Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Cesarean rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >= 19yr, <=40 yr
- •Height 140 - 170 cm
- •Singleton pregnancy
- •Uncomplicated pregnancy
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
Outcomes
Primary Outcomes
Cesarean rate
Time Frame: One day after birth
Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women
Secondary Outcomes
- Instrumental delivery(One day after birth)
- 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))
- Time of the first stage of labor(From initial of the labor to the cervix reached to 10 cm (Different in different patients))
- Time of second stage of labor(From the cervix at 10 cm to successful delivery of the baby (this is changable individually))
- Overall feeling of satisfaction of the labor(At the end of successful baby delivery (it is changable individually))
- Side effects(From the initial of labor (0 min) to the end of the labor (is is changable individually))