跳至主要内容
临床试验/NCT02602301
NCT02602301Unknown4 期

The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels .A Prospective Randomized Controlled Trial.

Kasr El Aini Hospital0 个研究点目标入组 327 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
327
主要终点
neonatal bilirubin level

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Active Comparator

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

干预措施: Oxytocin (Drug)

2

Active Comparator

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

干预措施: Oxytocin (Drug)

3

Placebo Comparator

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

干预措施: Oxytocin (Drug)

结局指标

主要结局

neonatal bilirubin level

时间窗: 5 months.

11/2015 to March 2016

次要结局

  • neonatal APGAR score(5 months)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed El-Sharkawy

kasr el ainy hospital,kasr el ainy street ,cairo egypt

Kasr El Aini Hospital

相似试验

The Effect of Intravenous Oxytocin Infusion Using... | 临床试验