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

Labor Pain Clinical Trial

— EACDRCD  

Official title:

Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677274
• Other study ID #: NJFY-02028M03
• Secondary ID: NSR02970
• Status: Completed
• Phase: N/A
• First received: May 12, 2008
• Last updated: February 11, 2009
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: February 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• Epidural labor analgesia
Epidural analgesia initiated at the onset of regular uterine contraction
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 0.5cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.0cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.5cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 2.0cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 3.0cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 4.0cm
• Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 5.0cm

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cesarean delivery		10 min after successful vaginal delivery	Yes
Secondary	Rate of instrument-assisted delivery		10 min after successful vaginal delivery	Yes
Secondary	Indications of cesarean delivery		10 min after cesarean section	Yes
Secondary	Maternal Visual Analog Scale (VAS) rating of pain		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	Yes
Secondary	Duration of analgesia		0 min after analgesia to 15min after the disappearance of sensory block	Yes
Secondary	Maternal satisfaction with analgesia		30 min after the vaginal delivery	No
Secondary	Maternal oral temperature		0, 15, 30, 60, 120, 240, 480min after analgesia	Yes
Secondary	Use of oxytocin after analgesia		30 min after vaginal delivery	Yes
Secondary	Maximal oxytocin dose		30 min after vaginal delivery	No
Secondary	Low back pain at 3 months after vaginal delivery		Three months after vaginal delivery	Yes
Secondary	Breastfeeding success at 6 weeks after vaginal delivery		Six weeks after successful delivery	Yes
Secondary	Neonatal one-minute Apgar scale		1 min after baby was born	Yes
Secondary	Neonatal five-minute Apgar scale		Five min after baby was born	Yes
Secondary	Umbilical-cord gases analysis		0 min after baby was born	Yes
Secondary	Neonatal sepsis evaluation		30 min after baby was born	Yes
Secondary	Neonatal antibiotic treatment		1 week after baby was born	Yes
Secondary	Incidence of maternal side effects		1 week after successful vaginal delivery	Yes