Clinical trial NCT03481166: Women Empowered Through Education to Breastfeed
Official title: Empowering Women to Cope with Breastfeeding Pain: a Feasibility Randomized Controlled Trial of an Educational Anticipatory Guidance Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Pain
Nipple Pain During Lactation
Keywords: pilot
randomized controlled trial
prenatal education
anticipatory guidance
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Women's College Hospital
First posted: 2018-03-29
Enrollment: 13
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Despite the relative ubiquity of breastfeeding-related pain, exploratory studies suggest women are largely unprepared for breastfeeding-related pain in the early postpartum period \[1-3\]. In turn, postpartum women often experience an incongruence between how breastfeeding is idealized by Western society, and the reality of their early breastfeeding experiences. Furthermore, painful breastfeeding experiences serve to intensify this incongruity and may lead to disillusionment, feelings of negative self-worth and premature breastfeeding cessation \[1,3\]. As such, the overarching goals of this one-year project are to compare usual prenatal education to anticipatory guidance to: 1) examine the effectiveness of a breastfeeding education session using anticipatory guidance on breastfeeding outcomes and satisfaction during the postpartum period; and 2) test the feasibility of the methods and procedures needed for the successful implementation and validity of a full-scale randomized controlled trial (RCT). This one-year project has 5 objectives:

To fill a knowledge gap in nursing and allied health-related literature by examining the effect of a one-hour, nurse-led, breastfeeding education session using anticipatory guidance during pregnancy on: Objective 1: breastfeeding duration and exclusivity versus those receiving usual prenatal education; Objective 2: overall satisfaction with the educational experience versus those receiving usual prenatal education; Objective 3: breastfeeding self-efficacy and infant feeding attitudes; Objective 4: postpartum breastfeeding-related pain and; Objective 5: To determine if this intervention study protocol is practical (e.g., accrual rates, satisfaction, compliance, sample size) and to test the process, resources, management and scientific basis \[4\] for a future, full-scale RCT.

Forty pregnant women enrolled in prenatal classes provided by the Middlesex London Health Unit (MLHU) and who are intending to breastfeed will be enrolled in this feasibility randomized controlled trial.

Following ethics approval, interested pregnant women who have enrolled in/awaiting antenatal classes at the MLHU will contact the RA to discuss the study. Interested women will be screened for eligibility, and if eligible and consenting, baseline data will be collected. Participants will then be randomized to either intervention (n=20) or control group (n=20). Randomization will be achieved by using sealed, opaque, sequentially numbered envelopes containing randomly generated numbers, prepared by an RA external to the study. An RA will open the next sequentially numbered envelope and reveal the group allocation to the participant. The control group will receive usual antenatal education provided to all women who enroll in MLHU prenatal classes. The intervention group will receive an additional one-hour 'booster session' (by a perinatal RN) of antenatal education specifically focused on the postpartum experience of breastfeeding, including anticipatory guidance around breastfeeding-related pain, and management strategies. To control for contamination, women who have peers/family already in the study will be excluded. An emailed link to a follow-up questionnaire will be sent at 2 and 4 weeks postpartum to determine if they are breastfeeding or not, breastfeeding exclusivity, level of breastfeeding-related pain, breastfeeding self-efficacy, maternal attitudes toward infant feeding, and maternal satisfaction with antenatal education.

Eligibility criteria: Inclusion Criteria:

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
* 19 years of age or older
* Internet accessible

Exclusion Criteria:

* 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

Primary outcomes:
measure: Breastfeeding duration
timeFrame: 4 weeks postpartum
Secondary outcomes:
measure: Breastfeeding exclusivity
timeFrame: 2 and 4 weeks postpartum
measure: Pain severity
timeFrame: 4 weeks postpartum
Other outcomes:
measure: maternal satisfaction
timeFrame: 2 and 4 weeks postpartum
measure: breastfeeding self-efficacy
timeFrame: 2 and 4 weeks postpartum
measure: women's attitude toward breastfeeding
timeFrame: 2 and 4 weeks postpartum
Locations:
city: London
country: Canada
facility: Middlesex London Health Unit
state: Ontario
Study officials:
affiliation: Western University
name: Kimberley T Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
References: