Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy

NCT06570395 | Terminated

• 1 other identifier: MMMC#1637
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Osteopathic Manipulative Therapy (OMT) is a hands-on approach to treating conditions that affect all areas of the body. Physicians trained in OMT (Doctors of Osteopathic Medicine or DO) use OMT to correct structural imbalances in the body, relieve pain, and improve circulation. Research shows that manual therapy is equally or more effective in treating pain and improving function versus oral analgesics (Bodine). OMT can decrease cost and improve function in patients with a minimal adverse effect profile. OMT applications include relieving asthma, irritable bowel syndrome, fibromyalgia, migraines, carpal tunnel syndrome, and sports-related injuries. In addition to the indications listed above, there is a growing body of research surrounding the use of OMT in pregnancy and its use in treatment and prevention of complications peripartum. Research Question: Does OMT during the third trimester of pregnancy improve delivery outcomes including: decreased labor times, less utilization of analgesics, fewer incidences of meconium fluid and perineal lacerations, and reduced risk of conversion to c-section or operative vaginal delivery? Though all research has shown that OMT is safe in pregnancy, there has been conflicting data on its benefits during the peripartum period. Additional research is needed to show its utility in decreasing labor times and need for analgesics during labor and reducing incidence of adverse outcomes including perineal lacerations and conversion to c-section and operative vaginal delivery. The current study will add to the growing body of knowledge about OMT during pregnancy and its potential benefits outside of musculoskeletal pain relief.

Conditions

Pregnancy; Osteopathic Manipulative Treatment (OMT)

Keywords

Pregnancy; Osteopathic Manipulative Treatment (OMT); Delivery Outcomes; Third Trimester Pregnancy

Outcome Measures

Primary Outcomes (1)

• Labor duration

  Does OMT in the 3rd trimester of pregnancy shorten duration of labor? The investigators will compare a control group to a group who received OMT.

  Upon delivery

Secondary Outcomes (5)

• Number of patients with analgesic use during labor

  Upon delivery

• Degree of perineal laceration during labor

  Upon delivery

• Number of patients with meconium fluid upon delivery

  Upon delivery

• Number of patients who underwent operative vaginal delivery

  Upon delivery

• Number of patients who were converted to c-section

  Upon delivery

Study Arms (2)

OMT Intervention

The OMT intervention group will be patients who consent to participating in OMT through the Southwest Women's Clinic and Cass Community Clinic in Niles, MI. Case Inclusion: 1. Pregnant patients, ages 18-34 2. Primiparous and multiparous 3. Gestational age ≥34 weeks 4. Delivering at Corewell Health South Saint Joseph or Niles hospitals 5. Consent for treatment or as a control Case Exclusion: 1. Absolute contraindications to OMT 2. Acute abdomen 3. BP \>160/110 4. Unexplained visual disturbances 5. Heavy vaginal bleeding preceding delivery 6. \<34 weeks gestational age 7. Treatment refusal 8. Magnesium sulfate received for seizure prophylaxis in setting of preeclampsia w/ severe features or severe gestational HTN 9. Scheduled c-section due to prior OB conditions

Procedure: Osteopathic Manipulative Treatment

Control Group

The control group will be patients who consent to participating in the control group through the Southwest Women's Clinic and Cass Community Clinic in Niles, MI.

Interventions

Osteopathic Manipulative Treatment PROCEDURE

Osteopathic Manipulative Therapy (OMT) is a hands-on approach to treating conditions that affect all areas of the body. Physicians trained in OMT (Doctors of Osteopathic Medicine or DO) use OMT to correct structural imbalances in the body, relieve pain, and improve circulation. It is not only used as a treatment modality, but also to diagnose and prevent disease and improve overall functioning. There are over 40 OMT techniques that all involve gentle manipulation of the muscles, soft tissues, and joints in several ways to optimize alignment, improve blood flow, restore balance, and improve range of motion ("Osteopathic Manipulative Therapy \& OMT." Cleveland Clinic).

OMT Intervention

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Patients must be in third trimester of pregnancy to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients in the third trimester of pregnancy who opt into OMT treatments and meet the inclusion/exclusion criteria of the study.

You may qualify if:

• Pregnant patients, ages 18-34
• Primiparous and multiparous
• Gestational age ≥34 weeks
• Delivering at Corewell Health South Saint Joseph or Niles hospitals
• Consent for treatment or as a control

You may not qualify if:

• Absolute contraindications to OMT
• Acute abdomen
• BP \>160/110
• Unexplained visual disturbances
• Heavy vaginal bleeding preceding delivery
• \<34 weeks gestational age
• Treatment refusal
• Magnesium sulfate received for seizure prophylaxis in setting of preeclampsia w/ severe features or severe gestational HTN
• Scheduled c-section due to prior OB conditions

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Corewell Health Lakeland

Saint Joseph, Michigan, 49085, United States

Location

Related Publications (3)

• Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22.

  PMID: 20097115 BACKGROUND

• Roberts A, Harris K, Outen B, Bukvic A, Smith B, Schultz A, Bergman S, Mondal D. Osteopathic Manipulative Medicine: A Brief Review of the Hands-On Treatment Approaches and Their Therapeutic Uses. Medicines (Basel). 2022 Apr 27;9(5):33. doi: 10.3390/medicines9050033.

  PMID: 35622072 BACKGROUND

• Bodine WA. Osteopathic Manipulative Treatment: A Primary Care Approach. Am Fam Physician. 2019 Feb 15;99(4):214. No abstract available.

  PMID: 30763051 BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Max Schaefer, DO

  Corewell Health South

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 26, 2024
• Study Start: July 16, 2024
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)