Labor Analgesia in the Latent Phrase (LALP)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00647725
First received: March 28, 2008
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Labor Pain
Procedure: Active phrase epidural analgesia
Procedure: Latent phrase epidural analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of Cesarean delivery [ Time Frame: The time of the end of the labor ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time of latent phrase [ Time Frame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm ] [ Designated as safety issue: Yes ]
  • Time of labor [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ]
  • Overall feeling of satisfaction of analgesia [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ]
  • VAS pain intensity [ Time Frame: From the intinition of analgesia to the cervical dilation >4cm ] [ Designated as safety issue: Yes ]
  • Instrumental delivery [ Time Frame: The end of the time of the labor ] [ Designated as safety issue: Yes ]
  • Oxytocin infusion rate [ Time Frame: During the whole period of laboring ] [ Designated as safety issue: Yes ]
  • Neonatal Apgar scores [ Time Frame: 1st min, 5th min, 10th min and 20th min ] [ Designated as safety issue: Yes ]
  • Umbilical gas measurement [ Time Frame: After delivering of the fetus ] [ Designated as safety issue: Yes ]
  • Maternal oral temperature [ Time Frame: From the initiation of analgesia to the end of the labor ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15000
Study Start Date: January 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647725

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Publications:
Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00647725     History of Changes
Other Study ID Numbers: NMU-69714-14XS, MCH03552
Study First Received: March 28, 2008
Last Updated: September 30, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Epidural analgesia
Latent analgesia
Active analgesia
Labor delivery

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014