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
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|
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 Type :||Observational|
|Estimated Enrollment :||394 participants|
|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|
- 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568851
|Contact: Melissa Chen, MDfirstname.lastname@example.org|
|United States, California|
|University of California, Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Melissa Chen, MD 916-734-6670 email@example.com|
|Principal Investigator: Melissa Chen, MD|
|Principal Investigator:||Melissa Chen, MD||UC Davis|