An observational study in Breast Feeding, Milk Expression, Breast and Amenorrhea, Postpartum, sponsored by University of California, Davis. Completed at 1 site in United States. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by University of California, Davis · Observational
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.
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.
80 studies on the registry are indexed under Amenorrhea; 13 are open to participants now.
This study's enrollment of 394 is above the median of 101 across 34 observational studies indexed under Amenorrhea.
Browse Amenorrhea studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.
MAIN STUDY
Inclusion Criteria:
Exclusion Criteria:
At time of delivery hospitalization, a second eligibility verification will occur and women will be excluded if they:
SUB-STUDY
Inclusion Criteria:
Exclusion Criteria:
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
Survey question with responses of yes, no, unsure/maybe
Time frame: 6 months postpartum
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
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of California, Davis