임상연구정보서비스

Search: Search

Can the supplementation of ferric carboxymaltose improve Postpartum depression after delivery?

Status Approved

First Submitted Date

2020/12/07
Registered Date

2020/12/24
Last Updated Date

2024/01/24

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005698
Unique Protocol ID	SCHUH 2020-10-026-002
Public/Brief Title	Can the supplementation of intravenous iron improve Postpartum depression after delivery ?
Scientific Title	Can the supplementation of ferric carboxymaltose improve Postpartum depression after delivery?
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SCHUH 2020-10-026-002
Approval Date	2020-12-04
Institutional Review Board Name	SoonChunHyang University Hospital Seoul Institutional Review Board(IRB)
Institutional Review Board Address	59, Daesagwan-ro, Yongsan-gu, Seoul
Institutional Review Board Telephone	02-709-9750
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	JungJae Lee
Title	MD., PhD.
Telephone	+82-2-709-9320
Affiliation	Soon Chun Hyang University Hospital Seoul
Address	59, Daesagwan-ro, Youngsan-gu, Seoul, Korea, 04401
Contact Person for Public Queries
Name	Jeong-Won Oh
Title	MD.,
Telephone	+82-2-709-9320
Affiliation	Soon Chun Hyang University Hospital Seoul
Address	59, Daesagwan-ro, Youngsan-gu, Seoul, Korea, 04401
Contact Person for Updating Information
Name	Jin A Lim
Title	CRC
Telephone	+82-2-709-9320
Affiliation	Soon Chun Hyang University Hospital Seoul
Address	59, Daesagwan-ro, Youngsan-gu, Seoul, Korea, 04401

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Completed
Date of First Enrollment	2021-02-01 Actual
Target Number of Participant	96
Primary Completion Date	2023-11-01 , Actual
Study Completion Date	2023-12-31 , Actual
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-03-01 ,
Recruitment Status by Participating Study Site 2
Name of Study	Koera University Guro Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-04-01 ,
Recruitment Status by Participating Study Site 3
Name of Study	Soon Chun Hyang University Hospital Seoul
Recruitment Status	Completed
Date of First Enrollment	2021-02-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	JW Pharmaceutical
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Soon Chun Hyang University Hospital Seoul
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Postpartum depression occurs between four and six weeks after childbirth, which causes guilty feelings for mothers or neonates and psychological pressure on parenting threatens their quality of life (QOL) and sometimes it causes life-threatening events. In Korea, few studies have reported that the prevalence of postpartum depression is 3.4%~42.5% respectively. Known major risk factors are depression or anxiety during pregnancy, experiencing stressful life events during pregnancy or the early postpartum period, preterm birth or infant admission to neonatal ICU, low level of social support, previous history of depression, and breastfeeding problems. It is thought to be the sudden postpartum changes in hormones and the environment cause postpartum depression but the definite pathophysiology is unclear. Several studies have shown that postpartum iron deficiency anemia (IDA) affects postpartum depression. In comparison with the anemia during pregnancy, the studies on postpartum anemia and its correction are yet the unexplored fields. Still, there are no major randomized trials to guide screening or management for IDA or to guide iron administration postpartum. The purpose of this study is to provide evidence about the benefits of correcting postpartum IDA by supplementing ferric carboxymaltose, especially in the aspect of preventing and improve postpartum depression and improve maternal fatigue. In this trial, we are planning to give intravenous ferric carboxymaltose 1000-1500mg in women who have postpartum anemia after delivery (case group) and compare the maternal depression mood with the control group with Edinburgh Postnatal Depression Scale (EPDS) questionnaire via social networking service (SNS). Moreover, hematological changes (Hb, ferritin, transferrin saturation) and fatigue scale are going to be compared.

