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Labor PainPOPICNCT00776581

Ten-year Practice of Labor Pain Control in China

An observational study of Labor Pain, run by Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Since 1999, labor pain control has being performed in China, and the initial time of analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics \& Gynecology recommended that the labor analgesia with neuraxial block should be performed at the cervix >= 4 cm in 2002. 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?
CSEA with PCA, CSEA with IBI and EA with PCA
How many people
40,000 participants
Where
1 siteChina
Study dates
Jan 2009to Sep 2009
Phase
Observational
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

Study population: All parturients delivered in the investigator's institution since from January 1999 to December 2008

Who may be able to join

  • Parturients used labor analgesia

Who cannot join

  • Following criteria were based on the records of information received from the ten-year practice screened by investigators:
  • Chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • 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
  • 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

Other trials in China

About this study

Official title: A Ten-year Practice of Labor Pain Control in China

Since 1999, labor pain control has being performed in China, and the initial time of analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics \& Gynecology recommended that the labor analgesia with neuraxial block should be performed at the cervix >= 4 cm in 2002. After that, the threshold has been revised to at least >= 2 cm in 2006 by the Society. However, in China, the practice of labor analgesia with neuraxial block has being performed for over seven years. Up until now, the practice has being experienced during this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor pain control in different stages had different characteristics and had different influence on patients short- and long-lasting outcomes. This study is mainly investigating different labor analgesia procedures in different stages since the initiation of the practice in 1999, and assessing their influence on the outcomes to display the trajectory of development of labor analgesia in China of which might fit to the the whole process of the study of labor analgesia throughout the world. All these were done by analyzing the data records since from January 1999 to December 2008.

Conditions
Labor Pain
Being tested
CSEA with PCA, CSEA with IBI, EA with PCA, EA with IBI
Keywords
Combined spinal-epidural analgesia, Patient-controlled analgesia, Epidural 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.

  • CSEA with PCAProcedure or surgery

    Records regarding combined spinal-epidural analgesia with patient-controlled pump

  • CSEA with IBIProcedure or surgery

    Records regarding combined spinal-epidural analgesia with intermittent bolus injection

  • EA with PCAProcedure or surgery

    Records regarding epidural analgesia with patient-controlled pump

  • EA with IBIProcedure or surgery

    Records regarding epidural analgesia with intermittent bolus injection

Study groups in NCT00776581
Study groupRoleWhat they receive
1Records regarding combined spinal-epidural analgesia (CSEA) with patient-controlled analgesia (PCA) pump
Receives: Procedure: CSEA with PCA
2Records regarding combined spinal-epidural analgesia with intermittent bolus injection (IBI)
Receives: Procedure: CSEA with IBI
3Records regarding epidural analgesia (EA) with patient-controlled pump
Receives: Procedure: EA with PCA
4Records regarding epidural analgesia with intermittent bolus injection
Receives: Procedure: EA with IBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of cesarean delivery

    Measured: Analgesia initiation to successful vaginal delivery

Secondary outcomes (13)

  1. Rate of instrument-assisted delivery

    Measured: Analgesia initiation to successful vaginal delivery

  2. Indications of cesarean delivery

    Measured: Analgesia initiation to cesarean section

  3. Maternal Visual Analog Scale (VAS) rating of pain

    Measured: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery

  4. Duration of analgesia

    Measured: Initiation of analgesia to the disappearance of sensory block

  5. Maternal satisfaction with analgesia

    Measured: At the end of the vaginal delivery

  6. Maternal oral temperature

    Measured: Analgesia initiation to successful vaginal delivery

  7. Use of oxytocin after analgesia

    Measured: After analgesia to vaginal delivery

  8. Low back pain at 3 months after vaginal delivery

    Measured: At the third month after vaginal delivery

  9. Breastfeeding success at 6 weeks after vaginal delivery

    Measured: At the sixth week after successful delivery

  10. Neonatal one-minute Apgar scale

    Measured: At the first minute of baby was born

  11. Neonatal five-minute Apgar scale

    Measured: At the fifth minute of baby was born

  12. Incidence of maternal side effects

    Measured: Analgesia initiation to successful vaginal delivery

  13. Umbilical-cord gases analysis

    Measured: At the time baby was born

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
40,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00776581
Sponsor's protocol ID
NMU-FY2008-MZ013
Other IDs
NJFY081005
Acronym
POPIC
Status last verified
Sep 2009
First submitted
20 Oct 2008
Last updated
18 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of 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 1 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 18 Sep 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: Analgesia initiation to successful vaginal delivery). 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 NCT00776581.

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 18 Sep 2009.

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