UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of labor analgesia on the prevalence of postpartum depression
Title of the study (Brief title)	Labor analgesia and postpartum depression
Region	Japan

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

Objectives
Narrative objectives1	To identify whether postpartum depression is reduced in women who have experienced labor analgesia during delivery.
Basic objectives2	Others
Basic objectives -Others	To identify the correlation with labor analgesia and labor pain and labor satifaction.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify whether postpartum depression is reduced in women who have received labor analgesia during delivery by analyzing Edinburgh Postnatal Depression Scale scores before and after delivery.
Key secondary outcomes	To identify the impacts of labor analgesia on postpartum pain and labor satisfaction

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women over 35 weeks due who are planned to go through delivery at St. Luke's International Hospital
Key exclusion criteria	1.Cannot fill out the questionnaire due to mental or linguistic disability 2.Is known of a mental disease 3.Is known of fetal disorder
Target sample size	250

Research contact person
Name of lead principal investigator	Yasuko Nagasaka
Organization	St.Luke's International Hospital
Division name	Department of Anesthesia
Address	9-1 Akashi-cho, Chuo-ku Tokyo
TEL	03-3541-5151
Email	nagasaka@luke.ac.jp

Public contact
Name of contact person	Yasuko Nagasaka
Organization	St. Luke's International Hospital
Division name	Department of Anesthesia
Address	9-1 Akashi-cho, Chuo-ku Tokyo
TEL	03-3541-5151
Homepage URL
Email	nagasaka@luke.ac.jp

Sponsor
Institute	St.Luke's International Hospital
Institute
Department

Funding Source
Organization	St. Luke's International University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 17 Day
Anticipated trial start date	2017 Year 12 Month 19 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	N/A

Management information
Registered date	2018 Year 03 Month 31 Day
Last modified on	2018 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036546