UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041898
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

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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

Obstetrics 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 or person

Institute

Ramathibodi Hospital, Mahidol University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name