Labor PainEACDRCDNCT00677274
Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
A study testing Epidural labor analgesia in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Epidural labor analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Aug 2008
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women
- > 18 years and < 45 years
- Spontaneous labor
- Analgesia request
Who cannot join
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- Those who were not willing to or could not finish the whole study at any time
- Using or used in the past 14 days of the monoamine oxidase inhibitors
- Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
- Subjects with a nonvertex presentation or scheduled induction of labor
Show all 9Show fewer
- Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
- Diagnosed diabetes mellitus and pregnancy-induced hypertension
- Twin gestation and breech presentation.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery
Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.
- Conditions
- Labor Pain
- Being tested
- Epidural labor analgesia
- Keywords
- Epidural analgesia, Patient-controlled analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the onset of regular uterine contraction
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 0.5cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 1.0cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 1.5cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 2.0cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 3.0cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 4.0cm
Epidural labor analgesiaProcedure or surgery
Also called Peridural analgesia
Epidural analgesia initiated at the cervix diameter 5.0cm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Epidural analgesia initiated at the cervix 0cm Receives: Procedure: Epidural labor analgesia |
| 2 | Active comparator | Epidural analgesia initiated at the cervix 0.5cm Receives: Procedure: Epidural labor analgesia |
| 3 | Active comparator | Epidural analgesia initiated at the cervix 1.0cm Receives: Procedure: Epidural labor analgesia |
| 4 | Active comparator | Epidural analgesia initiated at the cervix 1.5cm Receives: Procedure: Epidural labor analgesia |
| 5 | Active comparator | Epidural analgesia initiated at the cervix 2.0cm Receives: Procedure: Epidural labor analgesia |
| 6 | Active comparator | Epidural analgesia initiated at the cervix 3.0cm Receives: Procedure: Epidural labor analgesia |
| 7 | Active comparator | Epidural analgesia initiated at the cervix 4.0cm Receives: Procedure: Epidural labor analgesia |
| 8 | Active comparator | Epidural analgesia initiated at the cervix 5.0cm Receives: Procedure: Epidural labor analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cesarean delivery
Measured: 10 min after successful vaginal delivery
Secondary outcomes (16)
Rate of instrument-assisted delivery
Measured: 10 min after successful vaginal delivery
Indications of cesarean delivery
Measured: 10 min after cesarean section
Maternal Visual Analog Scale (VAS) rating of pain
Measured: 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery
Duration of analgesia
Measured: 0 min after analgesia to 15min after the disappearance of sensory block
Maternal satisfaction with analgesia
Measured: 30 min after the vaginal delivery
Maternal oral temperature
Measured: 0, 15, 30, 60, 120, 240, 480min after analgesia
Use of oxytocin after analgesia
Measured: 30 min after vaginal delivery
Maximal oxytocin dose
Measured: 30 min after vaginal delivery
Low back pain at 3 months after vaginal delivery
Measured: Three months after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Measured: Six weeks after successful delivery
Neonatal one-minute Apgar scale
Measured: 1 min after baby was born
Neonatal five-minute Apgar scale
Measured: Five min after baby was born
Umbilical-cord gases analysis
Measured: 0 min after baby was born
Neonatal sepsis evaluation
Measured: 30 min after baby was born
Neonatal antibiotic treatment
Measured: 1 week after baby was born
Incidence of maternal side effects
Measured: 1 week after successful vaginal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677274
- Sponsor's protocol ID
- NJFY-02028M03
- Other IDs
- NSR02970
- Acronym
- EACDRCD
- Status last verified
- Feb 2009
- First submitted
- 12 May 2008
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00677274
- Acronym / sponsor ID
- EACDRCD / NJFY-02028M03
- Conditions
- Labor Pain
- Keywords
- Epidural analgesia, Patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 May 2008 (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.
Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 0cm |
| 2 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 0.5cm |
| 3 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 1.0cm |
| 4 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 1.5cm |
| 5 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 2.0cm |
| 6 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 3.0cm |
| 7 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 4.0cm |
| 8 | Active comparator | Procedure: Epidural labor analgesiaEpidural analgesia initiated at the cervix 5.0cm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous women
- > 18 years and < 45 years
- Spontaneous labor
- Analgesia request
Key exclusion criteria (9 listed)
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- Those who were not willing to or could not finish the whole study at any time
- Using or used in the past 14 days of the monoamine oxidase inhibitors
- Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
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 |
|---|---|---|
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the onset of regular uterine contraction | Procedure or surgery | 1 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 0.5cm | Procedure or surgery | 2 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 1.0cm | Procedure or surgery | 3 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 1.5cm | Procedure or surgery | 4 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 2.0cm | Procedure or surgery | 5 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 3.0cm | Procedure or surgery | 6 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 4.0cm | Procedure or surgery | 7 |
| Epidural labor analgesiaAlso: Peridural analgesiaEpidural analgesia initiated at the cervix diameter 5.0cm | Procedure or surgery | 8 |
Primary outcome
Rate of cesarean delivery
Time frame: 10 min after successful vaginal delivery
16 secondary outcomes
Rate of instrument-assisted delivery
Time frame: 10 min after successful vaginal delivery
Indications of cesarean delivery
Time frame: 10 min after cesarean section
Maternal Visual Analog Scale (VAS) rating of pain
Time frame: 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery
Duration of analgesia
Time frame: 0 min after analgesia to 15min after the disappearance of sensory block
Maternal satisfaction with analgesia
Time frame: 30 min after the vaginal delivery
Maternal oral temperature
Time frame: 0, 15, 30, 60, 120, 240, 480min after analgesia
Use of oxytocin after analgesia
Time frame: 30 min after vaginal delivery
Maximal oxytocin dose
Time frame: 30 min after vaginal delivery
Low back pain at 3 months after vaginal delivery
Time frame: Three months after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Time frame: Six weeks after successful delivery
Neonatal one-minute Apgar scale
Time frame: 1 min after baby was born
Neonatal five-minute Apgar scale
Time frame: Five min after baby was born
Umbilical-cord gases analysis
Time frame: 0 min after baby was born
Neonatal sepsis evaluation
Time frame: 30 min after baby was born
Neonatal antibiotic treatment
Time frame: 1 week after baby was born
Incidence of maternal side effects
Time frame: 1 week after successful vaginal delivery
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 12 Feb 2009.
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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 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 Epidural labor analgesia in people with Labor Pain, 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 4 inclusion and 9 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 12 Feb 2009. 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?
Rate of cesarean delivery (time frame: 10 min after successful vaginal delivery). 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 12 Feb 2009.