跳至主要内容
临床试验/NCT02380560
NCT02380560Unknown不适用

Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
latency interval as determined sonographic myometrial thickness

研究概览

简要总结

100 women divided into 3 groups:

  • Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
  • Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
  • Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.The myometrial thickness at 4 different sites9:

a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus was visualized.

(d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.

At least 3 measurements were obtained at each site and averaged. The latency interval is determined in each of the 3 groups.

详细描述

The total number of pregnant women enrolled in the study was 100 women. These were divided into three groups:

  • Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
  • Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
  • Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.Full History taking, including personal history for maternal age, obstetric history for number of previous pregnancies, history of previous PPROM. History of present pregnancy included gestational age, history of drug intake with special emphasis to women with PPROM giving history of gush of clear watery fluid from the vagina. Past history to exclude women with a contra- indication for conservative management in the study group.

Physical examinations: General examination for pulse, arterial blood pressure and temperature to exclude any signs of chorioamnionitis in the study group.

Abdominally, fundal level examinations for predicting the gestational age and/or IUGR or abnormalities of liquor. Monitoring of uterine contraction to pick up women who are not in labor in the study group.

P/V examination was not done for the three groups. While definite diagnosis of PPROM relied on sterile speculum examination showing a collection of fluid in the vagina. Some women needed direct observation of the cervix during a valsulva maneuver or with cough to show free flow of fluid from the cervical os.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • singleton pregnancy with a definite history of current PPROM for the study group

排除标准

  • Suspected fetal growth restriction (IUGR),
  • Any gross fetal anomalies,
  • Abnormalities of placentation,
  • Uterine structural abnormalities,
  • Fetal jeopardy or intrauterine fetal death (IUFD).
  • Women presenting with chorioamniointis with fever over 38 c abdominal tenderness, foul vaginal discharge and/or fetal tachycardia.
  • Diabetics, immunocompromized and cardiac patients.
  • Women with cervical cerclage.
  • Women with drained liquor

结局指标

主要结局

latency interval as determined sonographic myometrial thickness

时间窗: weeks in gestation

次要结局

  • neonatal Apgar(10 minutes after delivery)
  • neonatal ICU admission(24 hours after delivery)

研究者

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

Ahmed Maged

Assistant professor

Cairo University

研究点 (1)

Loading locations...

相似试验