Breast Stimulation vs. Low Dose Oxytocin Augmentation for Women With a History of One Prior Cesarean Section Scar and in Grand Multiparas
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time interval from augmentation of labor to delivery
研究概览
简要总结
To find the preferred method of labor induction (birth augmentation) for women with a history of one prior cesarean section scar and in grandmultiparas, the difference in time interval from augmentation to delivery will be measured between breast stimulation vs. low-dose oxytocin administration in this prospective single-center randomized controlled trial.
详细描述
Introduction The primary cause of uterine scars is a previous cesarean. In women with a previous cesarean, the risks of maternal complications are rare and similar after a trial of labor after cesarean (TOLAC) and after an elective repeat cesarean delivery (ERCD), but the risk of uterine rupture is higher with TOLAC (0.2-0.8%)[1] . Maternal morbidity in women with previous cesareans is higher when TOLAC fails than when it leads to successful vaginal delivery[2]. Although maternal morbidity increases progressively with the number of ERCD, maternal morbidity of TOLAC decreases with the number of successful previous TOLAC[2].
Induction of labor is a common procedure undertaken whenever the benefits of prompt delivery outweigh the risks of expectant management. The goal of labor induction is to ensure the best possible outcome for mother and newborn[3].
For women after cesarean delivery labor should be induced only for medical indications[4]. Induction during TOLAC moderately increases the risk of cesarean delivery during labor, but approximately doubles the risk of uterine rupture compared with spontaneous labor in women with uterine scars[4].
Breast stimulation for inducing uterine contractions has been reported in the medical literature since the 18th century.
The American college of Obstetricians and Gynecologists (ACOG) has described nipple stimulation as a natural and inexpensive nonmedical method for inducing labor. Stimulation of the nipple by manual rolling of the nipple as well as by the breast pump has been used for performing contraction stress tests, induction or augmentation of labor and for reducing blood loss in the third stage of labor[5]. Nipple and uterine stimulation reduce the frequency of elective labor induction, the rate of relevant complications, and support normal vaginal birth by providing endogenous labor induction[6]. The mechanical uterotonic effect of breast stimulation is well recognized and described as a means of facilitating uterine contractions[7][8]. Breast stimulation can ripen the cervix in term pregnancy, seen as dilation and effacement, causing a change in Bishop score and increasing the incidence of spontaneous labor[9][10][11] A systematic review previously reported that breast stimulation for labor induction reduced the number of women who were not in labor after 72 h [12].
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton vertex gestations at or beyond 37 weeks of gestation
- •History of one prior cesarean section scar or grandmultipara (birth number 6 and above),
- •Spontaneous onset of labor or after labor induction by Foley balloon catheter, eligible for this trial
- •Determined by the obstetrics care team that augmentation was needed.
- •Augmentation will be initiated at or beyond 2.5 cm dilation, with or without ruptured membranes and uterine activity less than 3 contractions in 10 minutes on tocodynamometry.
排除标准
- •History of two prior cesarean section scars,
- •Younger than 18 years,
- •Any contraindication for vaginal birth (placenta previa, vasa previa, cord presentation, inadequate pelvis, prior uterine rupture),
- •Fetuses in nonvertex presentation
- •Fetuses with suspected life-limiting anomalies,
- •Suspected abruption or bleeding of unknown origin,
- •Women who did not agree to the enter the study.
结局指标
主要结局
Time interval from augmentation of labor to delivery
时间窗: up to 48 hours
次要结局
- Postpartum hemorrhage(during the first 24 hours after labor)
- Apgar score 3 or less at 5 minutes(during the first 5 minutes postpartum)
- Montevideo units in each group(active first and second stage of labor (up to 48 hours))
- Endometritis(during one week postpartum)
- rate of women who achieved vaginal delivery(during labor (48 hours))
研究者
Dr. Maya Wolf
Director of the Mother and Fetus Unit
Western Galilee Hospital-Nahariya