NCT06099938

Brief Summary

Background: The purpose of this study was to see how intrathecal injections of sufentanil, ropivacaine, and sufentanil added to ropivacaine affected blood flow in the uterine artery, umbilical artery, and middle cerebral artery for combined spinal and epidural labor analgesia using color doppler ultrasound (CDUs). Methods: A total of 90 singleton full-term parturients who were evaluated by obstetricians for feasible vaginal delivery were collected prospectively and divided into three groups based on the randomization and double-blind principle: sufentanil (S), ropivacaine (R) group, each with 30 cases. Main indicators include color doppler blood flow resistance indices (S/D) of the uterine artery (UtA), umbilical artery (UA), and middle cerebral artery (MCA) before (T0) and 30 minutes (T1), 60 minutes (T2), 90minutes (T3) after analgesia. Fetal heart rate (FHR), maternal mean arterial pressure (MAP) at T0, T1, T2 and T3。

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

June 14, 2023

Last Update Submit

October 19, 2023

Conditions

Labor PainAnalgesiaFetus Disorder

Keywords

SufentanilRopivacaineLabor analgesiaColor Doppler ultrasoundMiddle cerebral arteryUterine arteryUmbilical artery

Outcome Measures

Primary Outcomes (1)

  • color doppler blood flow resistance indices (S/D）

    S/D is an abbreviation for systolic/diastolic blood pressure.The patients were placed in a supine position with calm breathing to perform Doppler ultrasonography during the interval of contractions.

    S/D measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia

Secondary Outcomes (2)

  • FHR

    Fetal heart rate measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia

  • MAP

    Mean arterial pressure before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia

Study Arms (2)

Group S

intrathecal injections of sufentanil

Drug: sufentanil, ropivacaine

Group R

intrathecal injections of ropivacaine

Drug: sufentanil, ropivacaine

Interventions

sufentanil, ropivacaineDRUG

The study used conventional anesthetic drugs to compare the effects of the two drugs on maternal and infant blood flow

Also known as: Color Doppler ultrasound
Group RGroup S

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

ASA grade I to II, aged 20 to 35 years, weighing 50 to 100 kg, 150-175 cm in height, and 37 to 41 weeks of gestation

You may qualify if:

  • ASA grade I to II
  • Aged 20 to 35 years
  • Weighing 50 to 100 kg
  • cm in height
  • to 41 weeks of gestation

You may not qualify if:

  • Women with contraindications of spinal anesthesia
  • Maternal complications (such as pregnancy-induced hypertension, preeclampsia, cardiovascular and cerebrovascular diseases, etc.)
  • Abnormal uterine contractions
  • Abnormal placental function or position
  • Signs of fetal distress
  • Known fetal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Labor PainAgnosiaFetal Diseases

Interventions

SufentanilRopivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Xuemei Peng, Ph.d

    First Affiliated Hospital of Jinan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 14, 2023

First Posted

October 25, 2023

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

CN(1)