Back to resultsThe Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Primary Purpose
Labor Pain, Pregnancy Outcomes, Psychological Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine Hydrochloride, Sufentanil
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Epidural Labor Analgesia, length of labor stage, fetal outcomes, maternal outcomes, postpartum depression, exercise
Eligibility Criteria
Inclusion Criteria:
healthy and full term pregnant women
Exclusion Criteria:
the pregnant women with complications
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Epidural analgesia during labor
Non-epidural analgesia during labor
Arm Description
The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.
Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor
Outcomes
Primary Outcome Measures
Labor duration
Duration of three stages of labor.
Secondary Outcome Measures
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.
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.
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.
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.
Postpartum depression
Assess the risk of postpartum depression among all participants using EPDS，HAMA.
The mode of delivery
Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03381495
Brief Title
The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Official Title
The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deng Dongrui
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Pregnancy Outcomes, Psychological Disorder
Keywords
Epidural Labor Analgesia, length of labor stage, fetal outcomes, maternal outcomes, postpartum depression, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural analgesia during labor
Arm Type
Experimental
Arm Description
The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.
Arm Title
Non-epidural analgesia during labor
Arm Type
No Intervention
Arm Description
Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride, Sufentanil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Labor duration
Description
Duration of three stages of labor.
Time Frame
At the end of the delivery
Secondary Outcome Measure Information:
Title
1 minute Apgar index
Description
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.
Time Frame
1 minute after the infant is born
Title
5 minute Apgar index
Description
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.
Time Frame
5 minutes after the infant is born
Title
Visual Analogue Scores(VAS)
Description
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.
Time Frame
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.
Title
Modified Bromage scores
Description
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.
Time Frame
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.
Title
Postpartum depression
Description
Assess the risk of postpartum depression among all participants using EPDS，HAMA.
Time Frame
3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.
Title
The mode of delivery
Description
Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.
Time Frame
At the end of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy and full term pregnant women
Exclusion Criteria:
the pregnant women with complications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Gong
Phone
+8613886174675
Email
gongxun4019@163.com
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Gong, M.D.
Phone
+8613886174675
Email
gongxun4019@163.com
First Name & Middle Initial & Last Name & Degree
Dongji Han, M.D.
Phone
+8618971583899
Email
handongjihospital@163.com
First Name & Middle Initial & Last Name & Degree
Haiyi Liu, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
33655955
Citation
Zha Y, Gong X, Yang C, Deng D, Feng L, Luo A, Wan L, Qiao F, Zeng W, Chen S, Wu Y, Han D, Liu H. Epidural analgesia during labor and its optimal initiation time-points: A real-world study on 400 Chinese nulliparas. Medicine (Baltimore). 2021 Mar 5;100(9):e24923. doi: 10.1097/MD.0000000000024923.
Results Reference
derived
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The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
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