Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy
Conditions: Pregnancy, Osteopathic Manipulative Treatment (OMT)
Sponsor: Corewell Health South

Title: Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy 
NCT#: NCT06570395 
Date: 05/27/2025 
 

Abstract/Intro 
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. 
Problem and/or Purpose Statement- Objective of the Research 
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. We 
believe there is a need to focus attention on the effect of OMT on the rates of specific adverse 
events in labor and delivery. 
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? 
Explanation of need for the study: 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. 
How results will contribute to existing knowledge: Our study will add to the growing body of 
knowledge about OMT during pregnancy and its potential benefits outside of musculoskeletal 
pain relief. 
Background information 
Hypothesis: OMT in the third trimester of pregnancy will reduce incidence of adverse outcomes 
including: conversion to operative vaginal deliveries (OVD) and cesarean sections (CS), 
decrease the use of analgesics during labor, shorten labor times and reduce the incidence of 
meconium fluid. Conversion to cesarean section or operative vaginal delivery is sometimes 
unavoidable for the safety of both the mother and baby but they do come with their own set of 
risks. C-sections incur the same risks of other operative procedures including hemorrhage, 
infection, embolism, and damage to other organs (“C-Section” Cleavland Clinic). Risks 
associated with operative vaginal deliveries, those performed with forceps or vacuum devices, 
have the risk of tears to the muscles of the vagina or rectum, which may cause difficulty 
urinating or urinary incontinence. Risks to the baby include scalp edema, bruising leading to 
jaundice, cephalohematoma, and skull fractures (“Forcep Delivery” and “Vacuum Extraction 
Delivery,” Cleavland Clinic). 
Theoretical Framework- Present Knowledge 
Current data supports that OMT is safe for use in pregnant patients. Osteopathic manipulative 
treatment is used daily to treat patients at the Longmeadow Primary Care Residency Clinic. 
Literature Review 
A retrospective study published in 2003, looked at the medical records of women from 4 
different cities who did receive prenatal OMT compared to women in those same cities who did 
not receive prenatal OMT. The study looked for the occurrence of meconium fluid, preterm 
delivery, operative vaginal delivery (forceps delivery) and conversion to c-section (King et al). 
The types of OMT used varied based on the needs of the patient and the individual osteopathic 
structural examination. Two of the study sites had a single physician who performed OMT on all 
the study participants while the other two sites used several staff physicians and residents to 
perform OMT on the study participants. The study found that the participants who received OMT 
were significantly older (28.32yo vs 26.89yo) than those who did not receive OMT and yet they 
had fewer complications of labor and delivery than the group that did not receive OMT (King et 
al). The study concluded that if older women have a higher incidence of poor labor and delivery 
outcomes it should be even harder to obtain favorable study outcomes among this age group. 
This study also found that OMT was consistently associated with favorable labor outcomes and 
lower rates of meconium fluid, preterm delivery, and operative vaginal delivery. While the use of 
several physicians could introduce error into the study the positive results suggest further 
validity of OMT in the setting of labor and delivery. 

