NCT04991662

Brief Summary

This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

December 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

June 9, 2021

Last Update Submit

December 9, 2021

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Umbilical artery blood pH

    pH value of fetal umbilical artery blood

    30 seconds after delivery

Secondary Outcomes (5)

  • hypotension

    Intraoperative

  • bradycardia

    Intraoperative

  • The incidence of nausea in pregnant women

    Intraoperative

  • Umbilical artery blood base excess

    30sec after delivery

  • The incidence of vomiting in pregnant women

    Intraoperative

Study Arms (3)

metaraminol group

EXPERIMENTAL

During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension.

Drug: metaraminol

phenylephrine group

EXPERIMENTAL

During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension.

Drug: Phenylephrine

norepinephrine group

EXPERIMENTAL

During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension.

Drug: Norepinephrine

Interventions

metaraminolDRUG

Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Also known as: M group
metaraminol group
PhenylephrineDRUG

Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Also known as: P group
phenylephrine group
NorepinephrineDRUG

Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Also known as: N group
norepinephrine group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
  • height 150-180 cm;
  • American Society of Anesthesiologists (ASA) physical status II-III;
  • body mass index (BMI) \<35 kg/m2.

You may not qualify if:

  • transverse presentation, fetal macrosomia;
  • uterine abnormalities (eg, large fibroids, bicornuate uterus);
  • polyhydramnios;
  • ruptured membranes, oligohydramnios;
  • intrauterine growth restriction;
  • gestational or nongestational hypertension, diabetes, or eclampsia;
  • hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
  • contraindications for combined spinal-epidural anesthesia;
  • participants who declined to sign informed consent forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

MetaraminolPhenylephrineNorepinephrine

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesEthanolaminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Feng Yi, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology

Study Record Dates

First Submitted

June 9, 2021

First Posted

August 5, 2021

Study Start

October 10, 2021

Primary Completion

December 3, 2021

Study Completion

December 3, 2021

Last Updated

December 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)