An interventional study of Education on breastfeeding pain in Breastfeeding, Pain and Nipple Pain During Lactation, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to female participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Western University, Canada · Not applicable, Interventional, and Prevention
Among 33 studies in Breast Feeding with a site in Canada — 4 open to participants now, 8 under way, none of them phase 3. Breast Feeding · Canada.
Among the 33 studies in Breast Feeding with a site in Canada, this one is the 20th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2019, is one of 14 with no phase, and was the 18th registered.
1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.
Browse Breast Feeding studies →4 of the 33 studies in Breast Feeding with a site in Canada are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Canada, United States, Denmark and 4 more countries
Ages 3 wk+ · Women only
University of Saskatchewan · Sites in Canada
Ages 15+
Duke University · Sites in Canada, United States
Warsaw University of Life Sciences · Sites in Canada, Poland
Ages 19+ · Women only · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 19 Years and older · female · healthy volunteers too.
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33 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 100 across 845 interventional studies indexed under Breast Feeding.
Median enrollment 75 across the 22 interventional studies, 203 across the 11 observational. Of the 24 that completed or were terminated, 2 (8%) have results posted.
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2 of 33 have an industry lead sponsor. The 10 most frequent:
Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
Western University, Canada has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
2 of the studies in Breast Feeding with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04992104The Hospital for Sick ChildrenMicrobiome and Malnutrition in Pregnancy | 2027-03 |
| NCT03511118Duke UniversityPharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants | 2027-07-23 |
Add all 2 to your calendar (.ics) → With an account.
Among the 33 studies in Breast Feeding with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women who self-enrolled in prenatal education classes at public health unit who:
Exclusion Criteria:
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
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.
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.
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.
Time frame: 4 weeks postpartum
Breastfeeding exclusivity
Breastfeeding exclusivity is defined as the receipt of breast milk only with no additional food or liquid, including water. Breastfeeding exclusivity will be categorized according to the World Health Organization Infant and Young Child Feeding guidelines (2009) with the following categories: exclusive breastfeeding, predominant, complimentary feeding, breastfeeding or bottle-feeding. Among the extant breastfeeding literature, this is the most commonly utilized means to measure breastfeeding exclusivity.
Time frame: 2 and 4 weeks postpartum
Pain severity
Pain severity will be measured using an 11-point numeric rating scale, where zero represents no pain, and 10 represents the worst pain imaginable.
Time frame: 4 weeks postpartum
maternal satisfaction
Women's self-report of satisfaction with the education they received will be measured by asking women: "were you satisfied receiving additional breastfeeding education", "how effective was the breastfeeding education session in helping you to breastfeed your baby", "how effective was the additional breastfeeding education session in helping you to anticipate the possibility of breastfeeding pain". Responses will include descriptions on a 5 point Likert scale. For example, "1" for "very satisfied", and "5 for "very dissatisfied". There are no reliable, validated measurement tools measuring maternal satisfaction in this context.
Time frame: 2 and 4 weeks postpartum
breastfeeding self-efficacy
Self reported maternal breastfeeding self-efficacy will be measured using the Breastfeeding self-efficacy scale short form (Dennis, 2003. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs, 32(6), 734-44)
Time frame: 2 and 4 weeks postpartum
women's attitude toward breastfeeding
Self reported maternal attitude toward breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (De la Mora et al., 1999. The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology, 29(11), 2362-2380)
Time frame: 2 and 4 weeks postpartum
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Dec 2020, 17 months.
Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 17 months is above that.
Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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