Breastfeeding Clinical Trial
Official title:
The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
NCT number | NCT05066438 |
Other study ID # | Bio 2238 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2021 |
Est. completion date | April 2023 |
Despite recommendations by several health authorities, the rate of sustained exclusive breastfeeding for two months is less than fifty-five percent in Canada. The two most common reasons for early discontinuation are problems with milk supply and difficulty with technique. Antenatal hand expression (AHE) is a method used to assist with colostrum collection in low-risk pregnancies near term. This method has been shown to have several benefits, including increased milk supply at birth. This study aims to determine if the employment of antenatal hand expression in low-risk pregnancies near term affects the rate of sustained breastfeeding exclusively to two months.
Status | Not yet recruiting |
Enrollment | 176 |
Est. completion date | April 2023 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - inclusion to breastfeed - no contraindications to vaginal delivery - multiple gestation only if cleared for vaginal delivery Exclusion Criteria: - intention to formula feed - antenatal hand expression training provided by staff outside of study protocol - practiced antenatal hand expression prior to 36 weeks gestation - breech presentation - history of preterm labour, preterm birth or threatened preterm labour - history of (or current) cervical insufficiency - any contraindication to vaginal delivery (ie. placenta or vasa previa, classical uterine scar, etc.) - intrauterine growth restriction - antepartum hemorrhage - any contraindication to breastfeeding (eg. HIV) - multiple gestation requiring Cesarean delivery |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exclusive breastfeeding to two months | Participant-reported data on newborn dietary intake, collected by telephone questionnaire | This metric measured by questionnaire at two months |
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