Epidural Analgesia on Electrophysiological Function

Healthy Clinical Trial

Official title:

Effects of Combined Spinal-epidural Analgesia During Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334150
• Other study ID #: NanningMCH
• Secondary ID: Ji-Juan Xing
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 31, 2014
• Last updated: January 7, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Nanjing Maternity and Child Health Care Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy
• Pelvic Floor Disorders
• Prolonged Labor

Intervention

Drug:
• CSEA (ropivocaine and sufentanil)
Women in the CSEA group received CSEA during labor. An intravenous line was established when the uterine opening measured 1-2 cm. Then sufentanil (5-7 µg) was injected intrathecally. When the visual analogue pain score was 3 or higher, a mixture of ropivocaine (0.143%) and sufentanil (0.3 µg/ml) was continuously infused into the epidural space using an analgesia pump until the cervix was fully dilated. Load capacity was 5 ml. The analgesic plane was controlled under T10.

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Nanning City	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 vagina — View Citation

Frawley HC, Galea MP, Phillips BA, Sherburn M, Bø K. Effect of test position on pelvic floor muscle assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):365-71. Epub 2005 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength scores	The postpartum strength of pelvic floor muscles was measured with subjects in the supine lithotomy position. A vaginal manometric probe with a balloon was sheathed with a condom and placed into the vagina; the top of the device lay at the bottom of the vagina before air inflation. The other side of the probe was connected to the PHENIX muscle stimulator. Muscle strength was assessed using the international muscle strength detection method, which features a strength scale from 0 to 5. The strength score depends on whether vaginal muscle contraction upon stimulation fails to occur (0 points) or lasts 1 second (1 point), 2 seconds (2 points) and so on. If the contraction lasts 5 seconds or more, a strength score of 5 is assigned.	6 weeks	No
Secondary	Degrees of muscle fatigue	Degree of muscle fatigue was considered normal if 0%, abnormal if <0%.	6 weeks	No
Secondary	The distribution of pelvic floor dynamic pressures	Pelvic floor dynamic pressure was considered normal when it fell between 80 and 150 cm H2O.	6 weeks	No