Labor Analgesia in the Latent Phrase - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2008

Last Updated Date

September 30, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647725 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Labor Analgesia in the Latent Phrase

Official Title ^ICMJE

Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery

Brief 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. 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Labor Pain

Intervention ^ICMJE

Procedure: Active phrase epidural analgesia
Procedure: Latent phrase epidural analgesia

Study Arms / Comparison Groups

Active Comparator: Active phrase analgesia
Active Comparator: Latent phrase analgesia

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]

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

15000

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00647725

Responsible Party

XiaoFeng Shen, Nanjing Medical University

Study ID Numbers ^ICMJE

NMU-69714-14XS, MCH03552

Study Sponsor ^ICMJE

Nanjing Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

Information Provided By

Nanjing Medical University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP