OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

Not Applicable

Terminated

• Conditions: Osteopathic Manipulation
• Interventions: Other: Osteopathic Manipulation

• Registration Number: NCT03875794
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Status Verified: 2022-04
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osteopathic Manipulation	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.

Primary Outcome Measures

Name	Time	Method
Lactation Volume	Baseline through 4 weeks	Measuring lactation volume after osteopathic manipulation in ounces.

Secondary Outcome Measures

Name	Time	Method
Change in formula supplementation	Baseline to 4 weeks	Change in lactation production in order to change the number of ounces needed for formula supplementation.
Change in reported self-worth	Baseline to 4 weeks	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).

Trial Locations

Locations (1)

AdventHealth East Orlando; 🇺🇸 Orlando, Florida, United States