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
About this trial
This is an interventional diagnostic trial for Neonatal Hyperbilirubinemia focused on measuring oxytocin
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
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
NCT ID
NCT02602301
First Posted
November 8, 2015
Last Updated
November 10, 2015
Sponsor
Kasr El Aini Hospital
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
Learn more about this trial
The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels
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