Breast FeedingNCT03568851
Reproductive Health Outcomes by Method of Breast Milk Feeding
An observational study of Breast Feeding and Milk Expression, Breast, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this research is to determine whether there are differences in ovarian suppression between women who are feeding at the breast compared with women who are pumping. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Breast Feeding, Milk Expression, Breast, Amenorrhea, Postpartum
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2018to 14 Jan 2021
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.
Who may be able to join
- 15 through 45 years old
- planning to feeding her infant exclusively the mother's own milk for at least 6 months after delivery
- receiving prenatal care, plan to deliver, and plan to return to UC Davis for the postpartum visit
- 32 weeks gestation or greater at screening
- enrolled in the main study
- within 8 weeks postpartum after delivering a singleton
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- currently amenorrheic
- planning to continue breastmilk feeding for up to 6 months after delivery
- planning to avoid pregnancy in the first 6 months after delivery
Who cannot join
- have a multiple gestation pregnancy
- planning to initiate a hormonal contraceptive method at the postpartum visit
- At time of delivery hospitalization, a second eligibility verification will occur and women will be excluded if they:
- initiated a hormonal contraceptive method (specifically intrauterine device, implant, depo provera injections) during the delivery hospitalization
- had a hysterectomy
- did not deliver at UC Davis
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- are no longer interested in study participation
- SUB-STUDY
- less than 18 years old
- have a previous history of irregular or anovulatory cycles
- are using a hormonal method of contraception
- are unwilling to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
The purpose of this research is to determine whether there are differences in ovarian suppression between women who are feeding at the breast compared with women who are pumping.
- In the main study, the aim is to compare reproductive health outcomes, including amenorrhea rates, duration of lactation, and resumption of sexual activity, between mothers who are exclusively breastfeeding (i.e. feeding at the breast) and those who are pumping after a term or preterm delivery.
- In the sub-study, the aim is to determine the feasibility and acceptability of using urinary luteinizing hormone (LH) detection kits at home to detect ovulation in exclusively breastmilk feeding women.
Read the detailed description
Women will be recruited for this study during routine prenatal care. Interested and eligible participants will undergo an informed consent process. After, participants will answer questions regarding demographic information, medical history, obstetric and reproductive history, previous lactation history, and the Infant Feeding Intentions questionnaire.
Participants who are eligible after the second eligibility verification at the time of delivery hospitalization will be enrolled in the study. Enrolled participants will be given breastmilk and infant feeding logs to complete. Study staff will contact participants at 1, 2, 3, 4, 5, and 6 months after delivery to ask about breastmilk feeding practices in the last 24 hours, infant feeding, vaginal bleeding, sexual activity, use of contraceptive methods, and repeat pregnancies. In between the monthly phone calls, study staff will ask participants about the occurrence of vaginal bleeding.
For the sub-study, participants are recruited from the main study. Those who are eligible and interested will undergo an informed consent process. Participants will be given urinary LH detection kits and instructions for use at time of enrollment. Daily urine LH testing will start after 8 weeks postpartum. Participants will also receive monthly diaries to complete in addition to the breastmilk and infant feeding logs in the main study. Study staff will contact participants at 2, 3, 4, 5, and 6 months to review the diary information. If the urine LH test is positive, the participant will undergo a blood draw for serum progesterone levels to confirm ovulation.
The planned enrollment is 394 participants for the main study and 40 participants in the sub-study.
- Medical subject headings
- Breast Feeding, Breast Milk Expression, Amenorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who are amenorrheic
Measured: 6 months postpartum
Proportion of ovulation detected, as measured by serum progesterone levels greater than or equal to 3 ng/mL, in women with a positive urine luteinizing hormone test
Measured: 6 months postpartum
Proportion of women who would use the urine luteinizing hormone tests again
Survey question with responses of yes, no, unsure/maybe
Measured: 6 months postpartum
Secondary outcomes (13)
Duration of lactation
Measured: within 6 months
Time to resumption of sexual activity
Measured: within 6 months
Duration of amenorrhea
Measured: within 6 months
Time to initiation of another contraceptive method
Measured: within 6 months
Proportion of women who meet criteria for lactational amenorrhea method
Measured: at 6 months postpartum
Preliminary estimates of contraceptive efficacy of LAM
Measured: within 6 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum
Measured: 1 month postpartum
Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum
Measured: 2 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum
Measured: 3 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum
Measured: 4 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum
Measured: 5 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum
Measured: 6 months postpartum
Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping)
Measured: within 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start27 Jun 2018
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Chen, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568851
- Sponsor's protocol ID
- 1198922
- Status last verified
- Aug 2021
- First submitted
- 31 May 2018
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Health Outcomes by Method of Breast Milk Feeding
- ClinicalTrials.gov ID
- NCT03568851
- Acronym / sponsor ID
- 1198922
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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 research is to determine whether there are differences in ovarian suppression between women who are feeding at the breast compared with women who are pumping.
