Analgesia, Obstetrical, Early Medical Intervention, Labor Pain
Conditions
Keywords
severity of labor pain, individualized administration, neuraxial labor analgesia
Brief summary
Neuraxial analgesia is the gold standard to relieve labor pain. A recent Practice guidelines for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or on a individualized basis. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.
Detailed description
Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate maternal anxiety and improve maternal satisfaction. A recent Practice guidelines for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or, for some special patients, be provided on a individualized basis. Studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.
Interventions
DRUGIndividualized epidural analgesia
Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the numeric rating scale is 5 or higher. Analgesia will be terminated at the end of the third stage of labor.
DRUGRoutine epidural analgesia
Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the cervix is dilated to 1 cm or more. Analgesia will be terminated at the end of the third stage of labor.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
1. Nulliparas (aged 18-36 years) with single cephalic term pregnancy; 2. Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians; 3. Admitted to the delivery room; 4. Agree to receive epidural analgesia during labor.
Exclusion criteria
1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy. 3. Other reasons that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The most severe labor pain score during labor | Assessed at 24 hours after delivery | Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cesarean delivery | At the time of delivery | Incidence of Cesarean delivery |
| Neonatal Apgar score | At 1 and 5 minutes after delivery | Neonatal Apgar score |
| Maternal satisfaction with labor analgesia | Assessed at 24 hours after delivery | Assessed with the Likert scale, where 1=extremely dissatisfaction, 2=dissatisfaction, 3=neither dissatisfaction nor satisfaction, 4=satisfaction, 5=extremely satisfaction. |
| Incidence of instrumental delivery | At the time of delivery | Incidence of instrumental delivery |
| Rate of breast-feeding | At 24 hours and 42 days after delivery | Rate of breast-feeding |
| Incidence of postpartum depression | At 42 days after delivery | Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher. |
| Persistent pain score at 24 hours and 42 days after delivery | At 24 hours and 42 days after delivery | Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain. |
Countries
China
Outcome results
None listed