Cesarean Rate in Parturients Without Neuraxial Analgesia

Not Applicable

Completed

• Conditions: Labor
• Interventions: Procedure: Non-neuraxial analgesia; Procedure: Neuraxial analgesia

• Registration Number: NCT01157325
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-neuraxial analgesia	Non-neuraxial analgesia	Parturients will not receive neuraxial analgesia
Neuraxial analgesia	Neuraxial analgesia	Parturients will receive neuraxial analgesia

Primary Outcome Measures

Name	Time	Method
Cesarean rate	One day after birth	Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women

Secondary Outcome Measures

Name	Time	Method
Instrumental delivery	One day after birth	The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women
VAS pain intensity	2h after cervix 10 cm	Labor pain intensity assessed using visual analog scale (VAS)
Time of successful labor	From the initial of labor (0 min) to completion of delivery (this is changable individually)	Labor duration in both neuraxial and non-neuraxial analgesia women
Time of the first stage of labor	From initial of the labor to the cervix reached to 10 cm (Different in different patients)	Duration of the first stage of labor
Time of second stage of labor	From the cervix at 10 cm to successful delivery of the baby (this is changable individually)	Duration of the second stage of labor
Overall feeling of satisfaction of the labor	At the end of successful baby delivery (it is changable individually)	Satisfaction assessed using a visual analog scale (VAS) at the end of the labor delivery
Side effects	From the initial of labor (0 min) to the end of the labor (is is changable individually)	Side effects recorded from the labor initiation to successful delivery

Trial Locations

Locations (1)

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China