Cesarean Rate in Parturients Without Neuraxial Analgesia

Labor Clinical Trial

— CRINA  

Official title:

Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157325
• Other study ID #: NJMU10-201
• Secondary ID: NJFY2010Y116
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: July 26, 2011
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose not increase the risk of Cesarean section. However, given ethical reasons, whether such a medical procedure could increase the Cesarean rate compared with those who did not received neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in occidental countries because they have a higher rate of labor analgesia. On the contrary, the rate of labor analgesia in China is up to date only 1%, so it can be done easily. The investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean section. Therefore, the investigators design this study to compared the effect of neuraxial analgesia on the rate of Cesarean delivery with those who did not received neuraxial analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age >= 19yr, <=40 yr

• Height 140 - 170 cm

• Singleton pregnancy

• Uncomplicated pregnancy

• Chinese

Exclusion Criteria:

• Multiple gestations

• Pregnancy-induced hypertension

• Diabetes mellitus

• Chronic pain

• Allergic to opioids and/or local anesthetics

• Failed to performing inter lumbar space catheterization

• Organic dysfunction

• Contraindications for neuraxial analgesia

Study Design

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

Related Conditions & MeSH terms

• Labor

Intervention

Procedure:
• Neuraxial analgesia
Neuraxial analgesia will be given at any time if the parturient requested analgesia
• Non-neuraxial analgesia
No neuraxial analgesia will be given to those who will not want to an analgesia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean rate	Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women	One day after birth	Yes
Secondary	Instrumental delivery	The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women	One day after birth	Yes
Secondary	VAS pain intensity	Labor pain intensity assessed using visual analog scale (VAS)	At the begining of labor (0 min)	Yes
Secondary	VAS pain intensity	Labor pain intensity assessed using visual analog scale (VAS)	At the cervix 10 cm (This time may be subjected to change in different patients)	Yes
Secondary	VAS pain intensity	Labor pain intensity assessed using visual analog scale (VAS)	2h after cervix 10 cm	Yes
Secondary	Time of successful labor	Labor duration in both neuraxial and non-neuraxial analgesia women	From the initial of labor (0 min) to completion of delivery (this is changable individually)	No
Secondary	Time of the first stage of labor	Duration of the first stage of labor	From initial of the labor to the cervix reached to 10 cm (Different in different patients)	No
Secondary	Time of second stage of labor	Duration of the second stage of labor	From the cervix at 10 cm to successful delivery of the baby (this is changable individually)	No
Secondary	Overall feeling of satisfaction of the labor	Satisfaction assessed using a visual analog scale (VAS) at the end of the labor delivery	At the end of successful baby delivery (it is changable individually)	No
Secondary	Side effects	Side effects recorded from the labor initiation to successful delivery	From the initial of labor (0 min) to the end of the labor (is is changable individually)	Yes