UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	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
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
Scientific Title:Acronym	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
Region	Asia(except Japan)

Condition
Condition	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
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Intervention: Alginate carboxymethylcellulose hyaluronic acid gel
Interventions/Control_2	Control: no treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key 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.
Key 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.
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Jidapa Middle name Last name Vatanatara
Organization	Ramathibodi Hospital, Mahidol University
Division name	Obstetric and Gynaecology
Zip code	10400
Address	270 Rama VI Road
TEL	+66891267037
Email	oummy.jidapa.v@gmail.com

Public contact
Name of contact person	1st name Jidapa Middle name Last name Vatanatara
Organization	Ramathibodi Hospital, Mahidol University
Division name	Obstetric and Gynaecology
Zip code	10400
Address	270 Rama VI Rd. Phayatai Ratchathewi Bangkok
TEL	+66891267037
Homepage URL
Email	oummy.jidapa.v@gmail.com

Sponsor
Institute	Ramathibodi Hospital, Mahidol University
Institute
Department

Funding Source
Organization	Ramathibodi Hospital, Mahidol University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Medicine Ramathibodi Hospital, Mahidol University
Address	270 Rama VI Rd. Phayatai Ratchathewi Bangkok 10400
Tel	+6602012175
Email	raec.mahidol@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	68
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2020 Year 07 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 25 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047822