LaborCRINANCT01157325
Cesarean Rate in Parturients Without Neuraxial Analgesia
A study testing Neuraxial analgesia and Non-neuraxial analgesia in people with Labor, run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Labor
- What is being tested?
- Neuraxial analgesia and Non-neuraxial analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age >= 19yr, <=40 yr
- Height 140 - 170 cm
- Singleton pregnancy
- Uncomplicated pregnancy
- Chinese
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
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.
- Conditions
- Labor
- Being tested
- Neuraxial analgesia, Non-neuraxial analgesia
- Keywords
- Epidural analgesia, Latent analgesia, Active analgesia, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraxial analgesiaProcedure or surgery
Neuraxial analgesia will be given at any time if the parturient requested analgesia
Non-neuraxial analgesiaProcedure or surgery
No neuraxial analgesia will be given to those who will not want to an analgesia
| Study group | Role | What they receive |
|---|---|---|
| Non-neuraxial analgesia | Active comparator | Parturients will not receive neuraxial analgesia Receives: Procedure: Non-neuraxial analgesia |
| Neuraxial analgesia | Active comparator | Parturients will receive neuraxial analgesia Receives: Procedure: Neuraxial analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean rate
Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women
Measured: One day after birth
Secondary outcomes (9)
Instrumental delivery
The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women
Measured: One day after birth
VAS pain intensity
Labor pain intensity assessed using visual analog scale (VAS)
Measured: At the begining of labor (0 min)
VAS pain intensity
Labor pain intensity assessed using visual analog scale (VAS)
Measured: At the cervix 10 cm (This time may be subjected to change in different patients)
VAS pain intensity
Labor pain intensity assessed using visual analog scale (VAS)
Measured: 2h after cervix 10 cm
Time of successful labor
Labor duration in both neuraxial and non-neuraxial analgesia women
Measured: From the initial of labor (0 min) to completion of delivery (this is changable individually)
Time of the first stage of labor
Duration of the first stage of labor
Measured: From initial of the labor to the cervix reached to 10 cm (Different in different patients)
Time of second stage of labor
Duration of the second stage of labor
Measured: From the cervix at 10 cm to successful delivery of the baby (this is changable individually)
Overall feeling of satisfaction of the labor
Satisfaction assessed using a visual analog scale (VAS) at the end of the labor delivery
Measured: At the end of successful baby delivery (it is changable individually)
Side effects
Side effects recorded from the labor initiation to successful delivery
Measured: From the initial of labor (0 min) to the end of the labor (is is changable individually)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, MPH, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157325
- Sponsor's protocol ID
- NJMU10-201
- Other IDs
- NJFY2010Y116
- Acronym
- CRINA
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2010
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
- ClinicalTrials.gov ID
- NCT01157325
- Acronym / sponsor ID
- CRINA / NJMU10-201
- Conditions
- Labor
- Keywords
- Epidural analgesia, Latent analgesia, Active analgesia, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-neuraxial analgesia | Active comparator | Procedure: Non-neuraxial analgesiaParturients will not receive neuraxial analgesia |
| Neuraxial analgesia | Active comparator | Procedure: Neuraxial analgesiaParturients will receive neuraxial analgesia |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age >= 19yr, <=40 yr
- Height 140 - 170 cm
- Singleton pregnancy
- Uncomplicated pregnancy
- Chinese
Key exclusion criteria (8 listed)
- Multiple gestations
- Pregnancy-induced hypertension
- Diabetes mellitus
- Chronic pain
- Allergic to opioids and/or local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuraxial analgesiaNeuraxial analgesia will be given at any time if the parturient requested analgesia | Procedure or surgery | Neuraxial analgesia |
| Non-neuraxial analgesiaNo neuraxial analgesia will be given to those who will not want to an analgesia | Procedure or surgery | Non-neuraxial analgesia |
Primary outcome
Cesarean rate
Time frame: One day after birth
Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women
9 secondary outcomes
Instrumental delivery
Time frame: One day after birth
VAS pain intensity
Time frame: At the begining of labor (0 min)
VAS pain intensity
Time frame: At the cervix 10 cm (This time may be subjected to change in different patients)
VAS pain intensity
Time frame: 2h after cervix 10 cm
Time of successful labor
Time frame: From the initial of labor (0 min) to completion of delivery (this is changable individually)
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)
Time of second stage of labor
Time frame: From the cervix at 10 cm to successful delivery of the baby (this is changable individually)
Overall feeling of satisfaction of the labor
Time frame: At the end of successful baby delivery (it is changable individually)
Side effects
Time frame: From the initial of labor (0 min) to the end of the labor (is is changable individually)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD, MPH study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuraxial analgesia and Non-neuraxial analgesia in people with Labor, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean rate (time frame: One day after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.