NCT02602301

Brief Summary

Objective: To evaluate the relationship between intravenous (IV) infusion of oxytocin using either saline 0.9% or glucose 5% \& neonatal Bilirubin \& sodium level. Study Design: A randomized case - controlled study. Setting: The Obstetrics and Gynecology casuality department of Kasr El Aini hospital (Cairo University - Egypt)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
327

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 8, 2015

Last Update Submit

November 10, 2015

Conditions

Neonatal Hyperbilirubinemia

Keywords

oxytocin

Outcome Measures

Primary Outcomes (1)

  • neonatal bilirubin level

    11/2015 to March 2016

    5 months.

Secondary Outcomes (1)

  • neonatal APGAR score

    5 months

Study Arms (3)

1

ACTIVE COMPARATOR

group A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%,

Drug: Oxytocin

2

ACTIVE COMPARATOR

group B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% .

Drug: Oxytocin

3

PLACEBO COMPARATOR

Group C in which 109 women continued their labour course without any further augmentation.

Drug: Oxytocin

Interventions

OxytocinDRUG

different oxytocin diluents and effect on fetal bilirubin\&sodium levels.

Also known as: syntocinon
123

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • maternal age between 20 \& 35 years old, gestational age 37 to 40 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), vertex presentation of the fetus \& intact membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kasr El Ainy

    kasr el ainy street,cairo,egypt

    STUDY DIRECTOR

  • mohamed el sharkawy, M.D.

    72 A Manial street,4thfloor.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
kasr el ainy hospital,kasr el ainy street ,cairo egypt

Study Record Dates

First Submitted

November 8, 2015

First Posted

November 11, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 11, 2015

Record last verified: 2015-11