Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800509
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-05
First Post:
2023-02-07
Brief Title:
Gestational Diabetes and Perinatal Depression an Intervention Program
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Gestational Diabetes and Depression in Pregnancy and the Postpartum Period Among Primipara Women A Longitudinal Study and Interventive Program
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence which is bidirectional relationship However there are still no any confirmations of relationship in the perinatal period The reason could be that these kinds of studies mostly had been done for postpartum depression they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression Additionally there have not been so many Asian countries which been done this kind of studies therefore this study will focus on the relationship of primiparous gestational diabetes mellitus and perinatal depression
Purpose This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression In the other words the prenatal depression influences on gestational diabetes mellitus and vice versa Those changeable factors such as social support health behavior prenatal body index weight gain during pregnancy perinatal complicationsetc will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depressionAfterwards a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior then depression and other obstetrics and gynecological results will be tested for effects
Purpose This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression In the other words the prenatal depression influences on gestational diabetes mellitus and vice versa Those changeable factors such as social support health behavior prenatal body index weight gain during pregnancy perinatal complicationsetc will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depressionAfterwards a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior then depression and other obstetrics and gynecological results will be tested for effects
Detailed Description:
Background The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence which is bidirectional relationship However there are still no any confirmations of relationship in the perinatal period The reason could be that these kinds of studies mostly had been done for postpartum depression they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression Additionally there have not been so many Asian countries which been done this kind of studies therefore this study will focus on the relationship of primiparous gestational diabetes mellitus and perinatal depression
Purpose This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression In the other words the prenatal depression influences on gestational diabetes mellitus and vice versa Those changeable factors such as social support health behavior prenatal body index weight gain during pregnancy perinatal complicationsetc will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression Afterwards a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior then depression and other obstetrics and gynecological results will be tested for effects
Method The researchers will explain the purpose procedure and informed-consent of this study then informed-consent form will be signed and the structured questionnaire at 22nd week of pregnancy including basic information age level of education and occupation of the participant and her partner household income and status of marriage marriage satisfaction obstetrics and gynecological history history of abortion intended pregnancy and artificial insemination psychiatric history family history of diabetes mellitus height pre-pregnancy weight sleeping status and basic knowledge of gestational diabetes mellitus will be given to fill out The participants will be needed to record the value and date and time of blood sugar and the picture of meals and snacks After the first questionnaire is received from participants and their partners a website of health education of gestational diabetes mellitus with several short clips of health education maternity managementcounseling healthy lifestyles partner supportetc for participants and their partners of experimental group will be given However the participants and their partner of controlled group only receive a website of health education of gestational diabetes mellitus without any clips of health education Afterward structured questionnaire will be also given to the participants and their partners at 35th week of pregnancy 3rd month and 6th months after delivery
Purpose This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression In the other words the prenatal depression influences on gestational diabetes mellitus and vice versa Those changeable factors such as social support health behavior prenatal body index weight gain during pregnancy perinatal complicationsetc will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression Afterwards a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior then depression and other obstetrics and gynecological results will be tested for effects
Method The researchers will explain the purpose procedure and informed-consent of this study then informed-consent form will be signed and the structured questionnaire at 22nd week of pregnancy including basic information age level of education and occupation of the participant and her partner household income and status of marriage marriage satisfaction obstetrics and gynecological history history of abortion intended pregnancy and artificial insemination psychiatric history family history of diabetes mellitus height pre-pregnancy weight sleeping status and basic knowledge of gestational diabetes mellitus will be given to fill out The participants will be needed to record the value and date and time of blood sugar and the picture of meals and snacks After the first questionnaire is received from participants and their partners a website of health education of gestational diabetes mellitus with several short clips of health education maternity managementcounseling healthy lifestyles partner supportetc for participants and their partners of experimental group will be given However the participants and their partner of controlled group only receive a website of health education of gestational diabetes mellitus without any clips of health education Afterward structured questionnaire will be also given to the participants and their partners at 35th week of pregnancy 3rd month and 6th months after delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None