Clinical trial NCT06570395: Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy
Official title: Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy
Osteopathic Manipulative Treatment (OMT)
Keywords: Pregnancy
Osteopathic Manipulative Treatment (OMT)
Delivery Outcomes
Third Trimester Pregnancy
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Labor duration
timeFrame: Upon delivery
Secondary outcomes:
measure: Number of patients with analgesic use during labor
timeFrame: Upon delivery
measure: Degree of perineal laceration during labor
timeFrame: Upon delivery
measure: Number of patients with meconium fluid upon delivery
timeFrame: Upon delivery
measure: Number of patients who underwent operative vaginal delivery
timeFrame: Upon delivery
measure: Number of patients who were converted to c-section
timeFrame: Upon delivery
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Corewell Health Lakeland
state: Michigan
Study officials:
affiliation: Corewell Health Lakeland
name: Eric Pearson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Bodine WA. Osteopathic Manipulative Treatment: A Primary Care Approach. Am Fam Physician. 2019 Feb 15;99(4):214. No abstract available.