UMIN-CTR Clinical Trial

Public title

Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction

Acronym

Fetoscopic laser surgery for SIUGR

Scientific Title

Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction

Scientific Title:Acronym

Fetoscopic laser surgery for SIUGR

Region

Japan

Condition

Monochorionic twin pregnancy with severe selective intarauterine growth restriction; SIUGR

Classification by specialty

Obstetrics and Gynecology

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of fetoscopic laser surgery for the monochorionic twin pregnancy with severe selective intarauterine growth restriction.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Completion of laser surgery and safety for pregnant women

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

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

Age-lower limit

16

years-old

<=

Age-upper limit

45

years-old

>

Gender

Female

Key inclusion criteria

1) Between 20 weeks and 24 weeks gestation
2) Monochorionic diamniotic twin pregnancy
3) Ultrasound findings within four days before surgery meet the criteria as described following
I) Estimated fetal weight is less than -1.5SD in one twin
II) not TTTS (MVP>2cm in one twin, and MVP<8cm in another twin and not TAFD(MVP<3cm in one twin and MVP>7cm in another twin)
III) The presence of severe oligohydramnios defined by less than 1cm of MVP in a smaller twin
IV) Presence of abnormal Doppler study in a smaller 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) Greater than or equal to 20mm of Cervical length

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

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

813334160181

Email

sagou-h@ncchd.go.jp

Name of contact person

1st name
Middle name
Last name	Keisuke Ishii MD Ph D

Organization

Osaka Medical Center and Research Institute for Maternal and Child Health

Division name

Department of Maternal-Fetal Medicine

Zip code

Address

840 Murodo, Izumi, Osaka, 5941101, Japan

TEL

81725561220

Homepage URL

Email

keisui@mch.pref.osaka.jp

Institute

Japan Fetal Therapy Group (Fetus Japan)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立成育医療研究センター（東京都）、聖隷浜松病院（静岡県）、国立病院機構長良医療センター（岐阜県）、大阪府立母子保健総合医療センター（大阪府）、徳山中央病院（山口県）

Date of disclosure of the study information

2012

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2014

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

01

Month

01

Day

Last modified on

2015

Year

01

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008260