UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Placental Transfer of hydroxyethyl starch 130/0.42
Title of the study (Brief title)	PT-HES study
Region	Japan

Condition
Condition	Cesarean section
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Rapid infusion of hydroxyethyl starch (HES) has confirmed the effectiveness of preventing spinal anesthesia induced hypotension during cesarean delivery. Because molecular size of HES is over 1,000 Dalton, HES seems not to transfer from mother to fetus throughout placenta. However, the placental transfer of HES has not corroborated. The purpose of this study is to elucidate the placental transfer of HES from mother to fetus during cesarean section.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Weight distribution of HES in umbilical blood
Key secondary outcomes	Weight distribution of HES in maternal bllod

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	Medicine
Interventions/Control_1	HES 130/0.42
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who are planned cesarean section
Key exclusion criteria	Preeclampsia
Target sample size	6

Research contact person
Name of lead principal investigator	Katsuo TERUI
Organization	Saitama medical center
Division name	Division of obstetric anesthesia
Address	1981 Kamoda Kawagoe Saitama
TEL	049-228-3400
Email	terui@saitama-med.ac.jp

Public contact
Name of contact person	Yusuke MAZDA
Organization	Saitama medical center
Division name	Division of obstetric anesthesia
Address	1981 Kamoda Kawagoe Saitama
TEL	049-228-3400
Homepage URL
Email	mazda@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

Funding Source
Organization	Saitama medical university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	埼玉医科大学総合医療センター産科麻酔科

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 07 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 21 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016335