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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
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This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulation | Other | Using osteopathic manipulation as an intervention to increase milk supply in lactating women. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactation Volume | Measuring lactation volume after osteopathic manipulation in ounces. | Baseline through 4 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Lactating females
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| Name | Affiliation | Role |
|---|---|---|
| Arlene O'Donnell, DO | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth East Orlando | Orlando | Florida | 32822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40514083 | Derived | 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. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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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 |
| D012046 | Rehabilitation |