NCT02334150

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

Completed Phase 2/Phase 3 Last updated 7 January 2015

What this trial tests

Phase 2/Phase 3 trial testing CSEA (ropivocaine and sufentanil) in Prolonged Labor in 308 participants. Completed in 1 September 2014.

Timeline

1 June 2013

Primary endpoint
1 June 2014

1 September 2014

Quick facts

Lead sponsor	Nanjing Maternity and Child Health Care Hospital
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	308
Start date	1 June 2013
Primary completion	1 June 2014
Estimated completion	1 September 2014
Sites	1 location across China

Drugs / interventions tested

• CSEA (ropivocaine and sufentanil) — full drug profile →

Conditions studied

• Prolonged Labor — all drugs for Prolonged Labor →
• Healthy — all drugs for Healthy →
• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

Nanjing Maternity and Child Health Care Hospital

Who can join

Adults 22 to 30, female only, with Prolonged Labor or Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Muscle strength scores
  Time frame: 6 weeks
  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 inte

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Combined Spinal-Epidural Analgesia during Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: A Randomized Controlled Trial.
   Xing JJ, Liu XF, Xiong XM, Huang L, et al · · 2015 · cited 13× · PMID 26340002 · DOI 10.1371/journal.pone.0137267