跳至主要内容
临床试验/NCT00598260
NCT00598260终止不适用

Active Management Of Risk In Pregnancy At Term - a Prospective Study

Albert Einstein Healthcare Network2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2006年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
222
试验地点
2
主要终点
cesarean delivery rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

1- study group

Experimental

study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.

干预措施: induction of labor (Procedure)

2 - control group

No Intervention

control group

结局指标

主要结局

cesarean delivery rate

时间窗: prospective: 06.2006 to 06.2008

次要结局

  • admissions to NICU during same hospitalization(prospective. 06.2006 - 06.2008)
  • APGAR scores at one and five minutes(prospective. 06.2006 - 06.2008)
  • meconium(prospective. 06.2006 - 06.2008)

研究者

申办方类型
Other

研究点 (2)

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