Labor PainDCLEAPNCT00664118
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
A study testing Doula combined analgesia and Analgesia without doula in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. 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?
- Doula combined analgesia and Analgesia without doula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to May 2009
- 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
- Cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization
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: In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women
Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.
- Conditions
- Labor Pain
- Being tested
- Doula combined analgesia, Analgesia without doula
- Keywords
- Doula, Patient-controlled epidural analgesia, Neuraxial analgesia, Labor 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.
Doula combined analgesiaProcedure or surgery
Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas
Analgesia without doulaProcedure or surgery
Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Doula combined epidural analgesia in the latent phase of first stage of labor Receives: Procedure: Doula combined analgesia |
| 2 | Sham comparator | Epidural analgesia in the latent phase of the first stage of labor without doula accompany Receives: Procedure: Analgesia without doula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cesarean delivery
Measured: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)
Secondary outcomes (16)
Rate of instrumental delivery
Measured: Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)
Indications of cesarean delivery
Measured: Analgesia initiation (0 h) to cesarean section (4-7 h)
Maternal Visual Analog Scale (VAS) rating of pain
Measured: 15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery
Incidence of side effects
Measured: The whole period of the analgesia to successful vaginal delivery
Low back pain at 3 months after vaginal delivery
Measured: Three months after vaginal delivery
Maternal oral temperature
Measured: The whole period of the analgesia to successful vaginal delivery
Use of oxytocin after analgesia
Measured: During the whole period of the analgesia
Maximal oxytocin dose
Measured: 30 min after vaginal delivery
Duration of analgesia
Measured: Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)
Breastfeeding success at 6 weeks after vaginal delivery
Measured: Six weeks after successful delivery
Maternal satisfaction with analgesia
Measured: 30 min after the vaginal delivery
Neonatal one-minute Apgar scale
Measured: One minute after baby was born
Neonatal five-minute Apgar scale
Measured: Five minutes after baby was born
Umbilical-cord gases analysis
Measured: Immediately after baby was born
Neonatal sepsis evaluation
Measured: 5 min after the baby was born
Neonatal antibiotic treatment
Measured: 5 min after the baby was born
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT00664118
- Sponsor's protocol ID
- NMCHCH-0121-236
- Other IDs
- NMUC-08022
- Acronym
- DCLEAP
- Status last verified
- May 2009
- First submitted
- 18 Apr 2008
- Last updated
- 27 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women
- ClinicalTrials.gov ID
- NCT00664118
- Acronym / sponsor ID
- DCLEAP / NMCHCH-0121-236
- Conditions
- Labor Pain
- Keywords
- Doula, Patient-controlled epidural analgesia, Neuraxial analgesia, Labor analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Apr 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.
Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Doula combined analgesiaDoula combined epidural analgesia in the latent phase of first stage of labor |
| 2 | Sham comparator | Procedure: Analgesia without doulaEpidural analgesia in the latent phase of the first stage of labor without doula accompany |
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 (7 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 |
|---|---|---|
| Doula combined analgesiaDoula combined epidural analgesia in the latent phase of first stage of labor in primiparas | Procedure or surgery | 1 |
| Analgesia without doulaEpidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas | Procedure or surgery | 2 |
Primary outcome
Rate of cesarean delivery
Time frame: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)
16 secondary outcomes
Rate of instrumental delivery
Time frame: Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)
Indications of cesarean delivery
Time frame: Analgesia initiation (0 h) to cesarean section (4-7 h)
Maternal Visual Analog Scale (VAS) rating of pain
Time frame: 15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery
Incidence of side effects
Time frame: The whole period of the analgesia to successful vaginal delivery
Low back pain at 3 months after vaginal delivery
Time frame: Three months after vaginal delivery
Maternal oral temperature
Time frame: The whole period of the analgesia to successful vaginal delivery
Use of oxytocin after analgesia
Time frame: During the whole period of the analgesia
Maximal oxytocin dose
Time frame: 30 min after vaginal delivery
Duration of analgesia
Time frame: Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)
Breastfeeding success at 6 weeks after vaginal delivery
Time frame: Six weeks after successful delivery
Maternal satisfaction with analgesia
Time frame: 30 min after the vaginal delivery
Neonatal one-minute Apgar scale
Time frame: One minute after baby was born
Neonatal five-minute Apgar scale
Time frame: Five minutes after baby was born
Umbilical-cord gases analysis
Time frame: Immediately after baby was born
Neonatal sepsis evaluation
Time frame: 5 min after the baby was born
Neonatal antibiotic treatment
Time frame: 5 min after the baby was born
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 May 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 Doula combined analgesia and Analgesia without doula 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 7 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 May 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. Some participants in this study may receive a placebo. 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: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)). 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 May 2009.