Osteopathic ManipulationNCT03875794
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
A study testing Osteopathic Manipulation in people with Osteopathic Manipulation, run by AdventHealth at 1 site in United States.
Trial summary
This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulation
- What is being tested?
- Osteopathic Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 1 hour milk volume of less than 1oz (or 2oz for twins)
- All current nurslings are the same age
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.
Read the 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.
- Conditions
- Osteopathic Manipulation
- Being tested
- Osteopathic Manipulation
- Keywords
- Lactation; Insufficient, Partial, Lactating Female
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic ManipulationOther
Using osteopathic manipulation as an intervention to increase milk supply in lactating women.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulation | Experimental | 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. Receives: Other: Osteopathic Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactation Volume
Measuring lactation volume after osteopathic manipulation in ounces.
Measured: Baseline through 4 weeks
Secondary outcomes (2)
Change in formula supplementation
Change in lactation production in order to change the number of ounces needed for formula supplementation.
Measured: 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).
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start29 Jan 2019
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteopathic ManipulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arlene O'Donnell, DO, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875794
- Sponsor's protocol ID
- 1174025
- Status last verified
- Apr 2022
- First submitted
- 13 Mar 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conaway EM, O'Donnell AE. Osteopathic manipulation to increase lactation quantity: a prospective case series. J Osteopath Med. 2025 Jun 16;125(11):547-552. doi: 10.1515/jom-2024-0250. eCollection 2025 Nov 1.
PubMed 40514083
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
- ClinicalTrials.gov ID
- NCT03875794
- Acronym / sponsor ID
- 1174025
- Conditions
- Osteopathic Manipulation
- Keywords
- Lactation; Insufficient, Partial, Lactating Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulation | Experimental | Other: Osteopathic ManipulationThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Current use of domperidone
- Current use of metoclopramide
- Current use of silymarin
- History of breast surgery
- Current malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic ManipulationUsing osteopathic manipulation as an intervention to increase milk supply in lactating women. | Other | Osteopathic Manipulation |
Primary outcome
Lactation Volume
Time frame: Baseline through 4 weeks
Measuring lactation volume after osteopathic manipulation in ounces.
2 secondary outcomes
Change in formula supplementation
Time frame: Baseline to 4 weeks
Change in reported self-worth
Time frame: Baseline to 4 weeks
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 40514083Conaway EM, O'Donnell AE. Osteopathic manipulation to increase lactation quantity: a prospective case series. J Osteopath Med. 2025 Jun 16;125(11):547-552. doi: 10.1515/jom-2024-0250. eCollection 2025 Nov 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene O'Donnell, DO principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulation in people with Osteopathic Manipulation, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactation Volume (time frame: Baseline through 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.