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OpenTrials
Completed

NCT Number: NCT02016586

Breastfeeding Intervention Study

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

Completed

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

An Lao District Health Center - Bat Trang, Haiphong, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Maternal Nutritional Supplement

Dietary Supplement

S348S0

Primary outcomes

  1. Breastfeeding Rate

    Time frame: Week 12 postpartum

Secondary outcomes

  1. Breastfeeding Rate

    Time frame: Week 4 postpartum

  2. Lactation Assessment

    Time frame: Week 4 postpartum

    Maternal completed questionnaire with visual analogue scales

  3. Infant Anthropometrics

    Time frame: Week 4 postpartum

    Scale weight; Length and head circumference measurement

  4. Breastfeeding Rate

    Time frame: Week 8 postpartum

  5. Lactation Assessment

    Time frame: Week 8 postpartum

    Maternal completed questionnaire with visual analogue scales

  6. Lactation Assessment

    Time frame: Week 12 postpartum

    Maternal completed questionnaire with visual analogue scales

  7. Infant Anthropometrics

    Time frame: Week 8 postpartum

    Scale weight; Length and head circumference measurement

  8. Infant Anthropometrics

    Time frame: Week 12 postpartum

    Scale weight; Length and head circumference measurement

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 20, 2013
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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