Impact of Antepartum Breast Milk Expression on Breastfeeding Rates in Patients With Gestational Diabetes Mellitus

NCT07128433 | Not Yet Recruiting DMC

• 1 other identifier: 2025R0084-0001
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study proposes a prospective randomized controlled clinical trial involving primiparous women diagnosed with gestational diabetes mellitus (GDM) carrying singleton pregnancies. Participants will be randomized in a 1:1 ratio into either a control group or an intervention group. The control group will receive standard prenatal care followed by routine postpartum breastfeeding guidance. In addition to the standard care provided to the control group, the intervention group will receive one-on-one midwife-led manual breast milk expression training at the breastfeeding clinic. They will begin manual expression twice daily starting at 37 weeks gestation. The primary outcome will compare exclusive breastfeeding rates at 3 months postpartum between groups through postpartum follow-up assessments to evaluate the impact of antenatal milk expression on breastfeeding success in GDM patients.

Conditions

Gestatiaonl Diabetes Mellitus

Keywords

Antepartum; milk expression; Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding rates at 3 months postpartum

  3 months postpartum

Study Arms (2)

Antepartum Milk Expression Group

ACTIVE COMPARATOR

Oarticipants will receive one-on-one antenatal breast milk expression instruction by a midwife and initiate twice-daily practice from 37 weeks gestation onward.

Procedure: milk expression

Control group

NO INTERVENTION

Participants will receive routine antenatal care and standard postpartum management

Interventions

milk expression PROCEDURE

Following one-on-one antenatal manual colostrum expression instruction by a midwife at the breastfeeding clinic, participants will initiate twice-daily practice from 37 weeks gestation onward, performing 3-5 minutes of manual expression per breast per session (total duration ≤10 minutes per session).

Antepartum Milk Expression Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Biologically female individuals capable of conception and childbirth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Expressed intention for exclusive breastfeeding; Aged 20-45 years; Nulliparous status; Singleton pregnancy; GDM diagnosed per 75g OGTT at 24-28 weeks

You may not qualify if:

• Contraindications to breastfeeding; multifetal pregnancy; placenta previa; pregestational diabetes mellitus; preeclampsia; contraindications to vaginal delivery; fetal structural anomalies (cleft lip/palate, cardiac malformations, neural tube defects); chromosomal abnormalities or metabolic disorders affecting suckling ability (e.g., phenylketonuria); intrauterine growth restriction; macrosomia; polyhydramnios; maternal psychiatric disorders (depression or anxiety disorders)

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ye Feng, M.D.

CONTACT

8618001203634; fengye_bjmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): August 18, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08