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Completed

NCT Number: NCT03568851

Reproductive Health Outcomes by Method of Breast Milk Feeding

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.

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Key information

Conditions

Breast Feeding Amenorrhea Amenorrhea, Postpartum Behavior Breast Milk Expression Feeding Behavior Menstruation Disturbances Milk Expression, Breast Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of women who are amenorrheic

    Time frame: 6 months postpartum

  2. 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

  3. 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

Secondary outcomes

  1. Duration of lactation

    Time frame: within 6 months

  2. Time to resumption of sexual activity

    Time frame: within 6 months

  3. Duration of amenorrhea

    Time frame: within 6 months

  4. Time to initiation of another contraceptive method

    Time frame: within 6 months

  5. Proportion of women who meet criteria for lactational amenorrhea method

    Time frame: at 6 months postpartum

  6. Preliminary estimates of contraceptive efficacy of LAM

    Time frame: within 6 months postpartum

  7. Proportion of women feeding at breast, expressing milk, or both at month 1 postpartum

    Time frame: 1 month postpartum

  8. Proportion of women feeding at breast, expressing milk, or both at month 2 postpartum

    Time frame: 2 months postpartum

  9. Proportion of women feeding at breast, expressing milk, or both at month 3 postpartum

    Time frame: 3 months postpartum

  10. Proportion of women feeding at breast, expressing milk, or both at month 4 postpartum

    Time frame: 4 months postpartum

  11. Proportion of women feeding at breast, expressing milk, or both at month 5 postpartum

    Time frame: 5 months postpartum

  12. Proportion of women feeding at breast, expressing milk, or both at month 6 postpartum

    Time frame: 6 months postpartum

  13. Time to ovulation by method of breastmilk feeding (i.e. primarily breastfeeding or primarily pumping)

    Time frame: within 6 months postpartum

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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