OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

NCT ID: NCT03875794

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2022-04-15

Brief Summary

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.

Conditions

Osteopathic Manipulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Osteopathic Manipulation

Intervention Type: OTHER

Using osteopathic manipulation as an intervention to increase milk supply in lactating women.

Interventions

Osteopathic Manipulation

Using osteopathic manipulation as an intervention to increase milk supply in lactating women.

Intervention Type: OTHER

Eligibility 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

8. History of insufficient glandular tissue (IGT)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arlene O'Donnell, DO

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

AdventHealth East Orlando

Orlando, Florida, United States

Countries

United States

Other Identifiers

1174025

Identifier Type: -

Identifier Source: org_study_id