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CompletedNCT06099938Updated Oct 25, 2023

Effect of Different Labour Analgesics on Maternal and Fetal Blood Flow Observed by Doppler Ultrasonography

An observational study in Labor Pain, Analgesia and Fetus Disorder, sponsored by First Affiliated Hospital of Jinan University. Completed at 1 site in China. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by First Affiliated Hospital of Jinan University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
20 Years to 35 Years
Sex
Female
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Study 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。

Read the detailed description
  1. Randomization and blinding Parturients in the study were randomly assigned to Sufentanil group (S) and Ropivacaine group (R) by non-blind personnel according to the computer random number table, and the allocation was hidden. The solution was prepared by an unblinded anesthesiologist and packaged in a blind way and administered by another anesthesiologist. The patients, anesthesia providers, data recorders, ultrasound examiners, obstetrical staff, and nursing staff remained blinded to group assignment throughout the study.
  2. Study intervention At the time of request for labor analgesia, patients were randomized to receive either sufentanil 5 μg (Group S) and ropivacaine 3mg (Group R) into the subarachnoid space. All groups received the standard epidural solution that contained 0.1% ropivacaine with 0.25 μg/ml sufentanil. Routine obstetric and anaesthetic monitoring was given after maternal entered the delivery room. An experienced the anesthesiologist select L3-4 lumbar vertebra clearance to puncture with standard sterile technique using loss of resistance when the puerpera palace has expanded to about 3 cm. After the puncture reached the epidural space, a 25-gauge lumbar anesthesia needle was used to puncture into the subarachnoid space. 2 mL of anesthetic drug as determined by her group randomization were administered into the cavity through the lumbar anesthesia needle after cerebrospinal fluid flow out. A 19-gauge spring-wound catheter was threaded 4-6 cm into the epidural space. All patients received a test dose of 3 ml of 1.5% lidocaine followed by an initial loading dose of 5 ml of the standard epidural solution. Epidural catheters into vessels or subarachnoid space were excluded. An analgesic pump (PCEA pump, 100ml) containing standard epidural solution was then connected to the epidural catheter at a background continuous infusion rate of 5 mL/h. The visual analogue score for pain (VAS) was performed 15 minutes after the injection dose, and if the VAS score fell below 3, the case was included in the study.

    An anesthesia provider assessed the adequacy of analgesia for the patients throughout the duration of labor. Any breakthrough pain was managed with a physician-administered epidural bolus. All obstetric analgesia procedures were performed by the same anesthesiologist to reduce errors due to technical reasons.

  3. Ultrasonic examination method The patients were placed in a supine position with calm breathing to perform doppler ultrasonography during the interval of contractions. Ultrasound probe was placed on fetal head area. Middle cerebral arteries (MCA) run anteriorly on both sides of the ring of cerebral arteries at the position of the double head diameter (see Figure 1A). We can get waveforms of MCA examined by pulsed wave doppler (see Figure 1B). The probe was placed at the placenta area, and we can see the fetal umbilical cord connecting to the center of the placenta. Umbilical artery (UA) could be identified by color flow, and its waveforms were examined by pulsed wave doppler (see Figure 1C and 1D). The probe was placed at the midpoint of the groin. The right and left uterine arteries (UtA) could be identified by color flow at the apparent crossover with the external iliac arteries, and pulsed wave doppler was used to obtain waveforms (see Figure 1E and 1F). 3 to 10 arterial spectrograms with clear edges and no background noise at baseline were selected. The above arterial blood flow indexes were measured three times and the average value was taken. The S/Dvalue of MCA、UA、UtA can be measured automatically by ultrasound instrument. All doppler examinations were performed by the same sonographer.
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Conditions studied

  • Labor Pain
  • Analgesia
  • Fetus Disorder

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Keywords

  • Sufentanil
  • Ropivacaine
  • Labor analgesia
  • Color Doppler ultrasound
  • Middle cerebral artery
  • Uterine artery
  • Umbilical artery
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In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 90 is below the median of 101 across 56 observational studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

First Affiliated Hospital of Jinan University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability 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

Inclusion criteria

  1. ASA grade I to II
  2. Aged 20 to 35 years
  3. Weighing 50 to 100 kg
  4. 150-175 cm in height
  5. 37 to 41 weeks of gestation

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Group S

    intrathecal injections of sufentanil

    Drug: sufentanil, ropivacaine

  • Group R

    intrathecal injections of ropivacaine

    Drug: sufentanil, ropivacaine

Interventions

  • Drugsufentanil, ropivacaine

    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

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What researchers measure

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.

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

Secondary outcomes

  1. FHR

    Fetal heart rate

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

  2. MAP

    Mean arterial pressure

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

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Study locations

1 site
  • First Affiliated Hospital of Jinan University
    Guangzhou, Guangdong 510000, China
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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2021

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06099938
Lead sponsor
First Affiliated Hospital of Jinan University
Responsible party
Yuqiong Liu (principal investigator, First Affiliated Hospital of Jinan University) — Principal investigator
First posted
Oct 25, 2023
Start date
Mar 1, 2021
Primary completion
Dec 1, 2021
Completion
Jan 1, 2022
Last update
Oct 25, 2023

Study contacts

Xuemei Peng, Ph.d
principal investigator · First Affiliated Hospital of Jinan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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