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The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03381495
Enrollment
200
Registered
2017-12-22
Start date
2018-05-16
Completion date
2019-12-31
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain, Pregnancy Outcomes, Psychological Disorder

Keywords

Epidural Labor Analgesia, length of labor stage, fetal outcomes, maternal outcomes, postpartum depression, exercise

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.

Interventions

DRUGRopivacaine 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.

Sponsors

Deng Dongrui
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

healthy and full term pregnant women

Exclusion criteria

the pregnant women with complications

Design outcomes

Primary

MeasureTime frameDescription
Labor durationAt the end of the deliveryDuration of three stages of labor.

Secondary

MeasureTime frameDescription
5 minute Apgar index5 minutes after the infant is bornThe 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)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.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.
1 minute Apgar index1 minute after the infant is bornThe 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.
Postpartum depression3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.Assess the risk of postpartum depression among all participants using EPDS,HAMA.
The mode of deliveryAt the end of deliveryIncluding spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.
Modified Bromage scores5min 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.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.

Countries

China

Contacts

Primary ContactXun Gong
gongxun4019@163.com+8613886174675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026