Labor Analgesia in the Latent Phrase (LALP)

September 30, 2009 updated by: Nanjing Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparas
  • Required labor analgesia
  • Chinese.

Exclusion Criteria:

  • Allergic to opioids and/or local anesthetics
  • Failed to performing epidural catheterization
  • Organic dysfunction
  • Contraindications for epidural analgesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
Active phrase analgesia
Procedure: Active phrase epidural analgesia
Continuous epidural analgesia with sufentanil plus ropivacaine
Active Comparator: II
Latent phrase analgesia
Procedure: Latent phrase epidural analgesia
Continuous epidural analgesia with sufentanil plus ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Cesarean delivery
Time Frame: The time of the end of the labor
The time of the end of the labor

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall feeling of satisfaction of analgesia
Time Frame: From the beginning of regular contraction of uterus to the end of the labor
From the beginning of regular contraction of uterus to the end of the labor
Time of latent phrase
Time Frame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm
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
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
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
From the intinition of analgesia to the cervical dilation >4cm
Instrumental delivery
Time Frame: The end of the time of the labor
The end of the time of the labor
Oxytocin infusion rate
Time Frame: During the whole period of laboring
During the whole period of laboring
Neonatal Apgar scores
Time Frame: 1st min, 5th min, 10th min and 20th min
1st min, 5th min, 10th min and 20th min
Umbilical gas measurement
Time Frame: After delivering of the fetus
After delivering of the fetus
Maternal oral temperature
Time Frame: From the initiation of analgesia to the end of the labor
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
1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2009

Last Update Submitted That Met QC Criteria

September 30, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-69714-14XS
  • MCH03552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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