- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220413
Predictors of Lactogenesis II
Predictors and Moderators of Delayed Lactogenesis II and Duration of Breastfeeding
The purpose of this study is to investigate what proportion of obese women will have a self-reported delay in lactogenesis II ("breastmilk coming in") compared to women with a normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed lactogenesis II.
We will compare two group of women for delayed lactogenesis II, one group with obese women (BMI>30) and one group of women with a normal weight (BMI<30).
The secondary objective is to assess what other factors influence the self-reported delayed lactogenesis II.
Study Overview
Status
Conditions
Detailed Description
Lactogenesis I occurs during pregnancy (midpregnancy and beyond), when the mammary glands becomes sufficiently differentiated to secrete small quantities of specific milk components. Lactogenesis II is defined as the onset of plentiful milk secretion and typically occurs between 30-40 hours post delivery. It is typically described by women as a sense of fullness and leakage of milk which is subjectively reported between 50-73 hours post delivery. The incidence of delayed lactogenesis II ranges from 17-44%.
The risk of neonatal weight loss is up to 7 times greater for exclusively breastfed infants of women who experience delayed lactogenesis II as compared to women who experience typical onset lactogenesisII. In a qualitative study of 114 lactating women, increasing BMI was significantly associated with maternal perceptions of delayed onset of lactogenesis II.
The United States Breastfeeding Committee supports exclusive breastfeeding for the first 6 months of life because it "may exert a small but positive influence in reducing the risk of obesity in childhood and later in life…" Breastfeeding has also been associated with decreased risk of maternal morbidities such as type 2 diabetes, subclinical cardiovascular disease and less abdominal visceral adiposity. Given that prolonged breastfeeding improves the overall health of the mother infant dyad, it is critical to obtain a better understanding of those factors predictive of successful breastfeeding outcomes.
At University of South Florida our clinics serve an ethnically diverse population which would benefit from directed efforts at improving breastfeeding. Before we can undertake such a plan we need to assess the contemporary factors impacting lactogenesis.
We plan to prospectively enroll 186 pregnant women into a protocol to examine factors associated with delayed lactogenesis. Ninety-three women will have a BMI of 30 or higher at the time of delivery and the other 93 women will have a BMI ≤ 29 at the time of delivery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Tampa, Florida, United States, 33606
- USF South Tampa Center
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Tampa, Florida, United States, 33610
- TGH Health Park Genesis Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- intend to attempt breastfeeding
- Expecting a live-born infant
- Singleton pregnancy
- English or Spanish language fluency
- Delivered at fullterm gestation
Exclusion Criteria:
- Multiple gestation delivery
- Delivered pre-term (<36weeks and 6 days of gestation)
- Not admitted to Mother Baby Unit (MBU) (ie admitted to intensive or special care unit or to Labor & Delivery Unit for postpartum monitoring)
- Mother did not initiate breastfeeding within 12 hours.
- No telephone access
- History of breast reduction or enlargement surgery
- Planning to formula feed from birth (no intention to breastfeed or try breastfeeding).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset of lactogenesis II
Time Frame: 2-5 days post delivery
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Women will be asked about the perception of the onset of their breastmilk coming such as breast engorgement.
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2-5 days post delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding duration
Time Frame: Six weeks post delivery
|
Women presenting for their 6 week postpartum exam will be asked to complete a short interview of 4 questions in regards to breastfeeding duration, "Measurement of intensity of breastfeeding behavior".
Exclusivity of breastfeeding will be based on Labbok's suggested levels of breastfeeding behaviors.Women will be asked "How is your infant feeding?
Why?" Responses will be categorized into exclusive, almost exclusive, partial high, partial low, token or no breastfeeding.
Women not currently breastfeeding will be asked when the infant last received any breast milk and what the reason is for stop breastfeeding.
If we miss the patient at their postpartum visit, we will complete the questionnaire by telephone.
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Six weeks post delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jessica Brumley, PhD, USF OB/GYN
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 00018603
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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