OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

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

Study Overview

• Status: Terminated
• Conditions: Osteopathic Manipulation
• Intervention / Treatment: Other: Osteopathic Manipulation

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32822
      • AdventHealth East Orlando

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactation Volume	Measuring lactation volume after osteopathic manipulation in ounces.	Baseline through 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in formula supplementation	Change in lactation production in order to change the number of ounces needed for formula supplementation.	Baseline to 4 weeks
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

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Arlene O'Donnell, DO, AdventHealth

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lactation; Insufficient, Partial; Lactating Female
• Other Study ID Numbers: 1174025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No