The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Study Overview
=================
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.

Official Title
-----------------
The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Conditions
-----------------
Labor Pain, Pregnancy Outcomes, Psychological Disorder

Intervention / Treatment
-----------------
* Drug: Ropivacaine Hydrochloride, Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy and full term pregnant women Exclusion Criteria: the pregnant women with complications

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural analgesia during labor<br>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. | Drug: Ropivacaine Hydrochloride, Sufentanil<br>* 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.<br>|
| No Intervention: Non-epidural analgesia during labor<br>Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labor duration | Duration of three stages of labor. | At the end of the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| The mode of delivery | Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery. | At the end of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, Epidural Labor Analgesia, length of labor stage, fetal outcomes, maternal outcomes, postpartum depression