NCT05427968

Brief Summary

Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 16, 2022

Last Update Submit

June 16, 2022

Conditions

Keywords

HypotensionCesarean SectionAortocaval CompressionLeft titl

Outcome Measures

Primary Outcomes (2)

  • Group 1 - Supine Group

    Systolic blood pressures decreased significantly in the supine group

    December 2021 to February 2022

  • Group 2 - Left tilt Group

    The decrease in the diastolic blood pressure was marginally significant in the left tilt group.

    December 2021 to February 2022

Study Arms (2)

Supine group

Spinal anaesthesia was administered in sitting position and then supine position was maintained.

Left tilt group

Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females included undergoing C-section
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).

You may qualify if:

  • Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.

You may not qualify if:

  • Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index \> 30 kg.m2), intrauterine growth were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Medical University

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 22, 2022

Study Start

December 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations