NCT03381495

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 16, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

December 2, 2017

Last Update Submit

July 11, 2018

Conditions

Labor PainPregnancy OutcomesPsychological Disorder

Keywords

Epidural Labor Analgesialength of labor stagefetal outcomesmaternal outcomespostpartum depressionexercise

Outcome Measures

Primary Outcomes (1)

  • Labor duration

    Duration of three stages of labor.

    At the end of the delivery

Secondary Outcomes (6)

  • 1 minute Apgar index

    1 minute after the infant is born

  • 5 minute Apgar index

    5 minutes after the infant is born

  • 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.

  • Modified Bromage scores

    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

    3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.

  • +1 more secondary outcomes

Study Arms (2)

Epidural analgesia during labor

EXPERIMENTAL

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

Non-epidural analgesia during labor

NO INTERVENTION

Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor

Interventions

Ropivacaine Hydrochloride, SufentanilDRUG

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.

Epidural analgesia during labor

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy and full term pregnant women

You may not qualify if:

  • the pregnant women with complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33655955DERIVED

MeSH Terms

Conditions

Labor PainMental DisordersDepression, PostpartumMotor Activity

Interventions

RopivacaineSufentanil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersBehavior

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Xun Gong

CONTACT

+8613886174675gongxun4019@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor,chief doctor

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 22, 2017

Study Start

May 16, 2018

Primary Completion

September 1, 2018

Study Completion

December 31, 2019

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

CN(1)