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The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels

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ClinicalTrials.gov Identifier: NCT02602301
Recruitment Status : Unknown
Verified November 2015 by Mohamed El-Sharkawy, Kasr El Aini Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed El-Sharkawy, Kasr El Aini Hospital

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)


Condition or disease Intervention/treatment Phase
Neonatal Hyperbilirubinemia Drug: Oxytocin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels .A Prospective Randomized Controlled Trial.
Study Start Date : November 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice
Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: 1
group A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%,
Drug: Oxytocin
different oxytocin diluents and effect on fetal bilirubin&sodium levels.
Other Name: syntocinon

Active Comparator: 2
group B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% .
Drug: Oxytocin
different oxytocin diluents and effect on fetal bilirubin&sodium levels.
Other Name: syntocinon

Placebo Comparator: 3
Group C in which 109 women continued their labour course without any further augmentation.
Drug: Oxytocin
different oxytocin diluents and effect on fetal bilirubin&sodium levels.
Other Name: syntocinon




Primary Outcome Measures :
  1. neonatal bilirubin level [ Time Frame: 5 months. ]
    11/2015 to March 2016


Secondary Outcome Measures :
  1. neonatal APGAR score [ Time Frame: 5 months ]
    11/2015 to 3 /2015



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women who had chronic or pregnancy induced diseases or any contraindication to vaginal delivery (e.g. malpresentation, contracted pelvis & placenta previa) were excluded. Additional exclusion criteria included rhesus (Rh) negative or (O) blood group mothers, prolonged labour (> 12h), fetal distress, instrumental delivery (forceps or vacuum extraction), abnormal fetal growth (IUGR or macrosomia), non-reassuring initial fetal CTG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602301


Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: Kasr El Ainy kasr el ainy street,cairo,egypt
Principal Investigator: mohamed el sharkawy, M.D. 72 A Manial street,4thfloor.

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Responsible Party: Mohamed El-Sharkawy, kasr el ainy hospital,kasr el ainy street ,cairo egypt, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02602301     History of Changes
Other Study ID Numbers: oxytocin
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Mohamed El-Sharkawy, Kasr El Aini Hospital:
oxytocin

Additional relevant MeSH terms:
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Bilirubin
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents