Clinical trial NCT00677274: Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
Official title: Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Epidural analgesia
Patient-controlled analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2008-05-14
Enrollment: 780
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Nulliparous women
2. \> 18 years and \< 45 years
3. Spontaneous labor
4. Analgesia request

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of cesarean delivery
timeFrame: 10 min after successful vaginal delivery
Secondary outcomes:
measure: Rate of instrument-assisted delivery
timeFrame: 10 min after successful vaginal delivery
measure: Indications of cesarean delivery
timeFrame: 10 min after cesarean section
measure: Maternal Visual Analog Scale (VAS) rating of pain
timeFrame: 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
measure: Duration of analgesia
timeFrame: 0 min after analgesia to 15min after the disappearance of sensory block
measure: Maternal satisfaction with analgesia
timeFrame: 30 min after the vaginal delivery
measure: Maternal oral temperature
timeFrame: 0, 15, 30, 60, 120, 240, 480min after analgesia
measure: Use of oxytocin after analgesia
timeFrame: 30 min after vaginal delivery
measure: Maximal oxytocin dose
timeFrame: 30 min after vaginal delivery
measure: Low back pain at 3 months after vaginal delivery
timeFrame: Three months after vaginal delivery
measure: Breastfeeding success at 6 weeks after vaginal delivery
timeFrame: Six weeks after successful delivery
measure: Neonatal one-minute Apgar scale
timeFrame: 1 min after baby was born
measure: Neonatal five-minute Apgar scale
timeFrame: Five min after baby was born
measure: Umbilical-cord gases analysis
timeFrame: 0 min after baby was born
measure: Neonatal sepsis evaluation
timeFrame: 30 min after baby was born
measure: Neonatal antibiotic treatment
timeFrame: 1 week after baby was born
measure: Incidence of maternal side effects
timeFrame: 1 week after successful vaginal delivery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: