BreastfeedingNCT02220413
Predictors of Lactogenesis II
An observational study of Breastfeeding, run by University of South Florida at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breastfeeding
- How many people
- 216 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2014to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- intend to attempt breastfeeding
- Expecting a live-born infant
- Singleton pregnancy
- English or Spanish language fluency
- Delivered at fullterm gestation
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tampa General Hospital
Tampa, Florida, 33606
USF South Tampa Center
Tampa, Florida, 33606
TGH Health Park Genesis Clinic
Tampa, Florida, 33610
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding
- Keywords
- Breastmilk, Lactogenesis, Obesity
- Medical subject headings
- Breast Feeding, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of lactogenesis II
Women will be asked about the perception of the onset of their breastmilk coming such as breast engorgement.
Measured: 2-5 days post delivery
Secondary outcomes (1)
Breastfeeding duration
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.
Measured: Six weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Brumley, PhD, Principal investigator, USF OB/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220413
- Sponsor's protocol ID
- 00018603
- Status last verified
- May 2016
- First submitted
- 15 Aug 2014
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Moderators of Delayed Lactogenesis II and Duration of Breastfeeding
- ClinicalTrials.gov ID
- NCT02220413
- Acronym / sponsor ID
- 00018603
- Conditions
- Breastfeeding
- Keywords
- Breastmilk, Lactogenesis, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- intend to attempt breastfeeding
- Expecting a live-born infant
- Singleton pregnancy
- English or Spanish language fluency
- Delivered at fullterm gestation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Onset of lactogenesis II
Time frame: 2-5 days post delivery
Women will be asked about the perception of the onset of their breastmilk coming such as breast engorgement.
1 secondary outcome
Breastfeeding duration
Time frame: Six weeks post delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Brumley, PhD principal investigator
USF OB/GYN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, run by University of South Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of lactogenesis II (time frame: 2-5 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.