Lactation

12

Review clinical trials related to Lactation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication. Participation in this study could last up to 94 days, including screening and follow-up period.

Participants needed: 14
Trial details
Phase: Phase 4Age: 3+Biological sex: FemaleType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 15, 2026Locations: 22
Eligibility criteria

Mothers who are at minimum 18 years of age and their infants who are at least 36... [+4]

Have a history of inadequate lactation, for multiparous participants who have pr... [+4]

Status: Recruiting

Postpartum Acupressure Education and Breastfeeding Outcomes

This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.

Participants needed: 360
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Nigde Omer Halisdemir UniversityUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Age 18 to 45 years [+6]

Contraindications to breastfeeding (e.g., infant galactosemia) [+5]

Status: Not yet recruiting

RELIANCE: Moringa in Lactation and Early Childhood

This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years. Women must be \>18 years of age, ≤ 30 days postpartum and exclusively breastfeeding at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk. After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, and 6 months. Serum from mothers will be collected at recruitment, 2, 6,and 9 months; infant serum will be collected by capillary sample at recruitment and approximately at 4, 6, 12, 18, and 24 months. Infant hemoglobin and infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. 24-hour dietary recall: the foods and drinks consumed by mothers in the 24 hours prior to each milk sample. Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.

Participants needed: 100
Trial details
Age: 7-99Biological sex: FemaleType: InterventionalSponsor: Philip KernUpdated: May 22, 2026Locations: 1
Eligibility criteria

Mothers: Inclusion criteria - >18 years of age, s/p delivery of a healthy infant... [+1]

Mothers - women reporting regular consumption of moringa in the last month (>1 t... [+2]

Status: Recruiting

Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success

The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration. However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.

Participants needed: 167
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Acibadem UniversityUpdated: Mar 24, 2026Locations: 1
Eligibility criteria

Primiparous or multiparous women aged 18 years and older [+3]

Complications requiring sedation [+2]

Status: Recruiting

Postnatal Exercise to Activate Baby's Brown Fat

The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.

Participants needed: 200
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Joslin Diabetes CenterUpdated: Mar 12, 2026Locations: 2
Eligibility criteria

18-45 y of age at the time of enrollment [+5]

Any obstetric contra-indication to exercise at 1 month [+7]

Status: Recruiting

Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Participants needed: 40
Trial details
Age: 20+Biological sex: FemaleType: InterventionalSponsor: Mayo ClinicUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Maternal age > 20 years of age [+6]

Maternal extensive existing mindfulness practice [+5]

Status: Recruiting

Medicines in Breast Milk and Estimated Infant Exposure

The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding

Participants needed: 250
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University Hospital Bispebjerg and FrederiksbergUpdated: Jan 16, 2026Locations: 3
Eligibility criteria

Lactating women aged ≥18 years [+2]

Current pregnancy during sample collection [+1]

Status: Not yet recruiting

Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood

The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.

Participants needed: 784
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Medical University of ViennaUpdated: Jul 22, 2025Locations: 1
Eligibility criteria

Women aged 18 to 50 years at the time of delivery [+5]

Women younger than 18 or older than 50 at the time of delivery [+3]

Status: Recruiting

The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women

This clinical trial aims to determine whether heat stress alters 24-hour breast milk production and composition following an acute bout of exercise in the heat among lactating women. The main questions are: 1. To ascertain whether heat stress alters 24-hour breast milk production following acute exercise in the heat among lactating women. We hypothesize that breast milk production will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Lactating mothers will complete an acute exercise bout at 40% of their peak oxygen consumption (VO2peak) for 60 mins in a hot (36 °C, 40% relative humidity) and thermoneutral environment (20 °C, 20% relative humidity). Participants will record their total breast milk production in a 24-hour period using an infant scale. 2. to discover whether heat stress impacts the energy composition of breast milk following acute exercise in the heat among lactating women. We hypothesize that energy density will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Participants will use a manual expression breast pump to collect 10 mL of breast milk from each breast immediately and 24 hours post-exercise. Energy density (lactose, protein, and lipid content) will be assessed via enzyme-linked immunosorbent assays. Participants will complete the following visits: 1) initial consent visit 2) baseline testing; 3) acute exercise in the hot condition (HOT; 36C, 40% relative humidity), and 4) acute exercise in the temperate, thermoneutral condition (TEMP; 20C, 20% relative humidity). The baseline testing day will measure participant anthropometrics including height, weight, and body composition measured by a DEXA scan. For both experimental trials, participants will be asked to walk on a treadmill at based on their metabolic heat production (8W/kg) for 60 minutes. Heart rate (HR), mean skin temperature (Tsk), core temperature (Tcore), sweat loss (SL), and fluid intake will be measured throughout the exercise protocol. Breast milk composition will be measured through milk expression using a manual expression breast pump immediately and 24 hours post-exercise. Participants will log their breast milk production for 24 hours following the exercise using an infant scale to measure their infants before and after each feed.

Participants needed: 10
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Providence CollegeUpdated: Jun 25, 2025Locations: 1
Eligibility criteria

Currently breastfeeding or pumping expressed breastmilk for their 6-week to 24-m... [+2]

Obsterical complications during pregnancy [+3]

Status: Not yet recruiting

Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium

Pharmacotherapy for lactating women in Hungary presents a unique challenge. While certain medications may pose risks to the infant or reduce breast milk production, the unnecessary avoidance of treatment can also be harmful. Despite this, no dedicated Hungarian website currently provides guidance on the safe use of over-the-counter (OTC) medications for breastfeeding mothers. To address this gap, the aim is to develop a website that not only meets clinical standards but also presents essential information in a clear, accessible format that helps mothers understand and retain key details by choosing the best medium. Our main question is: What is the most effective way to educate lactating women about OTC medication use through an online platform?

Participants needed: 380
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Semmelweis UniversityUpdated: Mar 11, 2025
Eligibility criteria

Target population is adult (>18 years), 3rd trimester pregnant women; and breast... [+1]

A mother will not breastfeed, either because they cannot or do not want it. [+1]

Status: Recruiting

Drug Excretion in Breast Milk

This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.

Participants needed: 50
Trial details
Phase: Phase 4Age: 14-50Biological sex: AllType: InterventionalSponsor: University of WashingtonUpdated: Aug 6, 2024Locations: 1
Eligibility criteria

Healthy postpartum women [+2]

Receiving cimetidine within the 3 days prior to each study day. Concomitant admi... [+7]

Status: Recruiting

Iron Absorption and Requirements in Pregnancy and Lactation

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common. The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya. In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.

Participants needed: 250
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: University of OxfordUpdated: Aug 3, 2023Locations: 1
Eligibility criteria

Providing consent to the informed consent form [+4]

Pre-pregnancy body mass index >30 kg/m2 [+3]