Study Summary Information

Lay Summary

Postpartum depression occurs between four and six weeks after childbirth, which causes guilty feelings for mothers or neonates and psychological pressure on parenting threatens their quality of life (QOL) and sometimes it causes life-threatening events. 
In Korea, few studies have reported that the prevalence of postpartum depression is 3.4&#37;~42.5&#37; respectively. Known major risk factors are depression or anxiety during pregnancy, experiencing stressful life events during pregnancy or the early postpartum period, preterm birth or infant admission to neonatal ICU, low level of social support, previous history of depression, and breastfeeding problems. It is thought to be the sudden postpartum changes in hormones and the environment cause postpartum depression but the definite pathophysiology is unclear. 
Several studies have shown that postpartum iron deficiency anemia (IDA) affects postpartum depression. In comparison with the anemia during pregnancy, the studies on postpartum anemia and its correction are yet the unexplored fields. Still, there are no major randomized trials to guide screening or management for IDA or to guide iron administration postpartum. 
The purpose of this study is to provide evidence about the benefits of correcting postpartum IDA by supplementing ferric carboxymaltose, especially in the aspect of preventing and improve postpartum depression and improve maternal fatigue.
In this trial, we are planning to give intravenous ferric carboxymaltose 1000-1500mg in women who have postpartum anemia after delivery (case group) and compare the maternal depression mood with the control group with Edinburgh Postnatal Depression Scale (EPDS) questionnaire via social networking service (SNS). Moreover, hematological changes (Hb, ferritin, transferrin saturation) and fatigue scale are going to be compared.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Factorial
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	In this trial, we are planning to give intravenous ferric carboxymaltose 1000-1500mg in women who have postpartum anemia after delivery (case group) and compare the maternal depression mood with the control group with Edinburgh Postnatal Depression Scale (EPDS) questionnaire via social networking service (SNS). Also hematological changes (Hb, ferritin, transferrin saturation) and shortened 10 item fatigue scale are going to be compared.
Number of Arms	2
Arm 1	Arm Label study group
	Target Number of Participant 48
	Arm Type Experimental
	Arm Description . The study group would be treated with intravenous ferric carboxymaltose 1000mg on postpartum day 1-3 of term delivery (If 1500mg needed, 500mg will be administered the week after, the first follow up visit).
Arm 2	Arm Label control group
	Target Number of Participant 48
	Arm Type Active comparator
	Arm Description The control group would be treated with the standard of care for postpartum anemia.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (O00-O99)Pregnancy, childbirth and the puerperium (O99.0)Anaemia complicating pregnancy, childbirth and the puerperium Pregnancy, normal spontaneous vaginal delivery, Cesarean section, term delivery, postpartum depression, postpartum anemia
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~45Year
	Description 1. 19 to 45 years old of postpartum women who have IDA after term delivery (regardless of delivery mode [i.e., elective Cesarean section, normal vaginal delivery, emergency Cesarean section]) and 2. Hb level is 8 g/dL or more and less than 11 g/dL on PP 1~3 days and 3. EPDS score to ≥ 8 on PP 1~3 day 4. Ferritin level is less than 30 ng/ml or transferrin saturation is less than 20% on PP 1~3 days.
Exclusion Criteria	① Postpartum women who had ever had an intravenous injection of iron in the past 3 months. ② Postpartum women whose Hb level on 3rd postpartum day is less than 8g/dL ③ Previous experience of adverse events with intravenous iron injection. ④ A previously diagnosed woman with mood disorder includes pre-existing depression ⑤ Patients with researchers has been determined to be not appropriate to participate
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Evaluation of maternal depression mood with EPDS questionnaire at 8 weeks of post delivery, EPDS score Change from baseline to 8 weeks
Timepoint	1) at 8 weeks of post delivery; 2) from 1~3 days of delivery to 8 weeks
Secondary Outcome(s) 1
Outcome	the measured depression rate on postpartum 8 weeks in EPDS score to <8
Timepoint	at 8 weeks of post delivery
Secondary Outcome(s) 2
Outcome	Change of Fatigue score and EPDS score
Timepoint	at postpartum 1~3 days, 10 days, 4weeks, 6weeks and PP 8 weeks
Secondary Outcome(s) 3
Outcome	Hb, ferritin, transferrin saturation
Timepoint	from 1~3 days of delivery to 8 weeks
Secondary Outcome(s) 4
Outcome	Adverse events after IV ferric carboxymaltose 1000mg
Timepoint	from 1~3 days of delivery to 8 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top