Study Stopped
There is no one to transfer to study to and no one interested in this research study. I am taking 8 months off from being a physician so the study needs to be closed
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
1 other identifier
interventional
5
1 country
1
Brief Summary
This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2019
CompletedFirst Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedApril 29, 2022
April 1, 2022
3.2 years
March 13, 2019
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lactation Volume
Measuring lactation volume after osteopathic manipulation in ounces.
Baseline through 4 weeks
Secondary Outcomes (2)
Change in formula supplementation
Baseline to 4 weeks
Change in reported self-worth
Baseline to 4 weeks
Study Arms (1)
Osteopathic Manipulation
EXPERIMENTALThis 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.
Interventions
Using osteopathic manipulation as an intervention to increase milk supply in lactating women.
Eligibility Criteria
You may qualify if:
- Age 18 - 40
- Between 2 and 28 weeks postpartum from a live infant birth weighing at least 2500g
- Desire to exclusively breastfeed
- Able to provide informed consent
- Available for the duration of the study
- hour milk volume of less than 1oz (or 2oz for twins)
- All current nurslings are the same age
You may not qualify if:
- Current use of domperidone
- Current use of metoclopramide
- Current use of silymarin
- History of breast surgery
- Current malignancy
- Current pulmonary embolism or deep vein thrombosis
- Current medical condition resulting in increased intra-cranial pressure
- History of insufficient glandular tissue (IGT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
Study Sites (1)
AdventHealth East Orlando
Orlando, Florida, 32822, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arlene O'Donnell, DO
AdventHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 15, 2019
Study Start
January 29, 2019
Primary Completion
April 15, 2022
Study Completion
April 15, 2022
Last Updated
April 29, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share