NCT00647725CompletedNot Applicable
Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery
Nanjing Medical University1 site in 1 country15,000 target enrollmentStarted: January 1, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15,000
- Locations
- 1
- Primary Endpoint
- Rate of Cesarean delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Nulliparas
- •Required labor analgesia
Exclusion Criteria
- •Allergic to opioids and/or local anesthetics
- •Failed to performing epidural catheterization
- •Organic dysfunction
- •Contraindications for epidural analgesia.
Outcomes
Primary Outcomes
Rate of Cesarean delivery
Time Frame: The time of the end of the labor
Secondary Outcomes
- Time of latent phrase(From the beginning of regular contraction of uterus to the diameter of cervix to 4cm)
- Time of labor(From the beginning of regular contraction of uterus to the end of the labor)
- Overall feeling of satisfaction of analgesia(From the beginning of regular contraction of uterus to the end of the labor)
- Side effects(From the beginning of regular contraction of uterus to the end of the labor)
- VAS pain intensity(From the intinition of analgesia to the cervical dilation >4cm)
- Instrumental delivery(The end of the time of the labor)
- Oxytocin infusion rate(During the whole period of laboring)
- Neonatal Apgar scores(1st min, 5th min, 10th min and 20th min)
- Umbilical gas measurement(After delivering of the fetus)
- Maternal oral temperature(From the initiation of analgesia to the end of the labor)
- Maternal corticosteroids(1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor)
Investigators
Study Sites (1)
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