Cesarean Rate in Parturients Without Neuraxial Analgesia (CRINA)

Nanjing Medical University

Status: Completed

Conditions: Labor

Treatments: Procedure: Non-neuraxial analgesia; Procedure: Neuraxial analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01157325

NJMU10-201

NJFY2010Y116 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Non-neuraxial analgesia

Active Comparator group

Description:

Parturients will not receive neuraxial analgesia

Treatment:

Procedure: Non-neuraxial analgesia

Neuraxial analgesia

Active Comparator group

Description:

Parturients will receive neuraxial analgesia

Treatment:

Procedure: Neuraxial analgesia