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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03600272
Other study ID # TJ-C20180711
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 20, 2018
Est. completion date July 20, 2019

Study information

Verified date July 2018
Source Tongji Hospital
Contact Dongji Han, M.D.
Phone +8618971583899
Email handongjihospital@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 20, 2019
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Combined 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.
Epidural analgesia
Epidural analgesia is a well-accepted technique using for pain relief during labor.

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Deng Dongrui Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Labor duration Duration of three stages of labor At the end of delivery
Secondary The mode of delivery Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery At the end of delivery
Secondary 1 minute and 5 minutes Apgar scores 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. 1 min after delivery, 5 min after delivery.
Secondary Visual Analogue Scores(VAS) 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. 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.
Secondary Modified Bromage scores 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). 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.
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