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

Primary Purpose

Neonatal Hyperbilirubinemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Hyperbilirubinemia focused on measuring oxytocin

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    neonatal bilirubin level
    11/2015 to March 2016

    Secondary Outcome Measures

    neonatal APGAR score
    11/2015 to 3 /2015

    Full Information

    First Posted
    November 8, 2015
    Last Updated
    November 10, 2015
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02602301
    Brief Title
    The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels
    Official Title
    The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels .A Prospective Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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)
    Detailed Description
    This prospective randomized case-controlled study was performed at the Obstetrics and Gynecology causality Department of Kasr El Aini University hospital, Cairo University, Egypt in the period from November 2015 to March 2016. The study was approved by the Hospital Ethical Committee. Informed consents were obtained from all patients after explanation of the aim of the study & the potential risks. The study was not supported by any pharmacological company. 327 multigravidas with singleton living healthy fetus presented to the casuality department with spontaneous onset of labour & gave birth through the vaginal route were enrolled in the study. They were randomized into 3 groups: group A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%, group B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% & group C (control group) in which 109 women continued their labour course without any further augmentation. Inclusion criteria included: 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. 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 & epidural analgesia. Neonates with one or more of the following criteria were excluded: Apgar score < 5 or <7 at one minute or five minutes respectively, low birth weight (< 2.5 kg), birth trauma or abnormal G6PD enzyme levels. For all patients, full history was taken followed by complete physical examination & obstetric ultrasound. Initial baseline CTG was done to confirm fetal wellbeing. Patient was then randomized to one of the three groups. 5 units oxytocin was placed in 500 cc of isotonic saline 0.9% or 5% glucose With the beginning of active phase (defined as fully effaced cervix with 3-4 cm dilatation), the investigator gave the patient either 5 units oxytocin placed in 500 cc of isotonic saline 0.9% (group A) or 5% glucose (group B). The rate of infusion in both groups was 2.5 mIU/min of oxytocin intravenous drip with the dose increased by 2.5 mIU/ml every 20min till effective uterine contractions establishment (defined as the presence of 3 forceful uterine contractions over 10 mins span). Amniotomy was done at cervical dilatation ≥ 6 cm if spontaneous rupture of membranes did not occur. Opioid analgesia was given after the amniotomy (meperidine hydrochloride 50 mg IM). Oral fluid intake was not restricted in all patients. Participants were monitored in bed together with fetal wellbeing surveillance using continuous CTG monitoring. A partogram was maintained throughout labour and vaginal examinations were conducted and recorded every 2 hours. Following fetal delivery, cord was clamped within 2 minutes from birth Sodium and initial bilirubin levels were measured in the cord. Umbilical cord blood samples (10 ml) were obtained from the placental site of divided umbilical cord into heparin test tubes and plasma was separated immediately. Sodium, initial haemtocrit & bilirubin levels were measured. All babies were breastfed. Neonatal capillary blood (obtained by heel prick) bilirubin and haemtocrit concentrations were remeasured on day 1 and 2. Sodium measurement was done using flame photometry while bilirubin level was determined using spectrophotometry. Data collected included total volume of fluid & total oxytocin dose administered till delivery, neonatal Apgar score at birth (1 & 5 minutes), birth weight, cord sodium, haemtocrit & bilirubin levels at birth and neonatal plasma haemtocrit & bilirubin levels on day 1 & 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Hyperbilirubinemia
    Keywords
    oxytocin

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    327 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    group A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%,
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    group B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% .
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Group C in which 109 women continued their labour course without any further augmentation.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    syntocinon
    Intervention Description
    different oxytocin diluents and effect on fetal bilirubin&sodium levels.
    Primary Outcome Measure Information:
    Title
    neonatal bilirubin level
    Description
    11/2015 to March 2016
    Time Frame
    5 months.
    Secondary Outcome Measure Information:
    Title
    neonatal APGAR score
    Description
    11/2015 to 3 /2015
    Time Frame
    5 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kasr El Ainy
    Organizational Affiliation
    kasr el ainy street,cairo,egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    mohamed el sharkawy, M.D.
    Organizational Affiliation
    72 A Manial street,4thfloor.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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