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Prolonged LaborPhase 2/3NCT02334150

Epidural Analgesia on Electrophysiological Function

A Phase 2/3 study testing CSEA (ropivocaine and sufentanil) in people with Prolonged Labor and Healthy, run by Nanjing Maternity and Child Health Care Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Prolonged Labor, Healthy, Pelvic Floor Disorders
What is being tested?
CSEA (ropivocaine and sufentanil)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
1 siteChina
Study dates
Jun 2013to Sep 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Maternal and Child Health Hospital of Nanning City

    Nanning, Guangxi, 530021

Other trials in China

About this study

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

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.

Read the 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.

Being tested
CSEA (ropivocaine and sufentanil)
Keywords
combined spinal-epidural analgesia, pelvic floor muscle, postpartum electrophysiological function
Medical subject headings
Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSEA (ropivocaine and sufentanil)Drug

    Also called Combined spinal-epidural analgesia

    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.

Study groups in NCT02334150
Study groupRoleWhat they receive
CSEA groupExperimentalWomen 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.
Receives: Drug: CSEA (ropivocaine and sufentanil)
Control groupNo interventionWomen in the control group were not provided any analgesia during labor.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (2)

  1. Degrees of muscle fatigue

    Degree of muscle fatigue was considered normal if 0%, abnormal if <0%.

    Measured: 6 weeks

  2. The distribution of pelvic floor dynamic pressures

    Pelvic floor dynamic pressure was considered normal when it fell between 80 and 150 cm H2O.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334150
Sponsor's protocol ID
NanningMCH
Other IDs
Ji-Juan Xing
Status last verified
Jan 2015
First submitted
31 Dec 2014
Last updated
8 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16205845

  • 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.

    PubMed 20920070

  • 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.

    PubMed 26340002

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CSEA (ropivocaine and sufentanil) in people with Prolonged Labor and Healthy, run by Nanjing Maternity and Child Health Care Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02334150, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.

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