Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Osteopathic Manipulative Treatment (OMT)
• Intervention / Treatment: Procedure: Osteopathic Manipulative Treatment

Detailed Description

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). 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.

Some OMT techniques are similar to those used by chiropractors, physical therapists, and massage therapists. What makes it unique is that osteopathic physicians are trained to apply the philosophies of OMT with their comprehensive medical training of all body systems to specifically adapt the treatment to each individual patient. They incorporate their vast knowledge of pathology and physiology with the philosophy that the body can self-heal and self-regulate.

While OMT is most known for its application in treating pain, it truly involves holistic examination of the whole patient - body, mind, and spirit - and can be applied to any situation that places stress upon the body. It is also adjusted based on the patient's condition, age, weight, and other characteristics to yield personalized treatment that can be an adjunct to treatment for virtually any disease or condition (Roberts). Other 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.

The current practice of obstetrics does not often incorporate the use of OMT in pregnancy to treat pain or prevent complications during and after delivery, despite evidence that it is safe. The investigators believe there is a need to focus attention on the effect of OMT on the rates of specific adverse events in labor and delivery.

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Corewell Health Lakeland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: 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 Case Exclusion: 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	Procedure: Osteopathic Manipulative Treatment; 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with analgesic use during labor	Does OMT in the 3rd trimester of pregnancy reduce the use of analgesic during labor? The investigators will compare a control group to a group who received OMT.	Upon delivery
Degree of perineal laceration during labor	Does OMT in the 3rd trimester of pregnancy reduce the extent of perineal laceration during labor? The investigators will compare a control group to a group who received OMT.	Upon delivery
Number of patients with meconium fluid upon delivery	Does OMT in the 3rd trimester of pregnancy reduce the presence of meconium fluid upon delivery? The investigators will compare a control group to a group who received OMT.	Upon delivery
Number of patients who underwent operative vaginal delivery	Does OMT in the 3rd trimester of pregnancy reduce number of patients who undergo operative vaginal delivery? The investigators will compare a control group to a group who received OMT.	Upon delivery
Number of patients who were converted to c-section	Does OMT in the 3rd trimester of pregnancy reduce number of patients who converted to C-section during delivery? The investigators will compare a control group to a group who received OMT.	Upon delivery

Collaborators and Investigators

• Sponsor: Corewell Health South
• Investigators: Principal Investigator: Max Schaefer, DO, Corewell Health South

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Osteopathic Manipulative Treatment (OMT); Delivery Outcomes; Third Trimester Pregnancy
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: MMMC#1637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data may be shared with other researchers on a case by case basis based on PI discretion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No