Lactation

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37 Lactation Trials Near You

Power is an online platform that helps thousands of Lactation patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female

324 Participants Needed

Multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double-blind, randomized, controlled trial, the investigators will recruit 7- postpartum women who exclusively breastfeed at week 5 postpartum and randomly assign them to either receive the Ritual MVI which is commercially available or a blank placebo for 10 weeks. A blank placebo is appropriate because there is currently no recommendation or scientific consensus that lactating women who are healthy and eat a normal diet would have improved nutrition status or maternal-infant health outcomes from a nutrition supplement. The investigators will collect blood and breastmilk samples at baseline and end of the study to assess nutrient status. The investigators hypothesize that consumption of a Ritual MVI leads to better nutrition status and biomarkers in maternal-child dyads compared to control.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

70 Participants Needed

The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question\[s\] it aims to answer are: * Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people? * Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding? Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.
No Placebo Group
Prior Safety Data

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female

500 Participants Needed

The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care. The main questions it aims to answer are whether this set of interventions will improve trainee wellbeing and decrease medical error. Participants will be randomized to intervention and control groups. The intervention group will receive: 1. A Snoo smart sleep bassinet 2. A Willow wearable breast pump 3. Access to Maven Clinic for 24/7 on-demand perinatal care 4. A faculty mentor in their own department The control group will receive the standard support currently offered by training programs. All participants will wear a Fitbit to track sleep and will take a series of surveys querying pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction. Researchers will compare intervention and control groups to see if the intervention group has: 1. decreased rates of burnout 2. increased professional fulfillment 3. decreased thoughts of leaving the profession 4. increased perception of organizational and personal value alignment 5. increased sleep 6. decreased risk of medical errors 7. increased personal fulfillment of breastfeeding goals 8. decreased risk of postpartum depression
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

152 Participants Needed

This trial aims to help Black mothers of critically ill infants in the NICU by providing a wearable breast pump that can be used hands-free. The pump comes with an app that tracks how often they pump and how much milk they produce. This could make it easier for these mothers to provide more breast milk for their babies.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

40 Participants Needed

The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

50 Participants Needed

A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

30 Participants Needed

RE104 for Lactation

Las Vegas, Nevada
The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female

15 Participants Needed

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.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:14 - 50

50 Participants Needed

SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population. Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

40 Participants Needed

The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU) that cannot directly breastfeed.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

25 Participants Needed

Lysine Intake for Breastfeeding

Vancouver, British Columbia
The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 40
Sex:Female

15 Participants Needed

Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Sex:Female

72 Participants Needed

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
No Placebo Group
Prior Safety Data

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female

20 Participants Needed

Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States. Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months. Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female

10 Participants Needed

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 55
Sex:Female

10 Participants Needed

The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Sex:Female

15 Participants Needed

The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Sex:Female

15 Participants Needed

The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female

16 Participants Needed

This trial tests three ways to help calm children during stitches: two nose sprays (dexmedetomidine and midazolam) and a gas (nitrous oxide). It focuses on children who need stitches because they often feel very distressed. These methods work by making children feel sleepy or reducing their pain. Dexmedetomidine has been studied for its effectiveness in reducing agitation after tonsillectomy in children.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 12

300 Participants Needed

Why Other Patients Applied

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50
This trial is testing a new device called TELLTALE, designed to make heart valve replacement surgery safer. It targets patients over 21 who are at high risk of blocked blood flow to the heart. The device cuts a tissue flap that can cause this blockage, aiming to reduce complications and improve patient outcomes. This type of heart valve replacement has emerged as an effective treatment option in patients with severe aortic stenosis, supported by a series of studies.
Stay on current meds
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21+

139 Participants Needed

Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and ultimately, accidental bowel leakage. Women who suffer a severe vaginal laceration will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. All women will have immediate, intensive follow-up with an Urogynecologist at our well-established PEAPOD peripartum clinic at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection. At these visits, we also will assess women's perception of their well-being, perineal pain, and bowel symptoms. All participants will be invited to remain in the study for long-term follow-up. Our goal is to establish whether a five-day course of oral antibiotics should be a standard part of clinical care for severe postpartum lacerations.

Trial Details

Trial Status:Recruiting
Sex:Female

274 Participants Needed

This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS). Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:7 - 70

108 Participants Needed

Suture Materials for Hand Cuts

Hershey, Pennsylvania
This study aims to determine whether the use of non-absorbable (i.e. nylon) versus absorbable (i.e. chromic gut) sutures in traumatic hand lacerations affects wound healing, patient perception, and development of complications.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

32 Participants Needed

SCS for Spinal Cord Injury

Durham, North Carolina
This trial is testing Spinal Cord Stimulation (SCS) for patients with Spinal Cord Injury (SCI) to manage pain and improve physical functions. The treatment uses electrical pulses to interfere with pain signals and may help with movement and sensation. Patients will receive either active SCS treatment or their usual care. Spinal cord stimulation (SCS) has been used since 1967 and is an evidence-based treatment for various chronic pain disorders, including failed back surgery syndrome (FBSS).

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

30 Participants Needed

The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive with follow-up visits at 10 days and 30 days after application of tissue adhesive.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:22+

452 Participants Needed

Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female

100 Participants Needed

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:18 - 50

60 Participants Needed

Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:1 - 5

90 Participants Needed

Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 3

100 Participants Needed

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Frequently Asked Questions

How much do Lactation clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Lactation clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Lactation trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Lactation is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Lactation medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Lactation clinical trials?

Most recently, we added Ozanimod for Breastfeeding, Zilucoplan for Breastfeeding Assessment and Lidocaine vs Diphenhydramine for Skin Lacerations to the Power online platform.

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