Gestational Diabetes and Antenatal Human Milk Expression

NCT05851651 | Completed

• 1 other identifier: GAME
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 2

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Infant Feeding pattern

  Exclusive breastfeeding prevalence

  At 4 weeks postpartum

• Infant Feeding pattern

  Exclusive breastfeeding prevalence

  At 8 weeks postpartum

Secondary Outcomes (4)

• Women's self-determination toward breastfeeding

  At baseline, 4 weeks and 8 weeks postpartum

• Women's self-efficacy in breastfeeding

  At baseline, 4 weeks and 8 weeks postpartum

• Women's perinatal/postnatal depression

  At baseline, 4 weeks and 8 weeks postpartum

• Women's prevalence of Impaired Glucose Tolerance

  At 6 weeks postpartum

Other Outcomes (1)

• Women's experience, perception, and attitude for AME practices

  At 6 weeks postpartum

Study Arms (2)

Standard care plus an antenatal milk expression education

EXPERIMENTAL

Participants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery.

Behavioral: Antenatal milk expression and breastfeeding self-efficacy enhancement

Standard hospital antenatal care

NO INTERVENTION

Participants will receive standard care include prenatal breastfeeding education at gestation of 24-36 weeks same as intervention group. They will not discuss about antenatal milk expression, breastfeeding self-efficacy and the effects of breastfeeding on GDM women.

Interventions

Antenatal milk expression and breastfeeding self-efficacy enhancement BEHAVIORAL

A face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation will be arranged. The session will approximately last for 45minutes. GDM leaflet and GAME fact sheet are used to facilitate the teaching. The benefits of breastfeeding for women with GDM will be addressed. Maternal metabolic control, calories consumed, and weight loss are addressed for the extra benefits of breastfeeding for GDM women. The possible challenges of GDM on breastfeeding will be supported. The antenatal human milk expression will be taught by International Board-Certified Lactation Consultant. Participants will be encouraged to express colostrum twice daily for up to 10 minutes until admitted to hospital to give birth. They will receive a weekly phone follows up from 38 weeks before delivery and they can contact the researcher by phone in the information sheet if any questions.

Standard care plus an antenatal milk expression education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed gestational diabetes without on insulin
• can read and speak Chinese
• Hong Kong resident and stay in Hong Kong after delivery
• no serious medical or obstetrical complications
• no mental health illness or history
• have regular antenatal check-up
• singleton pregnancy
• primiparous or multiparous women
• intention to breastfeed
• pre-pregnancy BMI\<25

You may not qualify if:

• do not have Hong Kong Identify Card
• breastfeeding elder child at pregnancy
• cannot understand the study
• give birth \<37 weeks of gestation
• a known fetal anomaly or any suspicion of fetal compromise

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Yu Ngai Ms Leung, MPH

  Department of Obstetrics and Gynaecology, Kwong Wah Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 10, 2023
• Study Start: May 10, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)