Reproductive Health Outcomes by Method of Breast Milk Feeding

Breast Feeding Clinical Trial

Official title:

Reproductive Health Outcomes by Method of Breast Milk Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568851
• Other study ID #: 1198922
• Status: Completed
• Start date: June 27, 2018
• Est. completion date: January 14, 2021

Study information

• Verified date: August 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Amenorrhea
• Amenorrhea, Postpartum
• Breast Feeding
• Milk Expression, Breast

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who are amenorrheic		6 months postpartum
Primary	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
Primary	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	Duration of lactation		within 6 months
Secondary	Time to resumption of sexual activity		within 6 months
Secondary	Duration of amenorrhea		within 6 months
Secondary	Time to initiation of another contraceptive method		within 6 months
Secondary	Proportion of women who meet criteria for lactational amenorrhea method		at 6 months postpartum
Secondary	Preliminary estimates of contraceptive efficacy of LAM		within 6 months postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum		1 month postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum		2 months postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum		3 months postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum		4 months postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum		5 months postpartum
Secondary	Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum		6 months postpartum
Secondary	Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping)		within 6 months postpartum