Reproductive Health Outcomes by Method of Breast Milk Feeding

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03568851
Study type	Observational
Source	University of California, Davis
Contact
Status	Completed
Phase
Start date	June 27, 2018
Completion date	January 14, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04487418` - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants	N/A
Completed	`NCT03334266` - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months	N/A
Enrolling by invitation	`NCT02687685` - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)	N/A
Completed	`NCT02913638` - A Post Breastfeeding Follow-Up Study	N/A
Completed	`NCT03033459` - Prenatal Lactation-Focused Motivational Interviewing	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Not yet recruiting	`NCT05846828` - Cognitive Functions in Breastfed Preschool Children
Completed	`NCT05944471` - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk	N/A
Completed	`NCT05629403` - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed	`NCT04024865` - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting	`NCT05560750` - Lingual Frenulum in Newborn Infants (LINNE)	N/A
Completed	`NCT03232762` - Effects of Diet on Pregnancy Outcome and Child Obesity	N/A
Recruiting	`NCT02186613` - Telephone Support From Primary Care for Breastfeeding Mothers	N/A
Completed	`NCT01687634` - Home Visiting for Low Income, Pregnant Women	N/A
Completed	`NCT01459991` - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women	N/A
Completed	`NCT03574766` - Meditation for NICU Moms	N/A
Recruiting	`NCT03945474` - Osteopathic Manipulation in Breastfed Newborns	N/A
Recruiting	`NCT06107933` - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting	`NCT05059574` - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies	N/A
Completed	`NCT04578925` - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.