Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time from the start of oxytocin to delivery
研究概览
简要总结
The goal of this clinical trial is to compare between higher and lower dose of oxytocin to induce delivery in obese women. Researches will compare between low and high doses of oxytocin. the study group will use high dose of oxytocin (20 units in 1000 ml) versus the control group which will use low dose of oxytocin (10 units of oxytocin in 1000 ml)
详细描述
the duration and the progression of the first stage of labor is slower in obese women and oxytocin seems to be less effective in the treatment of protracted labor in obese women. There is no consensus in the literature about the optimal oxytocin dose. Hence, the objective of this study is to compare 2 oxytocin regimens, low VS high dose among obese women who need induction or augmentation of labor.
Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor. Who are obese (BMI 30 and above), Viable singleton pregnancies with Cephalic presentation. After their consent, will be randomization: in a 1:1 allocation.
Group 1 (control) will receive a low dose- 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
Group 2 (study) will receive a high dose- 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
The primary outcome of the study is the time from the start of oxytocin to delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor.
- •BMI 30 and above
- •Viable singleton pregnancies
- •Cephalic presentation.
- •No contraindication for vaginal delivery
排除标准
- •Women with previous cesarean delivery
- •Multiple pregnancy
- •Multiple fetal malformations
研究组 & 干预措施
High dose oxytocin
This arm of the study will receive high dose oxytocin - 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
干预措施: Oxytocin Grindeks 10 IU/ml- solution for injection (Drug)
Low dose oxytocin
This arm of the study will receive low dose oxytocin- - 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
干预措施: Oxytocin Grindeks 10 IU/ml- solution for injection (Drug)
结局指标
主要结局
Time from the start of oxytocin to delivery
时间窗: from the start of induction till delivery
our hypothesis that high dose of oxytocin shortens the time from the start of induction to delivery
次要结局
- Maternal satisfaction(will be assessed up to 1 day after delivery)
- Neonatal outcomes(up to 1 week)
- Apgar score(at 1, 5 and 10 minutes)
- GTPAL system(at enrollment)
- maternal weight(at enrollment)
- maternal height(at enrollment)
- mode of delivery(at delivery)
- Maternal age(at enrollment)
- uterine rupture(up to 6 weeks after delivery)
- perineal tears(during delivery)
- intrapartum fever(during labor)
- PPH(up to 6 weeks)
- length of postpartum stay(perinatal.)
研究者
Rola Iskander
Dr Rula Iskander - ObGyn resident and official investigator
HaEmek Medical Center, Israel