Cesarean Rate in Parturients Without Neuraxial Analgesia (CRINA)

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

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.

Study Overview

• Status: Completed
• Conditions: Labor
• Intervention / Treatment: Procedure: Non-neuraxial analgesia; Procedure: Neuraxial analgesia

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-neuraxial analgesia; Parturients will not receive neuraxial analgesia	Procedure: Non-neuraxial analgesia; No neuraxial analgesia will be given to those who will not want to an analgesia
Active Comparator: Neuraxial analgesia; Parturients will receive neuraxial analgesia	Procedure: Neuraxial analgesia; Neuraxial analgesia will be given at any time if the parturient requested analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean rate	Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women	One day after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumental delivery	The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women	One day after birth
VAS pain intensity	Labor pain intensity assessed using visual analog scale (VAS)	At the begining of labor (0 min)
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)
VAS pain intensity	Labor pain intensity assessed using visual analog scale (VAS)	2h after cervix 10 cm
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: XiaoFeng Shen, MD, MPH, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2011
• Last Update Submitted That Met QC Criteria: July 26, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Epidural analgesia; Cesarean section; Latent analgesia; Active analgesia
• Other Study ID Numbers: NJMU10-201; NJFY2010Y116 (Other Grant/Funding Number: Nanjing Maternity and Child Health Care Hospital)