Skip to content

Cesarean Rate in Parturients Without Neuraxial Analgesia

Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01157325
Acronym
CRINA
Enrollment
500
Registered
2010-07-07
Start date
2010-07-31
Completion date
2011-07-31
Last updated
2011-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor

Keywords

Epidural analgesia, Latent analgesia, Active analgesia, Cesarean section

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.

Interventions

Neuraxial analgesia will be given at any time if the parturient requested analgesia

PROCEDURENon-neuraxial analgesia

No neuraxial analgesia will be given to those who will not want to an analgesia

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cesarean rateOne day after birthRate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women

Secondary

MeasureTime frameDescription
Instrumental deliveryOne day after birthThe rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women
VAS pain intensityAt the begining of labor (0 min)Labor pain intensity assessed using visual analog scale (VAS)
Time of successful laborFrom 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 second stage of laborFrom 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 laborAt 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 effectsFrom 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
Time of the first stage of laborFrom initial of the labor to the cervix reached to 10 cm (Different in different patients)Duration of the first stage of labor

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026