A literature review in 2012 by John M. Lavelle, DO, looked at the ability of OMT to improve the 
quality of life of pregnant women by treating somatic dysfunction caused by the rapid changes in 
the maternal body. He stated that data supported the benefit of OMT in lower back and pelvic 
pain in pregnancy but 
also stated that there were not enough randomized controlled trials to support the use of OMT in 
the prenatal patient (Lavelle). 
A systematic review of OMT in gynecology and obstetrics (Ruffini et al.) concluded that the 
small number of studies and high risk of bias prevented any indication on effect of OMT care. 
This literature review looked at 24 studies ranging in topics from low back and pelvic pain in 
pregnancy to infertility and dysmenorrhea. It also looked at analgesic use during labor and 
delivery. The authors concluded that OMT could be effective on pregnancy related back pain 
but was uncertain in other gynecologic and obstetric conditions. Only three studies listed 
adverse events following OMT, lacking sufficient data for analysis (Ruffini et al). 
The Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects 
(PROMOTE) study from 2016 (Hensel et al) studied the application of OMT to manage pain and 
dysfunction in pregnant patients during their third trimester. Patients were randomized to either 
OMT, usual care plus placebo ultrasound, or usual care and the incidence of high-risk status 
and labor and delivery outcomes were analyzed. Results showed that high-risk status was less 
likely to develop in patients who received OMT, and the protocol was also safe regarding labor 
and delivery outcomes. OMT did not Increase the risk of precipitous labor, c-section or operative 
vaginal delivery. There was also no increase in need for episiotomy, incidence of perineal 
laceration or meconium fluid when compared to the usual care or the usual care plus placebo 
groups. Interestingly, the OMT group was 2.3 times more likely to experience prolonged labor 
when compared to the participants of the usual care group and 4 times more likely to 
experience prolonged labor when compared to the participants in the usual care plus placebo. It 
is important to note that the difference in labor durations were not statistically significant in 
relation to any of the safety outcomes (Hansel et al). 
A prospective study was completed in 2019, looking at the effects of OMT on the duration of 
labor in the inpatient setting (Martingano et al). In this study 100 patients were enrolled, with 50 
receiving adjunct OMT along with standard labor management from osteopathic physicians. 
These patients were matched to 50 control patients, who received standard labor management 
alone from allopathic physicians. Patients in the OMT group were treated once daily with a 
standardized protocol including: suboccipital decompression, thoracic inlet release, rib raising, 
paraspinal inhibition, and sacral inhibition. Every OMT patient received every treatment each 
day that they were admitted. The study looked at labor duration, meconium fluid, and 
conversion to a c-section due to failure to progress or lack of descent. All 100 patients in this 
study received an epidural and oxytocin augmentation of labor. The average duration of labor 
for controls was 16.57 hours versus 11.34 hours in the OMT group (Martingano et al). These 
results are in direct contradiction with the former retrospective study completed by Hansel et al 
in 2016. 

Case Study Protocol 
Background: 
a. Previous research as described in above literature review 
b. Does OMT in the 3rd trimester of pregnancy shorten duration of labor? 
c. Does OMT in the 3rd trimester of pregnancy reduce risk of perineal laceration, 
meconium fluid, operative vaginal delivery, or conversion to c-section? 
d. Does OMT in the 3rd trimester of pregnancy reduce analgesic use during labor? 
Design: 
a. Pregnant patients who are 34 weeks to delivery will be recruited through Southwest 
Michigan Women’s Clinic and Cass Community Clinic in Niles, Intercare (Benton 
Harbor), South Shore Women’s Health (Saint Joseph), and BellaNova (Saint Joseph, 
MI), using referrals and flyers distributed by providers in those offices 
b. Patients who wish to participate will call the Longmeadow Primary Care Clinic (number 
listed on flyer) to schedule an appointment. 
c. Participants must discuss their participation in the study with their obstetrical provider 
and provide a signed information brochure at their first appointment. Signed brochures 
will be scanned into the patient’s chart. 
d. Patients will be consented using a tablet in the lobby of the Longmeadow Primary Care 
Residency Clinic or with Rachelle Pichot, consent form attached 
e. If patients have questions about OMT or the study, they will be directed to call the 
Longmeadow Primary Care Clinic where office staff will be knowledgeable in where to 
direct the call. Attending DO physicians or participating DO resident physicians will 
return calls to answer those questions. 
f. OMT will be performed by Drs Schaefer, Moreno, Mather, Collingsworth, Gutierrez, and 
Pearson based on patient’s structural exam in relation to the evaluation list below. 
Additional senior level residents may be included in OMT treatments as the study 
progresses and more participants wish to join. OMT is performed regularly by all DO 
providers at the Longmeadow Primary Care Residency Clinic. 
g. Appointments will be blocked specifically for study participants 
h. Study participants will not be charged for these appointments 
i. 
Patients will receive once weekly treatments from 34 weeks gestation until delivery. 
Minimum of one OMT treatment is needed to be included in the study. 
j. 
Exam and treatments to focus on areas commonly affecting pregnant women 
i. 
Evaluation to include: 
1. Chapman points for uterus and broad ligament 
2. Evaluation and treatment of the occiput using soft tissue and muscle 
energy techniques 
3. Evaluation and treatment of the thoracic inlet using myofascial release 
technique 

