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

NCT07128433 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-08-19

No results posted yet for this study

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

Interventions

PROCEDURE

milk expression

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).

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2027-08-18
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128433 on ClinicalTrials.gov