OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

Osteopathic Manipulation Clinical Trial

Official title:

OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03875794
• Other study ID #: 1174025
• Status: Terminated
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2022
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteopathic Manipulation

Intervention

Other:
• Osteopathic Manipulation
Using osteopathic manipulation as an intervention to increase milk supply in lactating women.

Locations

Country	Name	City	State
United States	AdventHealth East Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactation Volume	Measuring lactation volume after osteopathic manipulation in ounces.	Baseline through 4 weeks
Secondary	Change in formula supplementation	Change in lactation production in order to change the number of ounces needed for formula supplementation.	Baseline to 4 weeks
Secondary	Change in reported self-worth	Change in subject reported self-worth as assessed on an Investigator developed questionnaire (based off the Patient-Reported Outcomes Measurement Information System [PROMIS] questionnaire on a 5 point Likert scale).	Baseline to 4 weeks