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Reproductive Health Outcomes by Method of Breast Milk Feeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568851
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

  • 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.

Condition or disease
Breast Feeding Milk Expression, Breast Amenorrhea, Postpartum

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.

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Study Type : Observational
Estimated Enrollment : 394 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproductive Health Outcomes by Method of Breast Milk Feeding
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  1. Proportion of women who are amenorrheic [ Time Frame: 6 months postpartum ]
  2. 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 ]
  3. 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


Secondary Outcome Measures :
  1. Duration of lactation [ Time Frame: within 6 months ]
  2. Time to resumption of sexual activity [ Time Frame: within 6 months ]
  3. Duration of amenorrhea [ Time Frame: within 6 months ]
  4. Time to initiation of another contraceptive method [ Time Frame: within 6 months ]
  5. Proportion of women who meet criteria for lactational amenorrhea method [ Time Frame: at 6 months postpartum ]
  6. Preliminary estimates of contraceptive efficacy of LAM [ Time Frame: within 6 months postpartum ]
  7. Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum [ Time Frame: 1 month postpartum ]
  8. Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum [ Time Frame: 2 months postpartum ]
  9. Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum [ Time Frame: 3 months postpartum ]
  10. Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum [ Time Frame: 4 months postpartum ]
  11. Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum [ Time Frame: 5 months postpartum ]
  12. Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum [ Time Frame: 6 months postpartum ]
  13. Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping) [ Time Frame: within 6 months postpartum ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Describes self as female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.
Criteria

MAIN STUDY

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • are no longer interested in study participation

SUB-STUDY

Inclusion Criteria:

  • enrolled in the main study
  • within 8 weeks postpartum after delivering a singleton
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568851


Contacts
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Contact: Melissa Chen, MD 916-734-6670 mejchen@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Melissa Chen, MD    916-734-6670    mejchen@ucdavis.edu   
Principal Investigator: Melissa Chen, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Melissa Chen, MD UC Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03568851    
Other Study ID Numbers: 1198922
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amenorrhea
Menstruation Disturbances
Pathologic Processes