Women Empowered Through Education to Breastfeed

NCT03481166 | Completed DMC

• 1 other identifier: 111412
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The experience of breastfeeding-related pain is common for postpartum women, but is not often anticipated as part of the postpartum experience. This feasibility randomized controlled trial aims to examine the effectiveness of a nurse-led educational intervention using anticipatory guidance among pregnant women wishing to breastfeed on breastfeeding outcomes, breastfeeding-related pain, and maternal satisfaction.

Conditions

Breastfeeding; Pain; Nipple Pain During Lactation

Keywords

pilot; randomized controlled trial; prenatal education; anticipatory guidance

Outcome Measures

Primary Outcomes (1)

• Breastfeeding duration

  Breastfeeding duration will be measured by asking women if they have breastfed in the past 24 hours or not. If a participant has stopped breastfeeding, they will be asked for the last date they breastfed their infant to determine the number of days (duration) of breastfeeding.

  4 weeks postpartum

Secondary Outcomes (2)

• Breastfeeding exclusivity

  2 and 4 weeks postpartum

• Pain severity

  4 weeks postpartum

Other Outcomes (3)

• maternal satisfaction

  2 and 4 weeks postpartum

• breastfeeding self-efficacy

  2 and 4 weeks postpartum

• women's attitude toward breastfeeding

  2 and 4 weeks postpartum

Study Arms (2)

Education on breastfeeding pain

EXPERIMENTAL

Both the experimental and control groups will receive usual prenatal education offered through our regional public health program. In addition to usual prenatal education, the experimental group will also receive a one-hour, nurse led (a Registered Nurse specially trained in perinatal care), small group-based education session with specific focus on breastfeeding pain. The goals of this educational intervention are to provide pregnant women with anticipatory guidance around pain which is commonly experienced while breastfeeding in the first two weeks postpartum. Education will include the prevalence, etiology and management of various types of breastfeeding-related pain experienced postpartum.

Other: Education on breastfeeding pain

Usual prenatal education

NO INTERVENTION

Women allocated to the usual prenatal education group will receive prenatal classes through their local public health unit. Women enrolled in classes will receive approximately 12 hours of combined in-class and online prenatal content. Topics include: discomforts of pregnancy, labor and birth, medical interventions, adjustment to parenting, breastfeeding, and caring for the newborn. Breastfeeding-related material includes basic mechanisms of milk production, benefits of breastfeeding, benefits of skin-to-skin, correct breastfeeding latch, breastfeeding positions, timing of feeds, responding to infant cues, and caring for nipples. Women in the usual prenatal education group will not receive education on the prevalence and etiology of nipple pain, nor specific pain management strategies.

Interventions

Education on breastfeeding pain OTHER

A Registered Nurse with specialization in antenatal and postpartum care will deliver a one-hour, group-based educational session specifically on breastfeeding-related pain, including: common causes of nipple pain, prevalence of nipple pain, impact of pain on milk ejection reflex, and common approaches to prevention and management of nipple pain.

Education on breastfeeding pain

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who self-enrolled in prenatal education classes at public health unit who:
• Can read and write in English
• Less than or equal to 32 weeks gestation (in pregnancy)
• Planning to breastfeed their infant
• years of age or older
• Internet accessible

You may not qualify if:

• Greater than 32 weeks gestation
• have been identified as having a high-risk pregnancy
• have self-identified barriers to breastfeeding
• have peers or family already enrolled in the study

Sponsors & Collaborators

• Western University, Canada: lead
• Women's College Hospital: collaborator

Study Sites (1)

Middlesex London Health Unit

London, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Feeding; Pain

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimberley T Jackson, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 29, 2018
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)