Reproductive Health Outcomes by Method of Breast Milk Feeding

Completed

Conditions studied: Breast Feeding, Milk Expression, Breast, Amenorrhea, Postpartum

In brief

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.

Key facts

Study ID

NCT03568851

Run by

University of California, Davis

People needed

394

Starts

2018-06-27

Expected to finish

2021-01-14

Last updated by the study team

2021-08-18

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.