The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Labor Pain Clinical Trial

Official title:

The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03381495
• Other study ID #: TJ-C20171201
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Labor Pain
• Mental Disorders
• Pregnancy Outcomes
• Psychological Disorder

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