PregnancyNCT06570395
Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy
An observational study of Pregnancy and Osteopathic Manipulative Treatment (OMT), run by Corewell Health South at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Osteopathic Manipulative Treatment (OMT)
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 29 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients in the third trimester of pregnancy who opt into OMT treatments and meet the inclusion/exclusion criteria of the study.
Who may be able to join
- 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
Who cannot join
- Absolute contraindications to OMT
- Acute abdomen
- BP >160/110
- Unexplained visual disturbances
- Heavy vaginal bleeding preceding delivery
- <34 weeks gestational age
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Corewell Health Lakeland
Saint Joseph, Michigan, 49085
About this study
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.
Read the 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.
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- Pregnancy, Osteopathic Manipulative Treatment (OMT), Delivery Outcomes, Third Trimester Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon delivery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Upon delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start16 Jul 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Why it stopped: Staff turnover led to difficulty in recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Schaefer, DO, Principal investigator, Corewell Health South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570395
- Sponsor's protocol ID
- MMMC#1637
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20097115Roberts 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.
PubMed 35622072Bodine WA. Osteopathic Manipulative Treatment: A Primary Care Approach. Am Fam Physician. 2019 Feb 15;99(4):214. No abstract available.
PubMed 30763051
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT06570395
- Acronym / sponsor ID
- MMMC#1637
- Keywords
- Pregnancy, Osteopathic Manipulative Treatment (OMT), Delivery Outcomes, Third Trimester Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Staff turnover led to difficulty in recruiting.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT Intervention | – | Procedure: Osteopathic Manipulative TreatmentThe 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 |
| 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients in the third trimester of pregnancy who opt into OMT treatments and meet the inclusion/exclusion criteria of the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Absolute contraindications to OMT
- Acute abdomen
- BP >160/110
- Unexplained visual disturbances
- Heavy vaginal bleeding preceding delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentOsteopathic 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). | Procedure or surgery | OMT Intervention |
Primary outcome
Labor duration
Time frame: Upon delivery
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.
5 secondary outcomes
Number of patients with analgesic use during labor
Time frame: Upon delivery
Degree of perineal laceration during labor
Time frame: Upon delivery
Number of patients with meconium fluid upon delivery
Time frame: Upon delivery
Number of patients who underwent operative vaginal delivery
Time frame: Upon delivery
Number of patients who were converted to c-section
Time frame: Upon delivery
Results and safety
The study was stopped early (reason given: Staff turnover led to difficulty in recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 20097115Carnes 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.
- Background: PubMed 35622072Roberts 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.
- Background: PubMed 30763051Bodine WA. Osteopathic Manipulative Treatment: A Primary Care Approach. Am Fam Physician. 2019 Feb 15;99(4):214. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Schaefer, DO principal investigator
Corewell Health South
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Osteopathic Manipulative Treatment (OMT), run by Corewell Health South at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Staff turnover led to difficulty in recruiting.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor duration (time frame: Upon delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570395, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.