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Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production

NCT02545127•Ferring Pharmaceuticals

View on ClinicalTrials.gov

Summary

Induction and support of lactation in women with preterm delivery and inadequate milk production.

Eligibility

Age

18 - 44 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Delivered at the hospital system associated with the trial center
•Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
•Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
•Produced \< 200 mL milk in 24 hours prior to randomization
•Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria

•Pre-pregnancy body mass index (BMI) \> 50 kg/m\^2
•Mastitis
•History of breast trauma, breast surgery, nipple piercing
•Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
•Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
•Unstable thyroid disease
•Moderate or severe renal or hepatic impairment
•Mental illness
•Significant nasal congestion or mucous production
•Use of anti-psychotic drugs within past 12 months

Locations (10)

Ferring Investigational Site

New Haven, Connecticut, United States

Ferring Investigational Site

South Bend, Indiana, United States

Ferring Investigational Site

Baltimore, Maryland, United States

Ferring Investigational Site

Boston, Massachusetts, United States

Ferring Investigational Site

Valhalla, New York, United States

Ferring Investigational Site

Raleigh, North Carolina, United States

Ferring Investigational Site

Cincinnati, Ohio, United States

Ferring Investigational Site

Charleston, South Carolina, United States

Ferring Investigational Site

Houston, Texas, United States

Ferring Investigational Site

San Antonio, Texas, United States

Key Dates

Start Date

May 28, 2021

Primary Completion Date

November 11, 2022

Completion Date

November 11, 2022

Last Updated

February 7, 2024

Enrollment

ACTUAL participants

Conditions

Preterm DeliveryInadequate Milk Production

Interventions

Merotocin

DRUG

Placebo

DRUG

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

NCT03596125

Preterm Delivery

View study

UNKNOWNNA

Cerclage After Full Dilatation Caesarean Section

NCT04110704

Preterm BirthPreterm Premature Rupture of Membrane+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Inclusion Criteria

Exclusion Criteria

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Cerclage After Full Dilatation Caesarean Section

Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery

Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor

Spontaneous Preterm Birth Marker Test