Clinical trial NCT01157325: Cesarean Rate in Parturients Without Neuraxial Analgesia
Official title: Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Epidural analgesia
Latent analgesia
Active analgesia
Cesarean section
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cesarean rate
timeFrame: One day after birth
Secondary outcomes:
measure: Instrumental delivery
timeFrame: One day after birth
measure: VAS pain intensity
timeFrame: At the begining of labor (0 min)
measure: VAS pain intensity
timeFrame: At the cervix 10 cm (This time may be subjected to change in different patients)
measure: VAS pain intensity
timeFrame: 2h after cervix 10 cm
measure: Time of successful labor
timeFrame: From the initial of labor (0 min) to completion of delivery (this is changable individually)
measure: Time of the first stage of labor
timeFrame: From initial of the labor to the cervix reached to 10 cm (Different in different patients)
measure: Time of second stage of labor
timeFrame: From the cervix at 10 cm to successful delivery of the baby (this is changable individually)
measure: Overall feeling of satisfaction of the labor
timeFrame: At the end of successful baby delivery (it is changable individually)
measure: Side effects
timeFrame: From the initial of labor (0 min) to the end of the labor (is is changable individually)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD, MPH
role: STUDY_DIRECTOR
References: