CompletedNCT00677274EACDRCDUpdated Feb 12, 2009

Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery

An interventional study of Epidural labor analgesia and Epidural labor analgesia in Labor Pain, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-02-12.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 780
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Female

Study summary

Epidural analgesia in the early stage of labor at cervix \< 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.

Conditions studied

Labor Pain

Browse trials for

Labor Pain 396

Keywords

Epidural analgesia
Patient-controlled analgesia

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 780 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Nulliparous women
> 18 years and \< 45 years
Spontaneous labor
Analgesia request

Exclusion criteria

Exclusion Criteria:

Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
Participants younger than 18 years or older than 45 years
Those who were not willing to or could not finish the whole study at any time
Using or used in the past 14 days of the monoamine oxidase inhibitors
Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
Subjects with a nonvertex presentation or scheduled induction of labor
Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
Diagnosed diabetes mellitus and pregnancy-induced hypertension
Twin gestation and breech presentation.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 780 participants (actual)

Study arms

Active comparator
1
Epidural analgesia initiated at the cervix 0cm
Procedure: Epidural labor analgesia
Active comparator
2
Epidural analgesia initiated at the cervix 0.5cm
Procedure: Epidural labor analgesia
Active comparator
3
Epidural analgesia initiated at the cervix 1.0cm
Procedure: Epidural labor analgesia
Active comparator
4
Epidural analgesia initiated at the cervix 1.5cm
Procedure: Epidural labor analgesia
Active comparator
5
Epidural analgesia initiated at the cervix 2.0cm
Procedure: Epidural labor analgesia
Active comparator
6
Epidural analgesia initiated at the cervix 3.0cm
Procedure: Epidural labor analgesia
Active comparator
7
Epidural analgesia initiated at the cervix 4.0cm
Procedure: Epidural labor analgesia
Active comparator
8
Epidural analgesia initiated at the cervix 5.0cm
Procedure: Epidural labor analgesia

Interventions

ProcedureEpidural labor analgesia
Epidural analgesia initiated at the onset of regular uterine contraction
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 0.5cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.0cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.5cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 2.0cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 3.0cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 4.0cm
Also known as: Peridural analgesia
ProcedureEpidural labor analgesia
Epidural analgesia initiated at the cervix diameter 5.0cm
Also known as: Peridural analgesia

What researchers measure

Primary outcomes

Rate of cesarean delivery
Time frame: 10 min after successful vaginal delivery

Secondary outcomes

Rate of instrument-assisted delivery
Time frame: 10 min after successful vaginal delivery
Indications of cesarean delivery
Time frame: 10 min after cesarean section
Maternal Visual Analog Scale (VAS) rating of pain
Time frame: 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery
Duration of analgesia
Time frame: 0 min after analgesia to 15min after the disappearance of sensory block
Maternal satisfaction with analgesia
Time frame: 30 min after the vaginal delivery
Maternal oral temperature
Time frame: 0, 15, 30, 60, 120, 240, 480min after analgesia
Use of oxytocin after analgesia
Time frame: 30 min after vaginal delivery
Maximal oxytocin dose
Time frame: 30 min after vaginal delivery
Low back pain at 3 months after vaginal delivery
Time frame: Three months after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Time frame: Six weeks after successful delivery
Neonatal one-minute Apgar scale
Time frame: 1 min after baby was born
Neonatal five-minute Apgar scale
Time frame: Five min after baby was born
Umbilical-cord gases analysis
Time frame: 0 min after baby was born
Neonatal sepsis evaluation
Time frame: 30 min after baby was born
Neonatal antibiotic treatment
Time frame: 1 week after baby was born
Incidence of maternal side effects
Time frame: 1 week after successful vaginal delivery

Study locations

1 site

Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu 210004, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00677274
Lead sponsor: Nanjing Medical University
Collaborators: HRSA/Maternal and Child Health Bureau
First posted: May 14, 2008
Start date: May 2008
Primary completion: Aug 2008
Completion: Aug 2008
Last update: Feb 12, 2009

Study contacts

XiaoFeng Shen, MD

study director · Nanjing Medical University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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