4. Evaluation and treatment of the ribs using muscle energy and counter-
strain techniques 
5. Evaluation and treatment of the paraspinal musculature using soft tissue 
and muscle energy techniques 
6. Evaluation and treatment of the sacrum using muscle energy and 
articulatory techniques 
k. The control group will be all patients who give birth at Corewell Health – South for the 
duration of the study per the HIPAA Waiver of Informed Consent. 
l. 
There will be no follow-up with the participants in the study, all data will be gathered with 
epic, no identifying information will be shared, and patients will not be contacted past 
their delivery date. 
Case Inclusion: 
a. Pregnant patients, ages 18-34 
b. Primiparous and multiparous 
c. Gestational age ≥34 weeks 
d. Delivering at Corewell Health South Saint Joseph or Niles hospitals 
e. Consent for treatment or as a control 
f. English or Spanish speaker 
Case Exclusion: 
a. Absolute contraindications to OMT 
b. Acute abdomen 
c. BP >160/110 
d. Unexplained visual disturbances 
e. Heavy vaginal bleeding preceding delivery 
f. <34 weeks gestational age 
g. Treatment refusal 
h. Magnesium sulfate received for seizure prophylaxis in setting of preeclampsia w/ severe 
features or severe gestational HTN 
i. 
Scheduled c-section due to prior OB conditions 
Data Collection: 
a. data to be collected via EPIC charting completed by nurse and obstetrical provider 
i. 
maternal age 
ii. 
parity 
iii. 
gestational age 
iv. 
number of OMT treatments received 
v. 
Types of OMT treatments recieved 
vi. 
preterm delivery before 37 weeks (if applicable) 
vii. 
duration of labor 
viii. 
meconium amniotic fluid 

ix. 
perineal laceration occurrence and degree 
x. 
epidural and other analgesic use 
xi. 
need for operative vaginal delivery 
xii. 
need for conversion to c-section 
xiii. 
APGAR scores 
b. Data will only be available to primary and secondary investigators 
c. Data will be stored in a password protected excel sheet on a protected server 
d. Identifying data will not be shared or used in future write ups 
Data Analysis: 
Unknown at this time, dependent on available software and data 
Study Limitations: 
a. Propensity of OB providers to convert to CS/OVD 
b. Patient preference for OMT/experience with OMT 
c. Age of patient 
d. Pre-existing physical activity may change outcomes and participation 
e. Body habitus 
f. Limited number of patients in study 
g. Protections in vulnerable patient population 
Ethical Considerations: 
Benefits: (Carnes, Mars et al. 2010) 
● Reduced pain 
● Increased mobility 
● Reduced lower extremity swelling 
● Decreased health care cost 
Risks: (Carnes, Mars et al. 2010) 
● Increased muscle soreness following treatment- short term, minimal severity, diminished 
in days 
● Localized tenderness/stiffness 
● Headaches 
Absolute Contraindications: (Carnes, Mars et al. 2010) 
General issues 
1. No permission given by patient 
2. Contraindications have not been established 
3. No thorough medical history and physical examination have been conducted 

