Induction of Labor With Oxytocin: When Should Oxytocin be Held?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Cesarean Delivery
研究概览
简要总结
The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol.
One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and then maintained at the same level throughout labor. The second arm will follow an oxytocin protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine hyperstimulation, maternal and neonatal outcomes.
As mentioned in the study proposal, the proposed experimental arm is currently not performed as part of the oxytocin guidelines at the investigators' institution. One study from Israel suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some providers stop the oxytocin in active labor for their patients, this is not a commonly performed procedure at the investigators' institution. The investigators are not aware of other institutions employing the above practice.
详细描述
Oxytocin is the most common agent used to induce and augment labor. Oxytocin injection is approved by the Food and Drug Administration for the initiation or improvement of uterine contractions to achieve vaginal delivery. It is used to induce labor and stimulate or reinforce labor.
The relationship of oxytocin and its receptor is crucial in obtaining adequate uterine activity and thus inducing active labor. Due to this very balanced relationship, a question exists about the optimal regimen of oxytocin administration for induction of labor and on how long to continue oxytocin once active labor begins. Some literature suggests that once in the active phase of labor oxytocin may be discontinued without altering the progression of labor. The objective of this study is to determine whether there is an increased rate of cesarean delivery in women undergoing induction of labor when oxytocin is discontinued in the active phase of labor.
Blair-Bell was the first who, in 1909, demonstrated the uterotonic action of posterior pituitary extracts at a cesarean delivery. Since then oxytocin, synthesized by du Vigneaud et al, has been most commonly used for the induction of labor. Oxytocin (OT) is a polypeptide hormone, synthesized in the hypothalamus and in reproductive tissues during pregnancy.
Oxytocin stimulates uterine contraction by mechanisms involving the activation of receptor-operated calcium channels. Calcium-dependent phosphorylation of myosin triggers the interaction of myosin and actin subunits throughout the uterus leading to contractions.
During labor and parturition the relationship between oxytocin and its receptor is critical in achieving adequate uterine contractions and thus active labor. If few receptors are present, as seen in an early gestation, a large amount of OT is required for contractions. The opposite is true in term pregnancy. OT binding to its receptor is very important because excess doses of OT are not productive and may have undesirable effects.
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
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Candidates for the study are pregnant women (with one fetus) scheduled for induction of labor with oxytocin at term gestation or greater, regardless of the indication for induction, bishop score (cervical dilation) or parity.
排除标准
- •Exclusions include women with multiple gestations, previous cesarean sections, and documented fetal anomalies.
- •Women with contraindications to labor or induction will also be excluded.
研究组 & 干预措施
Oxytocin
Continuation of oxytocin per protocol once the patient reaches active labor
干预措施: Oxytocin (Drug)
Oxytocin discontinuation
Oxytocin will be stopped once the patient reaches active labor
干预措施: Oxytocin discontinuation (Drug)
结局指标
主要结局
Cesarean Delivery
时间窗: 24-72 hours from admission for induction
Mode of delivery is the primary outcome
次要结局
- Perinatal Outcomes(24-72 hours)
研究者
Joanne Quinones, MD
Attending Physician
Lehigh Valley Hospital