NCT02016586

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

November 29, 2013

Last Update Submit

May 23, 2016

Conditions

Breast Feeding

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Rate

    Week 12 postpartum

Secondary Outcomes (8)

  • Breastfeeding Rate

    Week 4 postpartum

  • Lactation Assessment

    Week 4 postpartum

  • Infant Anthropometrics

    Week 4 postpartum

  • Breastfeeding Rate

    Week 8 postpartum

  • Lactation Assessment

    Week 8 postpartum

  • +3 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

Lactation support in conjunction with a maternal nutritional supplement S348S0

Dietary Supplement: Maternal Nutritional Supplement

Interventions

Maternal Nutritional SupplementDIETARY_SUPPLEMENT

S348S0

Intervention

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

An Lao District Health Center - Bat Trang

Haiphong, Vietnam

Location

An Lao District Health Center - Quoc Tuan

Haiphong, Vietnam

Location

An Lao District Health Center - Thai Son

Haiphong, Vietnam

Location

An Lao District Health Centre- Quoc Trung

Haiphong, Vietnam

Location

An Lao District Health Centre- Truang Tho

Haiphong, Vietnam

Location

Bin Luc District Health Centre- Dong Du

Hà Nam, Vietnam

Location

Binh Luc District Health Center - An Lao

Hà Nam, Vietnam

Location

Binh Luc District Health Center - Binh Nghia

Hà Nam, Vietnam

Location

Binh Luc District Health Center - Trang An

Hà Nam, Vietnam

Location

Yen Mo District Health Center - Yen Dong

Ninh Bình, Vietnam

Location

Yen Mo District Health Center - Yen Hoa

Ninh Bình, Vietnam

Location

Yen Mo District Health Center - Yen Thanh

Ninh Bình, Vietnam

Location

Phu Binh District Health Center - Kha Son

Thái Nguyên, Vietnam

Location

Phu Binh District Health Center - Tan Khanh

Thái Nguyên, Vietnam

Location

Phu Binh District Health Center - Tan Kim

Thái Nguyên, Vietnam

Location

Phu Binh District Health Centre- Tan Duc

Thái Nguyên, Vietnam

Location

Phu Binh District Health Centre- Tan Hoa

Thái Nguyên, Vietnam

Location

Phu Binh District Health Centre- Xuan Phuong

Thái Nguyên, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 31801514DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Dieu Huynh, MD, PhD.

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 20, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

VN(18)