The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Labor Pain; Psychological Disorder; Pregnancy Outcomes
• Intervention / Treatment: Drug: Ropivacaine Hydrochloride, Sufentanil

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Principal Investigator: Haiyi Liu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

healthy and full term pregnant women

Exclusion Criteria:

the pregnant women with complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Epidural analgesia during labor; 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; 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.
NO_INTERVENTION: Non-epidural analgesia during labor; 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

Collaborators and Investigators

• Sponsor: Deng Dongrui

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2018
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 17, 2017
• First Posted (ACTUAL): December 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: exercise; postpartum depression; maternal outcomes; Epidural Labor Analgesia; length of labor stage; fetal outcomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Sufentanil
• Other Study ID Numbers: TJ-C20171201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No