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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • milk expression

    Procedure/Surgery

    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).

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Antepartum Milk Expression GroupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Exclusive breastfeeding rates at 3 months postpartum

Time frame
3 months postpartum

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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