Clinical trial NCT03875794: OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
Official title: OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteopathic Manipulation
Keywords: Lactation; Insufficient, Partial
Lactating Female
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 40
2. Between 2 and 28 weeks postpartum from a live infant birth weighing at least 2500g
3. Desire to exclusively breastfeed
4. Able to provide informed consent
5. Available for the duration of the study
6. 1 hour milk volume of less than 1oz (or 2oz for twins)
7. All current nurslings are the same age

Exclusion Criteria:

1. Current use of domperidone
2. Current use of metoclopramide
3. Current use of silymarin
4. History of breast surgery
5. Current malignancy
6. Current pulmonary embolism or deep vein thrombosis
7. Current medical condition resulting in increased intra-cranial pressure
8. History of insufficient glandular tissue (IGT)

Primary outcomes:
measure: Lactation Volume
timeFrame: Baseline through 4 weeks
Secondary outcomes:
measure: Change in formula supplementation
timeFrame: Baseline to 4 weeks
measure: Change in reported self-worth
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth East Orlando
state: Florida
Study officials:
affiliation: AdventHealth
name: Arlene O'Donnell, DO
role: PRINCIPAL_INVESTIGATOR
References: