Labor Long, Labor Pain, Labor Fetal Anoxia
Conditions
Keywords
Combined spinal-epidural analgesia, Epidural analgesia, Labor duration
Brief summary
The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.
Detailed description
Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.
Interventions
PROCEDURECombined spinal-epidural analgesia
Combined spinal-epidural analgesia during labor is a labor analgesia technique which reported maybe associate with a shorter labor duration compared to the traditional epidural labor analgesia.
PROCEDUREEpidural analgesia
Epidural analgesia is a well-accepted technique using for pain relief during labor.
Sponsors
Tongji Hospital
Deng Dongrui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
One anesthetist who were not involved with clinical care or data collection performed the randomization procedure and the neuraxial block according to the group allocation. The other anesthetist blinds to the procedure preform the analgesia management after neuraxial block. This anesthetist and the obstetrician, the midwives, the patients , the outcomes collector and assessor are all blind to group allocation throughout.
Intervention model description
Participants who request neuraxial labor analgesia are randomly assigned into two groups by a computer-generated random number table using Excel. One group received combined spinal-epidural analgesia during labor, the other group received epidural analgesia during labor.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.
Exclusion criteria
* Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labor duration | At the end of delivery | Duration of three stages of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mode of delivery | At the end of delivery | Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery |
| 1 minute and 5 minutes Apgar scores | 1 min after delivery, 5 min after delivery. | Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10. |
| Visual Analogue Scores(VAS) | At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta. | VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants. |
| Modified Bromage scores | At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at the cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta. | The modified Bromage score is the most frequently used measure of motor block. In this scale, the intensity of motor block is assessed by the patient's ability to move their lower extremities(0: no motor paralysis; 1: inability to raise extended leg, but able to move knee and foot; 2: inability to raise extended leg and to move knee, but able to move foot; 3: inability to raise extended leg or to move knee and foot). |
Countries
China
Contacts
Primary ContactDongji Han, M.D.
Backup ContactXun Gong, M.D.
Outcome results
None listed