UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004165
Receipt number R000005002
Scientific Title Trial of fetoscopic laser surgery for twin amniotic fluid discordance
Date of disclosure of the study information 2010/09/09
Last modified on 2017/09/11 10:59:15

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Basic information

Public title

Trial of fetoscopic laser surgery for twin amniotic fluid discordance

Acronym

Fetoscopic laser surgery for TAFD

Scientific Title

Trial of fetoscopic laser surgery for twin amniotic fluid discordance

Scientific Title:Acronym

Fetoscopic laser surgery for TAFD

Region

Japan


Condition

Condition

Twin Amniotic Fluid Discordance; TAFD

Classification by specialty

Obstetrics and Gynecology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of fetoscopic laser surgery for the monochorionic twin pregnancy with both the discordance of amniotic fluid between the twins and abnormal Doppler findings.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Completion of laser surgery and safety for pregnant women

Key secondary outcomes

Improvement of TAFD at 14 days after surgery, incidence of TTTS at 14 days after surgery, Complications of laser surgery until 14days after laser surgery


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Fetsocopic laser surgery is performed according to the procedure for twin to twin transfusion syndrome.
The anastomoses between the twins are coagulated by laser under fetoscopy through the maternal abdomen. The lactolinger is infused into the amniotic cavity if necessary. The amniotic fluid is aspirated at the end of the surgery.

Interventions/Control_2


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

16 years-old <=

Age-upper limit

45 years-old >

Gender

Female

Key inclusion criteria

1) Between 20 weeks and 24 weeks 6 days gestation
2) Monochorionic diamniotic twin pregnancy
3) Ultrasound findings within four days before surgery meet the criteria as following
a) not TTTS (Maximal vertical pocket (MVP) between 2cm and 8cm)
b) MVP blow 3cm in one twin, and MVP more than 7cm in the other twin
c) Presence of abnormal Doppler study in either twin
4) No history of amnioreduction
5) No presence of fetal anomalies
6) No sign of pregnancy induced hypertension
7) No genital bleeding
8) No premature rupture of membrane
9) Cervical length more than 20mm

Key exclusion criteria

1) Distance between expected insertion site of fetoscopy and the edge of placenta is below 1 cm.
2) Pregnant woman needs treatment for infectious disease.
3) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women
4) Pregnant woman needs treatment for psychological problems
5) American Society of Anesthesiology (ASA) Physical Status Classification: Class 3, 4, 5, or 6

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Sago MD PhD

Organization

National Center for Child Health and Development

Division name

Department of Maternal-Fetal and Neonatal Medicine

Zip code


Address

2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Email

sagou-h@ncchd.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhiko Sago MD PhD

Organization

National Center for Child Health and Development

Division name

Division of Fetal Medicine, Department of Maternal-Fetal and Neonatal Medicine

Zip code


Address

2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Homepage URL


Email

sagou-h@ncchd.go.jp


Sponsor or person

Institute

Japan Fetal Therapy Group (Fetusjapan)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2010 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A total of 11 cases were enrolled.
FLP was completed in all cases.
There were no severe FLP-related maternal complications.
Among 11 donor twins, 3 survived, 7 died in utero, and 1 died in the neonatal period (survival rate: 27.3%).
All of the recipient twins survived (survival rate: 100%).

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

Completed

Date of protocol fixation

2010 Year 04 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2014 Year 10 Month 06 Day

Date of closure to data entry

2014 Year 10 Month 06 Day

Date trial data considered complete

2014 Year 10 Month 14 Day

Date analysis concluded

2016 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 06 Day

Last modified on

2017 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name