding or approving the randomized controlled trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • auto-crossed-linked hyaluronic acid gel

    Other intervention

    infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Group A: no auto-cross linked hyaluronic acid gelNo intervention 0 interventions
Group B: Group B: infusing auto-cross linked hyaluronic acid gelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adhesion reformation rate at third-look hysteroscopy

Time frame
A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
2

Adhesion score at third-look hysteroscopy

Time frame
A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
3

Concentration of the menstrual pattern

Time frame
at 3 months after the initial surgery
4

Pregnancy rate

Time frame
at 12-month after the initial surgery

Secondary outcomes

1

Rate of complications

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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