Labor Analgesia in the Latent Phrase

Labor Pain Clinical Trial

— LALP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647725
• Other study ID #: NMU-69714-14XS
• Secondary ID: MCH03552
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: September 30, 2009
• Start date: January 2003
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• Active phrase epidural analgesia
Continuous epidural analgesia with sufentanil plus ropivacaine
• Latent phrase epidural analgesia
Continuous epidural analgesia with sufentanil plus ropivacaine

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang F, Shen X, Guo X, Peng Y, Gu X; Labor Analgesia Examining Group. Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology. 2009 Oct;111(4):871-80. doi: 10.1097/ALN.0b01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cesarean delivery		The time of the end of the labor	Yes
Secondary	Time of latent phrase		From the beginning of regular contraction of uterus to the diameter of cervix to 4cm	Yes
Secondary	Time of labor		From the beginning of regular contraction of uterus to the end of the labor	Yes
Secondary	Overall feeling of satisfaction of analgesia		From the beginning of regular contraction of uterus to the end of the labor	No
Secondary	Side effects		From the beginning of regular contraction of uterus to the end of the labor	Yes
Secondary	VAS pain intensity		From the intinition of analgesia to the cervical dilation >4cm	Yes
Secondary	Instrumental delivery		The end of the time of the labor	Yes
Secondary	Oxytocin infusion rate		During the whole period of laboring	Yes
Secondary	Neonatal Apgar scores		1st min, 5th min, 10th min and 20th min	Yes
Secondary	Umbilical gas measurement		After delivering of the fetus	Yes
Secondary	Maternal oral temperature		From the initiation of analgesia to the end of the labor	Yes
Secondary	Maternal corticosteroids		1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor	Yes