Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851651
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2023-04-17
Brief Title:
Gestational Diabetes and Antenatal Human Milk Expression
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression GAME Programme in Hong Kong Chinese Women
Status:
COMPLETED
Status Verified Date:
2023-04
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:
Exclusive breastfeeding is global recognized as the optimal infant feeding Hong Kong is committed to promoting protecting and supporting the global movement for successful breastfeeding Exclusive breastfeeding is especially strongly recommended and supported to the maternal history of Gestational Diabetes Mellitus GDM This study aims to examine the acceptability and feasibility of Antenatal human milk expression AME as breastfeeding intervention to improve breastfeeding for GDM women The efficacy of AME practice on the breastfeeding exclusivity will also be investigated It is hypothesized that AME will increase breastfeeding exclusivity compare with women receiving standard care and will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth
Detailed Description:
The incidence of GDM has been increasing worldwide and varied globally Women with previous GDM have a 7-fold higher risk of developing diabetes mellitus over their lifetime It has emerged global public health concern Studies found that women with GDM breastfeed her baby significantly reduce the risk of Type 2 Diabetes and cardiometabolic disease and improve postpartum glucose metabolism However evidence shows that GDM women have breastfeeding challenges and barriers Women with diabetes experience delay in lactogenesis and infant have increased risk hypoglycaemia they require blood monitoring and are often admit to the neonatal unit As a result the infants are more likely to have early receiving of formula supplementation Besides evidence indicated that low maternal confidence increase depressive symptoms and breastfeeding self-efficacy among GDM women Therefore early lactation support was necessary Greater support for GDM women reduces the risks of hypoglycaemia formula supplementation and early weaning It has been proposed that hand expression of breast milk in pregnancy may promote breastfeeding Mothers with diabetes can express colostrum antenatally for use rather than infant formula if necessary
Though Antenatal Milk Expression AME advises women at risk of early lactation problems very limited evidence regarding the safety and efficacy of the practice Also very limited evidence investigated the AME for diabetes women for improving infant outcomes Few studies found that AME increased confidence and contributed to better preparation on breastfeeding but AME on depressive symptoms is under examined
In Hong Kong AME is not widely practice with inconsistent advice It may raise concern on culture diversity regarding conservative culture in Chinese There is lack of local article on the feasibility and acceptability of AME practice for GDM women in Hong Kong Local clinical protocol on the implementation of AME and instructions on the practice is also absent Given cultural differences in breastfeeding motivation and self-regulation as compared with those of oversea countries the motivation of Hong Kong pregnant women engages in antenatal education and receiving social and breastfeeding support may be differ from women in the West Thus it is important to evaluate the efficacy and experience of AME on Hong Kong Chinese to assess cultural acceptability and effectiveness in supporting baby-friendly hospital practice and breastfeeding continuation
Limited qualitative study compares breastfeeding self-efficacy on GDM women and positive impacts of the self-efficacy on breastfeeding prevalence and duration Besides qualitative study on the experiences and perceptions of GDM women on breastfeeding and the experience on the collection and storage of expressed colostrum are very rare
This blocked randomized parallel-armed controlled trial with mixed method study design which integrating with quantitative and qualitative study will be conducted to examine 1 the acceptability and feasibility of AME as breastfeeding intervention to improve breastfeeding for GDM women how and why AME works or does not work using qualitative research 2 to understand the experience and perceptions of antenatal milk expression among the GDM women and 3 to investigate the efficacy of AME practice on the breastfeeding exclusivity The secondary aims are determining whether AME as mediating variables in the effect on the breastfeeding self-efficacy among Hong Kong GDM women in Hong Kong
The study hypotheses are 1 Antenatal human milk expression AME will increase breastfeeding exclusivity on hospital discharge at 4 weeks and 8 weeks postpartum compare women receiving standard care 2 AME will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth
Though Antenatal Milk Expression AME advises women at risk of early lactation problems very limited evidence regarding the safety and efficacy of the practice Also very limited evidence investigated the AME for diabetes women for improving infant outcomes Few studies found that AME increased confidence and contributed to better preparation on breastfeeding but AME on depressive symptoms is under examined
In Hong Kong AME is not widely practice with inconsistent advice It may raise concern on culture diversity regarding conservative culture in Chinese There is lack of local article on the feasibility and acceptability of AME practice for GDM women in Hong Kong Local clinical protocol on the implementation of AME and instructions on the practice is also absent Given cultural differences in breastfeeding motivation and self-regulation as compared with those of oversea countries the motivation of Hong Kong pregnant women engages in antenatal education and receiving social and breastfeeding support may be differ from women in the West Thus it is important to evaluate the efficacy and experience of AME on Hong Kong Chinese to assess cultural acceptability and effectiveness in supporting baby-friendly hospital practice and breastfeeding continuation
Limited qualitative study compares breastfeeding self-efficacy on GDM women and positive impacts of the self-efficacy on breastfeeding prevalence and duration Besides qualitative study on the experiences and perceptions of GDM women on breastfeeding and the experience on the collection and storage of expressed colostrum are very rare
This blocked randomized parallel-armed controlled trial with mixed method study design which integrating with quantitative and qualitative study will be conducted to examine 1 the acceptability and feasibility of AME as breastfeeding intervention to improve breastfeeding for GDM women how and why AME works or does not work using qualitative research 2 to understand the experience and perceptions of antenatal milk expression among the GDM women and 3 to investigate the efficacy of AME practice on the breastfeeding exclusivity The secondary aims are determining whether AME as mediating variables in the effect on the breastfeeding self-efficacy among Hong Kong GDM women in Hong Kong
The study hypotheses are 1 Antenatal human milk expression AME will increase breastfeeding exclusivity on hospital discharge at 4 weeks and 8 weeks postpartum compare women receiving standard care 2 AME will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth
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