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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who are amenorrheic | 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 | 6 months postpartum | |
| Proportion of women who would use the urine luteinizing hormone tests again | Survey question with responses of yes, no, unsure/maybe | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of lactation | within 6 months | |
| Time to resumption of sexual activity | within 6 months | |
| Duration of amenorrhea |
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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:
Describes self as female
Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Chen, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D061186 | Breast Milk Expression |
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
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| within 6 months |
| Time to initiation of another contraceptive method | within 6 months |
| Proportion of women who meet criteria for lactational amenorrhea method | at 6 months postpartum |
| Preliminary estimates of contraceptive efficacy of LAM | within 6 months postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum | 1 month postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum | 2 months postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum | 3 months postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum | 4 months postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum | 5 months postpartum |
| Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum | 6 months postpartum |
| Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping) | within 6 months postpartum |
| D013568 |
| Pathological Conditions, Signs and Symptoms |