NCT02893696

Brief Summary

After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

September 2, 2016

Last Update Submit

January 29, 2019

Conditions

Complications; Cesarean SectionHypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of fetal umbilical artery pH below 7.20

    At fetal delivery

Secondary Outcomes (1)

  • Incidence of maternal hypotension

    During cesarean surgery

Study Arms (2)

Immediately Supine Position

ACTIVE COMPARATOR

Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug.

Other: Various sitting time

Delayed Supine Position

ACTIVE COMPARATOR

Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug.

Other: Various sitting time

Interventions

Various sitting timeOTHER

Various sitting time

Delayed Supine PositionImmediately Supine Position

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women with elective cesarean delivery at 39-42 wks gestation.

You may not qualify if:

  • Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
  • Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
  • If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Weike Tao, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)