OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
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|ClinicalTrials.gov Identifier: NCT03875794|
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteopathic Manipulation||Other: Osteopathic Manipulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Osteopathic Manipulation
This research will be carried out as a prospective, non-randomized pilot study in women aged 18-40 who are 2 weeks to 28 weeks postpartum.
The intervention investigated in this study is osteopathic manipulation.
Other: Osteopathic Manipulation
Using osteopathic manipulation as an intervention to increase milk supply in lactating women.
- Lactation Volume [ Time Frame: Baseline through 4 weeks ]Measuring lactation volume after osteopathic manipulation in ounces.
- Change in formula supplementation [ Time Frame: Baseline to 4 weeks ]Change in lactation production in order to change the number of ounces needed for formula supplementation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875794
|Contact: Alane J Waters, MS, RN||407-303-5600 ext firstname.lastname@example.org|
|United States, Florida|
|AdventHealth East Orlando||Recruiting|
|Orlando, Florida, United States, 32822|
|Contact: Alane Waters, MS, RN 407-303-5600 ext 1123319 email@example.com|
|Principal Investigator:||Eileen Conaway, DO||AdventHealth|