Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 4:51 PM
Study NCT ID:
NCT03875794
Status:
TERMINATED
Last Update Posted:
2022-04-29
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
Sponsor:
AdventHealth
Organization:
Study Overview
Official Title:
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There is no one to transfer to study to and no one interested in this research study. I am taking 8 months off from being a physician so the study needs to be closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.
Detailed Description:
The short and long-term benefits of breastfeeding to both the mother and infant are well established. Benefits for the child range from protection against common childhood infections, decreased rates of type-2 diabetes and systolic hypertension, lower rate of sudden infant death syndrome, increased performance on intelligence tests, and possible reduction in obesity. Maternal benefits include a reduction in the risk of breast cancer, diabetes, hyperlipidemia, hypertension, myocardial infarction, obesity, and ovarian cancer. Given this evidence the World Health Organization (WHO) and the American Academy of Pediatrics recommend, exclusive breastfeeding of infants for the first six months. WHO goes on to recommend breastfeeding to 2 years and beyond if mutually agreeable to both the mother and child. Despite these benefits and recommendations, according to the Centers for Disease Control and Prevention (CDC) in the United States 81% of infants were started breastfeeding and only 51% continued at 6 months. Perceived or actual low milk supply is one of the most common reasons for discontinuing breastfeeding.
This protocol is designed to investigate scientifically our current osteopathic standard of care. There is no available research data to date specifically on using osteopathic manipulation as an intervention to increase milk supply in lactating women.
This protocol is designed to investigate scientifically our current osteopathic standard of care. There is no available research data to date specifically on using osteopathic manipulation as an intervention to increase milk supply in lactating women.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: