This study involves analysis of labor and delivery data collected during the PROMOTE study, which was conducted from 2007 to 2011. The PROMOTE study was funded by the National Institutes of Health and was a randomized controlled clinical trial that measured the primary outcomes of back-specific functioning and pain in pregnant women aged 18 to 34 years. This study was approved by the institutional review board at the University of North Texas Health Science Center. Participants were randomly divided into 3 groups—usual obstetric care only (UCO), placebo ultrasound treatment (PUT) plus usual obstetric care, and OMT plus usual obstetric care.
Study participants were scheduled for 7 treatment visits at 30, 32, 34, 36, 37, 38, and 39 weeks of gestation. The OMT and PUT visits lasted approximately 20 minutes. The OMT group received a protocol treatment that included all of the following techniques: seated thoracic articulation, cervical soft tissue, occipitoatlantal decompression, thoracic inlet myofascial release, lateral recumbent scapulothoracic soft tissue, lateral recumbent lumbar soft tissue, abdominal diaphragm myofascial release, pelvic diaphragm myofascial release, sacroiliac articulation, pubic symphysis decompression, frog-leg sacral release, and CV4. Thus, all OMT group participants received CV4. A detailed description of the protocol was previously published.
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In the PUT group, an ultrasound wand that did not emit any ultrasound waves was applied in similar areas as the OMT techniques. The PUT protocol was performed by the same treating physicians as the OMT protocol and lasted approximately the same amount of time. The UCO group had no treatment performed.
Labor and delivery data points were collected from medical records from the hospital birth location. Data points collected included length of labor, use of episiotomy, degree of perineal laceration, fever in mother during labor, characteristics of amniotic fluid (eg, meconium stained, bloody, clear), use of forceps, use of vacuum device, and Apgar scores. High-risk conditions that occurred during pregnancy were also collected, including gestational hypertension, gestational diabetes, preterm labor, preeclampsia, eclampsia, and oligohydramnios, among others.