Neonatal HyperbilirubinemiaPhase 4NCT02602301
The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels
A Phase 4 study testing Oxytocin in people with Neonatal Hyperbilirubinemia, run by Kasr El Aini Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels .A Prospective Randomized Controlled Trial.
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)
Read the 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.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Oxytocin
- Keywords
- oxytocin
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
different oxytocin diluents and effect on fetal bilirubin\&sodium levels.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | group A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%, Receives: Drug: Oxytocin |
| 2 | Active comparator | group B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% . Receives: Drug: Oxytocin |
| 3 | Placebo comparator | Group C in which 109 women continued their labour course without any further augmentation. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal bilirubin level
11/2015 to March 2016
Measured: 5 months.
Secondary outcomes (1)
neonatal APGAR score
11/2015 to 3 /2015
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sharkawy, Kasr El Aini Hospital
- Investigators
- Kasr El Ainy, Study director, kasr el ainy street,cairo,egyptmohamed el sharkawy, M.D., Principal investigator, 72 A Manial street,4thfloor.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602301
- Sponsor's protocol ID
- oxytocin
- Status last verified
- Nov 2015
- First submitted
- 8 Nov 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels .A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02602301
- Acronym / sponsor ID
- oxytocin
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Oxytocingroup A that included 109 women in whom labour was augmented by IV infusion of oxytocin using isotonic saline 0.9%, |
| 2 | Active comparator | Drug: Oxytocingroup B that included 109 women in whom labour was augmented by IV infusion of oxytocin using glucose 5% . |
| 3 | Placebo comparator | Drug: OxytocinGroup C in which 109 women continued their labour course without any further augmentation. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinondifferent oxytocin diluents and effect on fetal bilirubin\&sodium levels. | Drug | 1, 2, 3 |
Primary outcome
neonatal bilirubin level
Time frame: 5 months.
11/2015 to March 2016
1 secondary outcome
neonatal APGAR score
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
Related trials for Neonatal Hyperbilirubinemia
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Active, not recruiting
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasr El Ainy study director
kasr el ainy street,cairo,egypt
mohamed el sharkawy, M.D. principal investigator
72 A Manial street,4thfloor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Neonatal Hyperbilirubinemia, run by Kasr El Aini Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal bilirubin level (time frame: 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.