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OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

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ClinicalTrials.gov Identifier: NCT03875794
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

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

Condition or disease Intervention/treatment Phase
Osteopathic Manipulation Other: Osteopathic Manipulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.




Primary Outcome Measures :
  1. Lactation Volume [ Time Frame: Baseline through 4 weeks ]
    Measuring lactation volume after osteopathic manipulation in ounces.


Secondary Outcome Measures :
  1. Change in formula supplementation [ Time Frame: Baseline to 4 weeks ]
    Change in lactation production in order to change the number of ounces needed for formula supplementation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Lactating females
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875794


Contacts
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Contact: Alane J Waters, MS, RN 407-303-5600 ext 1123319 alane.waters@adventhealth.com

Locations
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United States, Florida
AdventHealth East Orlando Recruiting
Orlando, Florida, United States, 32822
Contact: Alane Waters, MS, RN    407-303-5600 ext 1123319    alane.waters@adventhealth.com   
Sponsors and Collaborators
Florida Hospital
Investigators
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Principal Investigator: Eileen Conaway, DO AdventHealth

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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT03875794     History of Changes
Other Study ID Numbers: 1174025
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida Hospital:
Lactation; Insufficient, Partial
Lactating Female