Cesarean Rate in Parturients Without Neuraxial Analgesia
CRINA
Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
2 other identifiers
interventional
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 27, 2011
July 1, 2011
1 year
July 6, 2010
July 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cesarean rate
Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women
One day after birth
Secondary Outcomes (9)
Instrumental delivery
One day after birth
VAS pain intensity
At the begining of labor (0 min)
VAS pain intensity
At the cervix 10 cm (This time may be subjected to change in different patients)
VAS pain intensity
2h after cervix 10 cm
Time of successful labor
From the initial of labor (0 min) to completion of delivery (this is changable individually)
- +4 more secondary outcomes
Study Arms (2)
Non-neuraxial analgesia
ACTIVE COMPARATORParturients will not receive neuraxial analgesia
Neuraxial analgesia
ACTIVE COMPARATORParturients will receive neuraxial analgesia
Interventions
Neuraxial analgesia will be given at any time if the parturient requested analgesia
No neuraxial analgesia will be given to those who will not want to an analgesia
Eligibility Criteria
You may qualify if:
- Age \>= 19yr, \<=40 yr
- Height 140 - 170 cm
- Singleton pregnancy
- Uncomplicated pregnancy
- Chinese
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
Study Officials
- STUDY DIRECTOR
XiaoFeng Shen, MD, MPH
Nanjing Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 7, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 27, 2011
Record last verified: 2011-07