Cesarean Rate in Parturients Without Neuraxial Analgesia (CRINA)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01157325
First received: July 6, 2010
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Labor
Procedure: Neuraxial analgesia
Procedure: Non-neuraxial analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Cesarean rate [ Time Frame: One day after birth ] [ Designated as safety issue: Yes ]
    Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women


Secondary Outcome Measures:
  • Instrumental delivery [ Time Frame: One day after birth ] [ Designated as safety issue: Yes ]
    The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women

  • VAS pain intensity [ Time Frame: At the begining of labor (0 min) ] [ Designated as safety issue: Yes ]
    Labor pain intensity assessed using visual analog scale (VAS)

  • VAS pain intensity [ Time Frame: At the cervix 10 cm (This time may be subjected to change in different patients) ] [ Designated as safety issue: Yes ]
    Labor pain intensity assessed using visual analog scale (VAS)

  • VAS pain intensity [ Time Frame: 2h after cervix 10 cm ] [ Designated as safety issue: Yes ]
    Labor pain intensity assessed using visual analog scale (VAS)

  • Time of successful labor [ Time Frame: From the initial of labor (0 min) to completion of delivery (this is changable individually) ] [ Designated as safety issue: No ]
    Labor duration in both neuraxial and non-neuraxial analgesia women

  • Time of the first stage of labor [ Time Frame: From initial of the labor to the cervix reached to 10 cm (Different in different patients) ] [ Designated as safety issue: No ]
    Duration of the first stage of labor

  • Time of second stage of labor [ Time Frame: From the cervix at 10 cm to successful delivery of the baby (this is changable individually) ] [ Designated as safety issue: No ]
    Duration of the second stage of labor

  • Overall feeling of satisfaction of the labor [ Time Frame: At the end of successful baby delivery (it is changable individually) ] [ Designated as safety issue: No ]
    Satisfaction assessed using a visual analog scale (VAS) at the end of the labor delivery

  • Side effects [ Time Frame: From the initial of labor (0 min) to the end of the labor (is is changable individually) ] [ Designated as safety issue: Yes ]
    Side effects recorded from the labor initiation to successful delivery


Enrollment: 500
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01157325

Locations
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD, MPH Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01157325     History of Changes
Other Study ID Numbers: NJMU10-201, NJFY2010Y116
Study First Received: July 6, 2010
Last Updated: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Epidural analgesia
Latent analgesia
Active analgesia
Cesarean section

ClinicalTrials.gov processed this record on October 01, 2014