Retained Products of Conception
Conditions
Keywords
Retained Products of Conception, Hysteroscopy, Intrauterine adhesion, Auto-crossed-linked hyaluronic acid gel
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.
Interventions
OTHERauto-crossed-linked hyaluronic acid gel
infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
Sponsors
Fu Xing Hospital, Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesion reformation rate at third-look hysteroscopy | A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification. |
| Adhesion score at third-look hysteroscopy | A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification. |
| Concentration of the menstrual pattern | at 3 months after the initial surgery |
| Pregnancy rate | at 12-month after the initial surgery |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complications | up to 12 weeks |
Countries
China
Contacts
Primary ContactXue Yang, Master
Backup ContactRong Li Huo, Doctor
Outcome results
None listed