Supine Versus Left Lateral Tilted Position During Cesarean Delivery

NCT ID: NCT03182114

Last Updated: 2018-07-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2019-01-20

Brief Summary

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In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position

Detailed Description

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Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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supine position

the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position

Group Type PLACEBO_COMPARATOR

supine position

Intervention Type OTHER

the patient will be placed in regular supine position after spinal anesthesia

Bupivacaine

Intervention Type DRUG

The patient will receive 10 mg Bupivacaine for spinal anesthesia

Left lateral tilted position

the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position

Group Type EXPERIMENTAL

left lateral tilted position

Intervention Type OTHER

the patient will be placed in left lateral tilted position after spinal anesthesia

Bupivacaine

Intervention Type DRUG

The patient will receive 10 mg Bupivacaine for spinal anesthesia

Interventions

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supine position

the patient will be placed in regular supine position after spinal anesthesia

Intervention Type OTHER

left lateral tilted position

the patient will be placed in left lateral tilted position after spinal anesthesia

Intervention Type OTHER

Bupivacaine

The patient will receive 10 mg Bupivacaine for spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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Inclusion Criteria

* full term
* singleton pregnant women
* scheduled for elective cesarean delivery

Exclusion Criteria

* Cardiac morbidities
* hypertensive disorders of pregnancy
* peripartum bleeding
* baseline systolic blood pressure (SBP) \< 100 mmHg
* body mass index \> 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mukhtar, Professor

Role: STUDY_CHAIR

Head of research committee section in anesthesia department

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Shash, Professor

Role: CONTACT

+201001033999

Facility Contacts

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ahmed Hasanin, Lecturer

Role: primary

+2010095076954

Other Identifiers

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N-52-2017

Identifier Type: -

Identifier Source: org_study_id

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