Clinical trial NCT05085067: The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception
Official title: The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retained Products of Conception
Keywords: Retained Products of Conception
Hysteroscopy
Intrauterine adhesion
Auto-crossed-linked hyaluronic acid gel
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Clinical diagnosis of retained products of conception
* Written consent obtained

Exclusion Criteria:

* Patients with severe complications of medicine and surgery
* Acute or chronic genital tract inflammation
* No understanding or approving the randomized controlled trial

Primary outcomes:
measure: Adhesion reformation rate at third-look hysteroscopy
timeFrame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
measure: Adhesion score at third-look hysteroscopy
timeFrame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
measure: Concentration of the menstrual pattern
timeFrame: at 3 months after the initial surgery
measure: Pregnancy rate
timeFrame: at 12-month after the initial surgery
Secondary outcomes:
measure: Rate of complications
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: FuxingHospital，Captital Medical University
state: Beijing
Study officials:
References: