Active Management Of Risk In Pregnancy At Term to Reduce Rate of Cesarean Deliveries
Active Management Of Risk In Pregnancy At Term - a Prospective Study
This is a prospective randomized cohort study of obstetric patients from Paley clinic at AEMC and from other affiliated obstetric clinics.
This study will try to determine if active management of risks in pregnancy at term by inducing patients will not decrease the cesarean delivery rate or change neonatal outcomes.
The outcomes that will be measured include cesarean delivery rate, meconium, Apgar scores and admissions to the NICU.
研究概览
详细说明
The study will include patients who have their prenatal care at the Paley clinic in AEMC, where the residents provide the prenatal care with supervision of OBGYN attending physicians, or at other affiliated clinics that are staffed by care givers from our OBGYN department.
Patients at our obstetric clinics are scheduled for weekly visits starting at 36 weeks. At 36 to 37 weeks of gestation, or earlier, each patient will be offered to participate in the study. Those who refuse will continue to have the standard care and will not be considered as part of the study. Those who wish to participate in the study will be consented and will then be randomly assigned to the control group or to the AMOR-IPAT group with a ratio of 2:1.
Risk factors will be identified for each patient participating in the study at the gestational age of 36 to 37 weeks (using the digichart system, the medical records and questioners) and the upper limit of the optimal time of delivery will be calculated for each patient, according to the method used by the UPenn group, with the time always being at least 38 weeks and no more then 41 weeks.
Patients from the AMOR-IPAT group will be scheduled for induction of labor on the morning of the day of the calculated upper limit (plus or minus 2 days).
To try and eliminate biases, a uniform method of induction will be applied to all the patients participating in the study, no matter the group or the reason for the induction. The induction will be performed with misoprostol 25mcg intravaginally every four hours (to a maximum of three doses) for a Bishop score of 4 or less and as long as there is no tachysystole which will be defined as six or more uterine contractions in ten minutes in consecutive ten minute intervals. The misoprostol will be followed by a foley bulb inflated with 80 cc of fluid if the cervix is still not favorable after three doses or when tachysystole develops. Once the cervix is favorable induction will be continued with high dose oxytocin (starting dose of six milliunits with increments of four milliunits every thirty minutes), which is associated with less cesarean deliveries for dystocia than the low dose.
Anesthesia will be applied according to the patient's wish, without limiting epidural anesthesia to a certain degree of dilatation.
After delivery information will be collected from the charts and the two groups will be compared regarding the incidence of cesarean deliveries, but also regarding intrapartum variables and major outcomes.
The Student t test and the Wilcoxon rank sum test will be used to compare continuous demographic characteristics, past medical and surgical historic features and obstetric risk factors that will be present in the two study groups. Universal chi squared tests will be used to compare levels of various dichotomous variables.
Statistical significance is defined as a probability value of less than 0.05. Using a power analysis and by assuming a cesarean delivery rate of 20% in the control group and a change of 13% (as shown in the original study) we will need 191 patients in the control group and 96 in the study group.
All data will be collected by staff of the OBGYN department and maintained on departmental secured password limited database. Obstetrical prenatal data is maintained on HIPPA compliant password protected electronic medical records.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19141
- Albert Einstein Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with singleton pregnancies
- at least one prenatal visit at one of our clinics
- an ultrasonogram confirming the dates within the first 22 weeks
- no maternal or fetal problems before 37 weeks and 5 days of gestation that mandated cesarean delivery.
Exclusion Criteria:
- a delivery before 37 weeks and 5 days of gestation
- a previous cesarean delivery (one or more)
- a history of any other uterine surgeries that are a contraindication for a vaginal delivery.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1- study group
study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
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study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
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无干预:2 - control group
control group
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
cesarean delivery rate
大体时间:prospective: 06.2006 to 06.2008
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prospective: 06.2006 to 06.2008
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次要结果测量
结果测量 |
大体时间 |
---|---|
admissions to NICU during same hospitalization
大体时间:prospective. 06.2006 - 06.2008
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prospective. 06.2006 - 06.2008
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APGAR scores at one and five minutes
大体时间:prospective. 06.2006 - 06.2008
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prospective. 06.2006 - 06.2008
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meconium
大体时间:prospective. 06.2006 - 06.2008
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prospective. 06.2006 - 06.2008
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合作者和调查者
调查人员
- 学习椅:Arnold Cohen, MD、Albert Einstein Medical Center
- 首席研究员:Shai M Pri-Paz, MD、Albert Einstein Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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