Unique ID issued by UMIN | UMIN000041898 |
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Receipt number | R000047822 |
Scientific Title | Use of Alginate Carboxymethylcellulose Hyaluronic Acid for Prevention of Intrauterine Adhesion after Vacuum Aspiration in Patients with First Trimester Abortion: A Prospective Randomized controlled trial |
Date of disclosure of the study information | 2020/09/25 |
Last modified on | 2020/09/25 23:12:32 |
Use of Alginate Carboxymethylcellulose Hyaluronic Acid for Prevention of Intrauterine Adhesion after Vacuum Aspiration in Patients with First Trimester Abortion: A Prospective Randomized controlled trial
Use of Alginate Carboxymethylcellulose Hyaluronic Acid for Prevention of Intrauterine Adhesion after Vacuum Aspiration in Patients with First Trimester Abortion: A Prospective Randomized controlled trial
Use of Alginate Carboxymethylcellulose Hyaluronic Acid for Prevention of Intrauterine Adhesion after Vacuum Aspiration in Patients with First Trimester Abortion: A Prospective Randomized controlled trial
Use of Alginate Carboxymethylcellulose Hyaluronic Acid for Prevention of Intrauterine Adhesion after Vacuum Aspiration in Patients with First Trimester Abortion: A Prospective Randomized controlled trial
Asia(except Japan) |
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
Obstetrics and Gynecology |
Others
NO
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
Safety,Efficacy
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.
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.
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
No treatment
2
Prevention
Medicine |
Intervention: Alginate carboxymethylcellulose hyaluronic acid gel
Control: no treatment
15 | years-old | <= |
50 | years-old | >= |
Female
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.
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.
68
1st name | Jidapa |
Middle name | |
Last name | Vatanatara |
Ramathibodi Hospital, Mahidol University
Obstetric and Gynaecology
10400
270 Rama VI Road
+66891267037
oummy.jidapa.v@gmail.com
1st name | Jidapa |
Middle name | |
Last name | Vatanatara |
Ramathibodi Hospital, Mahidol University
Obstetric and Gynaecology
10400
270 Rama VI Rd. Phayatai Ratchathewi Bangkok
+66891267037
oummy.jidapa.v@gmail.com
Ramathibodi Hospital, Mahidol University
Ramathibodi Hospital, Mahidol University
Other
Faculty of Medicine Ramathibodi Hospital, Mahidol University
270 Rama VI Rd. Phayatai Ratchathewi Bangkok 10400
+6602012175
raec.mahidol@gmail.com
NO
2020 | Year | 09 | Month | 25 | Day |
Unpublished
68
No longer recruiting
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 08 | Month | 16 | Day |
2019 | Year | 09 | Month | 01 | Day |
2020 | Year | 07 | Month | 15 | Day |
2020 | Year | 09 | Month | 25 | Day |
2020 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047822
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