Clinical trial NCT02334150: Epidural Analgesia on Electrophysiological Function
Official title: Effects of Combined Spinal-epidural Analgesia During Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prolonged Labor
Healthy
Pelvic Floor Disorders
Keywords: combined spinal-epidural analgesia
pelvic floor muscle
postpartum electrophysiological function
Lead sponsor: Nanjing Maternity and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 308
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled trial examined whether CSEA affects the electrophysiological index of postpartum pelvic floor muscle during labor. The investigators plan to recruit 300 primiparous healthy women.

Detailed description: Labor analgesia can relieve labor pain, reduce stress reactions, and improve blood supply to the fetus, benefiting mother and baby. Though traditional epidural analgesia has been used for more than 40 years, combined spinal-epidural analgesia (CSEA) has become popular because it provides faster-onset pain relief with minimal motor weakness. CSEA may also accelerate cervical dilation.

Despite the popularity of CSEA, whether it is associated with short- or long-term beneficial or adverse effects on mothers remains unclear. One question is whether the procedure affects the risk of female pelvic floor disorder (PFD), in which the pelvic floor muscles are injured. These muscles are responsible for supporting the pelvic organs and for stabilizing them during the rhythmic, strong labor contractions and for the diaphragm to contract enough to generate pressures of up to 19 kPa. Numerous risk factors have been associated with PFD, including obesity, diabetes, older age, connective tissue disorder, neurological disease, pregnancy, vaginal delivery and childbirth. PFD can lead in turn to stress urinary incontinence, overactive bladder, pelvic organ prolapse and fecal incontinence, all of which can strongly reduce women's physical and psychological health.

Pelvic floor function can be analyzed by measuring the strength and degree of fatigue of pelvic floor muscles, as well as the pelvic dynamic pressure. Abnormalities in these indicators appear even before patients complain of the signs and symptoms of PFD, making them a useful early diagnostic index.

In this randomized controlled study, we examined whether CSEA affects postpartum pelvic floor muscle function in primiparous mothers who give birth vaginally, as well as the duration of different stages of labor. Our results should help establish whether the widespread use of CSEA provides benefits to mothers or poses a risk.

Eligibility criteria: Inclusion Criteria:

* Primiparous women gave birth by vaginal delivery between June 2013 and June 2014 in the Maternal and Child Health Hospital of Nanning
* They were 22-30 years old
* They were 155-165 cm tall
* They were assigned a score of I or II on the American Society of Anesthesiologists scale
* They gave birth by vaginal delivery to a live, single, mature fetus (≥ 38, ≤ 40 w) in the head position
* A neonatal weight of 2900-3500 g

Exclusion Criteria:

* History of chronic cough
* Chronic constipation or pelvic organ resection
* Family history of urinary incontinence
* Pelvic organ prolapsus
* Any systemic disease before delivery
* A history of surgery, trauma, tumors or deformity of lumbar vertebrae

Primary outcomes:
measure: Muscle strength scores
timeFrame: 6 weeks
Secondary outcomes:
measure: Degrees of muscle fatigue
timeFrame: 6 weeks
measure: The distribution of pelvic floor dynamic pressures
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nanning
country: China
facility: Maternal and Child Health Hospital of Nanning City
state: Guangxi
Study officials:
affiliation: Maternal and Child Health Hospital of Nanning City
name: Ji-Juan Xing
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frawley HC, Galea MP, Phillips BA, Sherburn M, Bo K. Effect of test position on pelvic floor muscle assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):365-71. doi: 10.1007/s00192-005-0016-3. Epub 2005 Oct 5.
citation: Caroci Ade S, Riesco ML, Sousa Wda S, Cotrim AC, Sena EM, Rocha NL, Fontes CN. Analysis of pelvic floor musculature function during pregnancy and postpartum: a cohort study: (a prospective cohort study to assess the PFMS by perineometry and digital vaginal palpation during pregnancy and following vaginal or caesarean childbirth). J Clin Nurs. 2010 Sep;19(17-18):2424-33. doi: 10.1111/j.1365-2702.2010.03289.x.
citation: Xing JJ, Liu XF, Xiong XM, Huang L, Lao CY, Yang M, Gao S, Huang QY, Yang W, Zhu YF, Zhang DH. Effects of Combined Spinal-Epidural Analgesia during Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: A Randomized Controlled Trial. PLoS One. 2015 Sep 4;10(9):e0137267. doi: 10.1371/journal.pone.0137267. eCollection 2015.