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临床试验/NCT01773135
NCT01773135已完成不适用

Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
1
主要终点
Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor

研究概览

简要总结

The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .

详细描述

This is a cross sectional study that will include 261 pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor and consented to participate in this study. This study will be conducted at Ain Shams University Maternity Hospital after approval of the research and ethics committee.

the investigators include all patients which have these following criteria (Singleton pregnancy, Age between 17 - 35 years, Gestational age between 28 and 36 weeks and Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.

the investigators exclude any patient which has any of the following criteria (Preterm rupture of membranes, Any uterine anomalies or cervical incompetence, Chronic illness such as chronic hypertension or kidney disease, Diabetes mellitus, Abruptio placenta, Preeclampsia and HELLP syndrome, Fetal anomalies, IUGR, Smoking or Clinical signs of intrauterine infection).

blood sample was collected from each patient for measurement of ACTH level. According to local protocol in Ain Shams University Maternity Hospital all women will receive a fixed regimen of tocolysis in the form of nifedipine (Epilat) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.

After delivery, the investigators divide the patients into 2 groups (full term delivery & preterm delivery) and we compare between these 2 groups by level of hormone.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
17 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • Age between 17 - 35 years.
  • Gestational age between 28 and 36 weeks.
  • Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.

排除标准

  • Preterm rupture of membranes.
  • Any uterine anomalies or cervical incompetence.
  • Chronic illness such as chronic hypertension or kidney disease.
  • Diabetes mellitus.
  • Abruptio placenta.
  • Preeclampsia and HELLP syndrome.
  • Fetal anomalies.
  • Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).

结局指标

主要结局

Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor

时间窗: 9 weeks

measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Saied Eldein El-Safty

Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University

Ain Shams Maternity Hospital

研究点 (1)

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