Labor Analgesia in the Latent Phrase - Full Text View

Sponsor:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00647725

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
I: Active Comparator Active phrase analgesia	Procedure: Active phrase epidural analgesia Continuous epidural analgesia with sufentanil plus ropivacaine
II: Active Comparator 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

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:

Wang F, Shen X, Guo X, Peng Y, Gu X; The Labor Analgesia Examining Group (LAEG). Epidural Analgesia in the Latent Phase of Labor and the Risk of Cesarean Delivery: A Five-year Randomized Controlled Trial. Anesthesiology. 2009 Sep 7; [Epub ahead of print]

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

Keywords provided by Nanjing Medical University:

Epidural analgesia
Latent analgesia
Active analgesia
Labor delivery

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Labor Pain
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on November 30, 2009