NCT05874687

Brief Summary

This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study. Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.

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
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 11, 2023

Last Update Submit

May 23, 2023

Conditions

Hypotension

Keywords

Tricuspid Annuler Plane Systolic ExcursionHypotension-Ceserean sectionSpinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • ceserenan tapse

    The primary outcome measure was the development of hypotension after spinal anesthesia.

    3 months

Study Arms (2)

1: hypotension +,

hypotension +: hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg

Drug: hypotension + treat

2:hypotension -

hypotension -:none hypotension (hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg)

Interventions

hypotension + treatDRUG

Heart Rate and Mean Arterial Pressure (MAP) will be recorded throughout the procedure (every 2 minutes for the first 15 minutes). Ephedrine (in 6 mg increments) will be used as well as the isotonic balanced crystalloid solution to treat hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg (250 mL bolus). The Ephedrine dose will be recorded. Bradycardia, which is defined as a heart rate less than 50 beats per minute, will be treated with intravenous Atropine (0.5 mg).

1: hypotension +,

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue to the cesarean section, only female patients will be included in the study.
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study

You may qualify if:

  • ASA 2
  • gestational-week single pregnancies
  • Being between the ages of 20-35
  • BMI between 20-35

You may not qualify if:

  • Non-sinus rhythm
  • ASA III and above
  • Known heart disease
  • Multiple pregnancy
  • Expected massive intraoperative loss (i.e., placenta accreta or placenta previa)
  • Severe pulmonary hypertension, wall motion disorder, severe valve disease, hypertrophic or dilated cardiomyopathy in echocardiography
  • A TAPSE value of 1.7 cm or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Maternity and Child Health Hospital

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TarsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDİCİNE DOCTOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

TU(1)