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Epidural Analgesia on Electrophysiological Function

Primary Purpose

Prolonged Labor, Healthy, Pelvic Floor Disorders

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CSEA (ropivocaine and sufentanil)
Sponsored by
Nanjing Maternity and Child Health Care Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prolonged Labor focused on measuring combined spinal-epidural analgesia, pelvic floor muscle, postpartum electrophysiological function

Eligibility Criteria

22 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maternal and Child Health Hospital of Nanning City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CSEA group

Control group

Arm Description

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.

Women in the control group were not provided any analgesia during labor.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Degrees of muscle fatigue
Degree of muscle fatigue was considered normal if 0%, abnormal if <0%.
The distribution of pelvic floor dynamic pressures
Pelvic floor dynamic pressure was considered normal when it fell between 80 and 150 cm H2O.

Full Information

First Posted
December 31, 2014
Last Updated
January 7, 2015
Sponsor
Nanjing Maternity and Child Health Care Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02334150
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Maternity and Child Health Care Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Labor, Healthy, Pelvic Floor Disorders
Keywords
combined spinal-epidural analgesia, pelvic floor muscle, postpartum electrophysiological function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSEA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women in the control group were not provided any analgesia during labor.
Intervention Type
Drug
Intervention Name(s)
CSEA (ropivocaine and sufentanil)
Other Intervention Name(s)
Combined spinal-epidural analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength scores
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Degrees of muscle fatigue
Description
Degree of muscle fatigue was considered normal if 0%, abnormal if <0%.
Time Frame
6 weeks
Title
The distribution of pelvic floor dynamic pressures
Description
Pelvic floor dynamic pressure was considered normal when it fell between 80 and 150 cm H2O.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Juan Xing
Organizational Affiliation
Maternal and Child Health Hospital of Nanning City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Nanning City
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16205845
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.
Results Reference
background
PubMed Identifier
20920070
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.
Results Reference
result
PubMed Identifier
26340002
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.
Results Reference
derived

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Epidural Analgesia on Electrophysiological Function

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