Clinical trial NCT00647725: Labor Analgesia in the Latent Phrase
Official title: Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Epidural analgesia
Latent analgesia
Active analgesia
Labor delivery
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Rate of Cesarean delivery
timeFrame: The time of the end of the labor
Secondary outcomes:
measure: Time of latent phrase
timeFrame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm
measure: Time of labor
timeFrame: From the beginning of regular contraction of uterus to the end of the labor
measure: Overall feeling of satisfaction of analgesia
timeFrame: From the beginning of regular contraction of uterus to the end of the labor
measure: Side effects
timeFrame: From the beginning of regular contraction of uterus to the end of the labor
measure: VAS pain intensity
timeFrame: From the intinition of analgesia to the cervical dilation >4cm
measure: Instrumental delivery
timeFrame: The end of the time of the labor
measure: Oxytocin infusion rate
timeFrame: During the whole period of laboring
measure: Neonatal Apgar scores
timeFrame: 1st min, 5th min, 10th min and 20th min
measure: Umbilical gas measurement
timeFrame: After delivering of the fetus
measure: Maternal oral temperature
timeFrame: From the initiation of analgesia to the end of the labor
measure: Maternal corticosteroids
timeFrame: 1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
citation: 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.0b013e3181b55e65.