Reproductive Health Outcomes by Method of Breast Milk Feeding
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 15 - 45 |
| Updated: | 7/4/2018 |
| Start Date: | June 27, 2018 |
| End Date: | June 2021 |
| Contact: | Melissa Chen, MD |
| Email: | mejchen@ucdavis.edu |
| Phone: | 916-734-6670 |
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.
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.
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.
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.
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
We found this trial at
1
site
1 Shields Ave
Sacramento, California 95616
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Melissa Chen, MD
Phone: 916-734-6670
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