Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being

NCT ID: NCT02893696

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Complications; Cesarean Section Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediately Supine Position

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

Group Type ACTIVE_COMPARATOR

Various sitting time

Intervention Type OTHER

Various sitting time

Delayed Supine Position

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

Group Type ACTIVE_COMPARATOR

Various sitting time

Intervention Type OTHER

Various sitting time

Interventions

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Various sitting time

Various sitting time

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weike Tao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU012016-059

Identifier Type: -

Identifier Source: org_study_id

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