Labor PainLALPNCT00647725
Labor Analgesia in the Latent Phrase
A study testing Active phrase epidural analgesia and Latent phrase epidural analgesia in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. 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?
- Active phrase epidural analgesia and Latent phrase epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2003to Dec 2007
- 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
- Nulliparas
- Required labor analgesia
- Chinese.
Who cannot join
- Allergic to opioids and/or local anesthetics
- Failed to performing epidural catheterization
- Organic dysfunction
- Contraindications for epidural analgesia.
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: Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery
Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore, we hypothesized that labor analgesia in the latent phrase of the first delivery stage would provide superior health care for laboring women. In addition, such analgesia technique would not prolong the time of uterine dilation and labor delivering.
- Conditions
- Labor Pain
- Being tested
- Active phrase epidural analgesia, Latent phrase epidural analgesia
- Keywords
- Epidural analgesia, Latent analgesia, Active analgesia, Labor delivery
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active phrase epidural analgesiaProcedure or surgery
Continuous epidural analgesia with sufentanil plus ropivacaine
Latent phrase epidural analgesiaProcedure or surgery
Continuous epidural analgesia with sufentanil plus ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Active phrase analgesia Receives: Procedure: Active phrase epidural analgesia |
| II | Active comparator | Latent phrase analgesia Receives: Procedure: Latent phrase epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cesarean delivery
Measured: The time of the end of the labor
Secondary outcomes (11)
Time of latent phrase
Measured: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm
Time of labor
Measured: From the beginning of regular contraction of uterus to the end of the labor
Overall feeling of satisfaction of analgesia
Measured: From the beginning of regular contraction of uterus to the end of the labor
Side effects
Measured: From the beginning of regular contraction of uterus to the end of the labor
VAS pain intensity
Measured: From the intinition of analgesia to the cervical dilation >4cm
Instrumental delivery
Measured: The end of the time of the labor
Oxytocin infusion rate
Measured: During the whole period of laboring
Neonatal Apgar scores
Measured: 1st min, 5th min, 10th min and 20th min
Umbilical gas measurement
Measured: After delivering of the fetus
Maternal oral temperature
Measured: From the initiation of analgesia to the end of the labor
Maternal corticosteroids
Measured: 1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647725
- Sponsor's protocol ID
- NMU-69714-14XS
- Other IDs
- MCH03552
- Acronym
- LALP
- Status last verified
- Sep 2009
- First submitted
- 28 Mar 2008
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang F, Shen X, Guo X, Peng Y, Gu X; Labor Analgesia Examining Group. Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology. 2009 Oct;111(4):871-80. doi: 10.1097/ALN.0b013e3181b55e65.
PubMed 19741492
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery
- ClinicalTrials.gov ID
- NCT00647725
- Acronym / sponsor ID
- LALP / NMU-69714-14XS
- Conditions
- Labor Pain
- Keywords
- Epidural analgesia, Latent analgesia, Active analgesia, Labor delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 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.
Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore, we hypothesized that labor analgesia in the latent phrase of the first delivery stage would provide superior health care for laboring women. In addition, such analgesia technique would not prolong the time of uterine dilation and labor delivering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: Active phrase epidural analgesiaActive phrase analgesia |
| II | Active comparator | Procedure: Latent phrase epidural analgesiaLatent phrase analgesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nulliparas
- Required labor analgesia
- Chinese.
Key exclusion criteria (4 listed)
- Allergic to opioids and/or local anesthetics
- Failed to performing epidural catheterization
- Organic dysfunction
- Contraindications for epidural analgesia.
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 |
|---|---|---|
| Active phrase epidural analgesiaContinuous epidural analgesia with sufentanil plus ropivacaine | Procedure or surgery | I |
| Latent phrase epidural analgesiaContinuous epidural analgesia with sufentanil plus ropivacaine | Procedure or surgery | II |
Primary outcome
Rate of Cesarean delivery
Time frame: The time of the end of the labor
11 secondary outcomes
Time of latent phrase
Time frame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm
Time of labor
Time frame: From the beginning of regular contraction of uterus to the end of the labor
Overall feeling of satisfaction of analgesia
Time frame: From the beginning of regular contraction of uterus to the end of the labor
Side effects
Time frame: From the beginning of regular contraction of uterus to the end of the labor
VAS pain intensity
Time frame: From the intinition of analgesia to the cervical dilation >4cm
Instrumental delivery
Time frame: The end of the time of the labor
Oxytocin infusion rate
Time frame: During the whole period of laboring
Neonatal Apgar scores
Time frame: 1st min, 5th min, 10th min and 20th min
Umbilical gas measurement
Time frame: After delivering of the fetus
Maternal oral temperature
Time frame: From the initiation of analgesia to the end of the labor
Maternal corticosteroids
Time frame: 1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor
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 1 Oct 2009.
- Results publication: PubMed 19741492Wang F, Shen X, Guo X, Peng Y, Gu X; Labor Analgesia Examining Group. Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology. 2009 Oct;111(4):871-80. doi: 10.1097/ALN.0b013e3181b55e65.
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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 Active phrase epidural analgesia and Latent phrase epidural 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 3 inclusion and 4 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 1 Oct 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: The time of the end of the labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647725, which also lists 1 linked publication.
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 1 Oct 2009.