Reproductive Health Outcomes by Method of Breast Milk Feeding

NCT03568851 | Completed

• 1 other identifier: 1198922
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Feeding; Milk Expression, Breast; Amenorrhea, Postpartum

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (13)

• Duration of lactation

  within 6 months

• Time to resumption of sexual activity

  within 6 months

• Duration of amenorrhea

  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

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Describes self as female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who are planning on breastmilk feeding for at least 6 months after delivery of a singleton.

You may qualify if:

• 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
• 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
• 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
• less than 18 years old
• have a previous history of irregular or anovulatory cycles

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression; Amenorrhea

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Chen, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 26, 2018
• Study Start: June 27, 2018
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

US (1)