To examine the effectiveness of intrauterine alginate carboxymethycellulose hyaluronic acid gel application after vacuum aspiration in order to reduce the formation and severity of intrauterine adhesions
Conditions
Interventions
Intervention: Alginate carboxymethylcellulose hyaluronic acid gel
Control: no treatment
Sponsors
Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients who were diagnosed of blighted ovum or incomplete abortions or inevitable abortions or embryonic death and underwent termination of pregnancy by manual or electric vacuum aspiration. The inclusion criteria included pregnant patient with gestational age of 13 weeks or less without history of uterine curettage, pelvic infection, clinical evidence of genital tract cancer, intrauterine surgery, IUD used, uterine anomaly, endometriosis, and intolerance or hypersensitivity to ACH gel and its derivatives. All participants agreed to use condom as contraception during the follow up period.
Exclusion criteria
Exclusion criteria: The exclusion criteria included hormonal contraception used, pregnant before the scheduled of hysteroscopy, the complication occurred during or after the procedure such as uterine perforation, infection, incomplete abortion, or need to D&C after the vacuum aspiration. Participants could be terminated by investigators attribute to safety or could voluntarily withdraw from the study for any reason at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the number of women with IUA formation after vacuum aspiration in each group at 8-12 weeks follow-up, comparing between vacuum aspiration alone and vacuum aspiration plus ACH gel application. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome was severity of IUA at 8-12 weeks follow-up, comparing between vacuum aspiration alone and vacuum aspiration plus ACH gel application. Also, postoperative complication and adverse events related to the ACH gel application were recorded. | — |
Countries
Asia(except Japan)
Contacts
Public ContactJidapa Vatanatara
Ramathibodi Hospital, Mahidol University Obstetric and Gynaecology
Outcome results
None listed