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

NCT ID: NCT07128433

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestatiaonl Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Antepartum Milk Expression Group

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

Group Type ACTIVE_COMPARATOR

milk expression

Intervention Type 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).

Control group

Participants will receive routine antenatal care and standard postpartum management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ye Feng, M.D.

Role: CONTACT

8618001203634

Other Identifiers

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2025R0084-0001

Identifier Type: -

Identifier Source: org_study_id

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