General Medical Conditions 
1. Patient has an underlying medical/surgical emergency 
2. Acute abdominal pain 
3. Sudden unexplained nausea, vomiting or diarrhea 
Cardiovascular disorders 
1. Hypertensive crisis with BP >190/110 bpm 
2. Tendency to collapse (low BP, low BMI) 
3. Untreated cardiac insufficiency and arrhythmia 
Neurological/Neurovascular disorders 
1. Suspected vascular occlusions 
2. Acute, intense headache 
3. Acute neck stiffness 
4. Strong unexplained vertigo 
5. Acute paresthesia/paralysis 
6. Cauda-Equina Syndrome 
7. Sudden visual disturbances 
Obstetric & Gynecological disorders 
1. Symptoms that risk fetal loss such as contractions and vaginal bleeding 
2. Abnormal prenatal tests during pregnancy that OB deems unsuitable 
Psychiatric disorders 
1. Untreated psychosis 
2. Underage or mentally incompetent patients who are unable to give consent 
3. Post-traumatic stress 
4. Suicidal patients 
Adverse Event Reporting 
Adverse events that are non-serious will be reported in the Annual Report or Withdrawal of IND 
report to the FDA, and in the Continuing Review to the IRB. Serious or life-threatening adverse 
events directly attributable to the test article will be reported to the FDA and IRB in a prompt 
manner, based on IRB polciies. In general, a serious adverse event (SAE) will meet any of the 
following conditions: 
1) results in death; 
2) is life-threatening (places the subject at immediate risk of death from the event as it 
occurred); 

3) results in hospitalization or prolongation of existing hospitalization; 
4) results in persistent or significant disability/incapacity; 
5) results in a congenital anomaly or a birth defect; or 
6) based upon appropriate medical judgment, may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent a severe outcome. 
SAE reporting will be based on whether the SAE is possibly, probably or definitely related to the 
administration of this test article. Abnormal laboratory values will be reported if associated with a 
clinical abnormality. 
 
 

References 
“Osteopathic Manipulative Therapy & OMT.” Cleveland Clinic, 
my.clevelandclinic.org/health/treatments/9095-omt-osteopathic-manipulation-treatment. Accessed 4 Aug. 
2023. 
Bodine WA. Osteopathic Manipulative Treatment: A Primary Care Approach. Am Fam Physician. 2019 
Feb 15;99(4):214. PMID: 30763051. 
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; 
PMCID: PMC9143587. 
“C-Section (Cesarean Section): Procedure, Risks & Recovery.” C-Section, Cleavland Clinic, 
my.clevelandclinic.org/health/treatments/7246-cesarean-birth-c-section. Accessed 5 Oct. 2023. 
“Forceps Delivery: What to Expect, Risks & Recovery - Cleveland Clinic.” Forceps Delivery, Cleavland 
Clinic, my.clevelandclinic.org/health/treatments/23260-forceps-delivery. Accessed 5 Oct. 2023. 
“Vacuum Extraction Delivery: What to Expect & Side Effects.” Vacuum Extraction Delivery, Cleavland 
Clinic, my.clevelandclinic.org/health/treatments/22305-vacuum-extraction-delivery. Accessed 5 Oct. 2023. 
King HH, Tettambel MA, Lockwood MD, Johnson KH, Arsenault DA, Quist R. Osteopathic Manipulative 
Treatment in Prenatal Care: A Retrospective Case Control Design Study. JAOA. 2003;103(12):577-582. 
Lavelle JM. Osteopathic Manipulative Treatment in Pregnant Women. The Journal of the American 
Osteopathic Association. 2012;112(6):343. doi:https://doi.org/10.7556/jaoa.2012.112.6.343 
Ruffini N, D’Alessandro G, Cardinali L, Frondaroli F, Cerritelli F. Osteopathic manipulative treatment in 
gynecology and obstetrics: A systematic review. Complementary Therapies in Medicine. 2016;26:72-78. 
doi:https://doi.org/10.1016/j.ctim.2016.03.005 
Hensel KL, Roane BM, Chaphekar AV, Smith-Barbaro P. PROMOTE Study: Safety of Osteopathic 
Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes. The Journal of the 
American Osteopathic Association. 2016;116(11):698. doi:https://doi.org/10.7556/jaoa.2016.140 
Martingano D, Ho S, Rogoff S, Chang G, Aglialoro GC. Effect of Osteopathic Obstetrical Management on 
the Duration of Labor in the Inpatient Setting: A Prospective Study and Literature Review. The Journal of 
the American Osteopathic Association. 2019;119(6):371. doi:https://doi.org/10.7556/jaoa.2019.066 
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.