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Completed

NCT Number: NCT01157325

Cesarean Rate in Parturients Without Neuraxial Analgesia

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.

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Key information

Conditions

Labor

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuraxial Analgesia

Procedure

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

Non-neuraxial analgesia

Procedure

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

Primary outcomes

  1. Cesarean rate

    Time frame: One day after birth

    Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women

Secondary outcomes

  1. Instrumental delivery

    Time frame: One day after birth

    The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women

  2. VAS pain intensity

    Time frame: At the begining of labor (0 min)

    Labor pain intensity assessed using visual analog scale (VAS)

  3. VAS pain intensity

    Time frame: At the cervix 10 cm (This time may be subjected to change in different patients)

    Labor pain intensity assessed using visual analog scale (VAS)

  4. VAS pain intensity

    Time frame: 2h after cervix 10 cm

    Labor pain intensity assessed using visual analog scale (VAS)

  5. Time of successful labor

    Time frame: 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

  6. Time of the first stage of labor

    Time frame: From initial of the labor to the cervix reached to 10 cm (Different in different patients)

    Duration of the first stage of labor

  7. Time of second stage of labor

    Time frame: From the cervix at 10 cm to successful delivery of the baby (this is changable individually)

    Duration of the second stage of labor

  8. Overall feeling of satisfaction of the labor

    Time frame: 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

  9. Side effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: CRINA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2010
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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