- In the main study, the aim is to compare reproductive health outcomes, including amenorrhea rates, duration of lactation, and resumption of sexual activity, between mothers who are exclusively breastfeeding (i.e. feeding at the breast) and those who are pumping after a term or preterm delivery.
- In the sub-study, the aim is to determine the feasibility and acceptability of using urinary luteinizing hormone (LH) detection kits at home to detect ovulation in exclusively breastmilk feeding women.
Detailed description
Women will be recruited for this study during routine prenatal care. Interested and eligible participants will undergo an informed consent process. After, participants will answer questions regarding demographic information, medical history, obstetric and reproductive history, previous lactation history, and the Infant Feeding Intentions questionnaire.
Participants who are eligible after the second eligibility verification at the time of delivery hospitalization will be enrolled in the study. Enrolled participants will be given breastmilk and infant feeding logs to complete. Study staff will contact participants at 1, 2, 3, 4, 5, and 6 months after delivery to ask about breastmilk feeding practices in the last 24 hours, infant feeding, vaginal bleeding, sexual activity, use of contraceptive methods, and repeat pregnancies. In between the monthly phone calls, study staff will ask participants about the occurrence of vaginal bleeding.
For the sub-study, participants are recruited from the main study. Those who are eligible and interested will undergo an informed consent process. Participants will be given urinary LH detection kits and instructions for use at time of enrollment. Daily urine LH testing will start after 8 weeks postpartum. Participants will also receive monthly diaries to complete in addition to the breastmilk and infant feeding logs in the main study. Study staff will contact participants at 2, 3, 4, 5, and 6 months to review the diary information. If the urine LH test is positive, the participant will undergo a blood draw for serum progesterone levels to confirm ovulation.
The planned enrollment is 394 participants for the main study and 40 participants in the sub-study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.
Key inclusion criteria (9 listed)
- 15 through 45 years old
- planning to feeding her infant exclusively the mother's own milk for at least 6 months after delivery
- receiving prenatal care, plan to deliver, and plan to return to UC Davis for the postpartum visit
- 32 weeks gestation or greater at screening
- enrolled in the main study
Key exclusion criteria (12 listed)
- have a multiple gestation pregnancy
- planning to initiate a hormonal contraceptive method at the postpartum visit
- At time of delivery hospitalization, a second eligibility verification will occur and women will be excluded if they:
- initiated a hormonal contraceptive method (specifically intrauterine device, implant, depo provera injections) during the delivery hospitalization
- had a hysterectomy
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
Proportion of women who are amenorrheic
Time frame: 6 months postpartum
Proportion of ovulation detected, as measured by serum progesterone levels greater than or equal to 3 ng/mL, in women with a positive urine luteinizing hormone test
Time frame: 6 months postpartum
Proportion of women who would use the urine luteinizing hormone tests again
Time frame: 6 months postpartum
Survey question with responses of yes, no, unsure/maybe
13 secondary outcomes
Duration of lactation
Time frame: within 6 months
Time to resumption of sexual activity
Time frame: within 6 months
Duration of amenorrhea
Time frame: within 6 months
Time to initiation of another contraceptive method
Time frame: within 6 months
Proportion of women who meet criteria for lactational amenorrhea method
Time frame: at 6 months postpartum
Preliminary estimates of contraceptive efficacy of LAM
Time frame: within 6 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum
Time frame: 1 month postpartum
Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum
Time frame: 2 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum
Time frame: 3 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum
Time frame: 4 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum
Time frame: 5 months postpartum
Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum
Time frame: 6 months postpartum
Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping)
Time frame: within 6 months postpartum
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 18 Aug 2021.
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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.
Melissa Chen, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding and Milk Expression, Breast, run by University of California, Davis at 1 site 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 9 inclusion and 12 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of women who are amenorrheic (time frame: 6 months postpartum). The study lists 3 primary outcomes in all. 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 18 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.