NCT06151483

Brief Summary

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

August 21, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

November 21, 2023

Last Update Submit

August 19, 2024

Conditions

Outcome

Outcome Measures

Primary Outcomes (2)

  • pH

    From umbilical arterial blood gases.

    Immediately after delivery

  • Base excess

    From umbilical arterial blood gases.

    Immediately after delivery

Secondary Outcomes (8)

  • The incidence of post-spinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia.

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension.

    1-15 minutes after spinal anesthesia

  • +3 more secondary outcomes

Study Arms (2)

Standard group

ACTIVE COMPARATOR

The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Drug: Alpha-Agonist

Intensive group

EXPERIMENTAL

The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Other: α-adrenergic receptor agonist

Interventions

Alpha-AgonistDRUG

The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Also known as: Vasopressors
Standard group
α-adrenergic receptor agonistOTHER

The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Also known as: Vasopressors
Intensive group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

  • Body height \< 150 cm
  • Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
  • Hemoglobin \< 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Vasoconstrictor Agents

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Xinli Ni, M.D.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

December 1, 2023

Primary Completion

August 19, 2024

Study Completion

August 19, 2024

Last Updated

August 21, 2024

Record last verified: 2023-12

Locations

CN(1)