Breastfeeding Intervention Study

NCT ID: NCT02016586

Last Updated: 2016-05-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-05-31

Brief Summary

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To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.

Detailed Description

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This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.

Conditions

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Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Control Group

Subjects in the control group will continue to take the prenatal supplement primarily consisting of folic acid (400 mcg), elemental iron (60 mg) and will receive breastfeeding advice during prenatal visits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Lactation support in conjunction with a maternal nutritional supplement S348S0

Group Type EXPERIMENTAL

Maternal Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

S348S0

Interventions

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Maternal Nutritional Supplement

S348S0

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Mother with singleton pregnancy at 26 to 29 weeks of gestation.
2. Mother is between 20 and 35 years of age.
3. Mother pre-pregnant BMI \< 25.0 kg/m2.
4. Mother is first-time mother.
5. Mother is contactable by telephone.
6. Mother is non-smoker.
7. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
8. Infant's birth weight was \> 2500 g.
9. Infant is judged to be in good health.
10. Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.

Exclusion Criteria

1. Mother is allergic or intolerant to any ingredient found in the study product.
2. An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
3. Mother has gestational diabetes and/or pre-eclampsia.
4. Mother with contraindications to breastfeeding.
5. Gestational weight gain is greater than 14 kg at enrollment.
6. Mother had a breast surgery.
7. Mother and/or newborn infant has major illness that requires intensive care admission.
8. Infant has major congenital anomaly.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dieu Huynh, MD, PhD.

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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An Lao District Health Center - Bat Trang

Haiphong, , Vietnam

Site Status

An Lao District Health Center - Quoc Tuan

Haiphong, , Vietnam

Site Status

An Lao District Health Center - Thai Son

Haiphong, , Vietnam

Site Status

An Lao District Health Centre- Quoc Trung

Haiphong, , Vietnam

Site Status

An Lao District Health Centre- Truang Tho

Haiphong, , Vietnam

Site Status

Bin Luc District Health Centre- Dong Du

Hà Nam, , Vietnam

Site Status

Binh Luc District Health Center - An Lao

Hà Nam, , Vietnam

Site Status

Binh Luc District Health Center - Binh Nghia

Hà Nam, , Vietnam

Site Status

Binh Luc District Health Center - Trang An

Hà Nam, , Vietnam

Site Status

Yen Mo District Health Center - Yen Dong

Ninh Bình, , Vietnam

Site Status

Yen Mo District Health Center - Yen Hoa

Ninh Bình, , Vietnam

Site Status

Yen Mo District Health Center - Yen Thanh

Ninh Bình, , Vietnam

Site Status

Phu Binh District Health Center - Kha Son

Thái Nguyên, , Vietnam

Site Status

Phu Binh District Health Center - Tan Khanh

Thái Nguyên, , Vietnam

Site Status

Phu Binh District Health Center - Tan Kim

Thái Nguyên, , Vietnam

Site Status

Phu Binh District Health Centre- Tan Duc

Thái Nguyên, , Vietnam

Site Status

Phu Binh District Health Centre- Tan Hoa

Thái Nguyên, , Vietnam

Site Status

Phu Binh District Health Centre- Xuan Phuong

Thái Nguyên, , Vietnam

Site Status

Countries

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Vietnam

References

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Tran NT, Nguyen LT, Berde Y, Low YL, Tey SL, Huynh DTT. Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):468. doi: 10.1186/s12884-019-2643-6.

Reference Type DERIVED
PMID: 31801514 (View on PubMed)

Other Identifiers

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AL08

Identifier Type: -

Identifier Source: org_study_id

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