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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03381495
Other study ID # TJ-C20171201
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 16, 2018
Est. completion date December 31, 2019

Study information

Verified date July 2018
Source Tongji Hospital
Contact Xun Gong
Phone +8613886174675
Email gongxun4019@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2019
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

healthy and full term pregnant women

Exclusion Criteria:

the pregnant women with complications

Study Design


Intervention

Drug:
Ropivacaine Hydrochloride, Sufentanil
In this research one group will receive epidural analgesia(Ropivacaine Hydrochloride, Sufentanil), data will be collected and analyzed between this group and non-epidural analgesia group.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Deng Dongrui

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 the delivery
Secondary 1 minute Apgar index The index 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 minute after the infant is born
Secondary 5 minute Apgar index The index 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. 5 minutes after the infant is born
Secondary Visual Analogue Scores(VAS) VAS is the most common pain scale for quantification. The score is from 0 to 10. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
Secondary Modified Bromage scores The modified Bromage score is the most frequently used measure of motor block. The scores is from 0 to 3. 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). That will indicate if the analgesia block the patient motor too much. 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
Secondary Postpartum depression Assess the risk of postpartum depression among all participants using EPDS,HAMA. 3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.
Secondary The mode of delivery Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery. At the end of delivery
See also
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