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临床试验/NCT02694198
NCT02694198已完成不适用

Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2015年9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
135
试验地点
1
主要终点
Cervicovaginal Fetal Fibronectin Level

研究概览

简要总结

Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester abortion.

详细描述

The population of the study will comprise 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol.

Before entering the study, the purpose of this work will be clearly explained and verbal consent will be obtained from all patients enrolled in the study along with routine written informed consent as governed by the hospital rules.

All participants will be subjected to:

  1. History taking:

  2. Personal history: age and special habits

  3. Obstetric history (parity, history of abortions, previous cerculage and preterm labor). Gestational Age will be assigned by means of a combination of menstrual dating and ultrasonographic evaluation.

  4. Past medical history (hypersensitivity to misoprostol, chronic adrenal insufficiency and inherited porphyrias).

  5. Past history of previous cesarean section or other operations as hysterotomy and myomectomy.

  6. Examination:

研究设计

研究类型
Observational
观察模型
Case Only
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.
  • 14-24 weeks gestation..
  • Missed miscarriage

排除标准

  • History of pulmonary, hepatic, renal, or cardiovascular diseases.
  • History of previous cesarean section and other uterine surgeries as hysterotomy and myomectomy.
  • Inevitable abortion.
  • Placenta covering internal os.
  • History of any cervical surgery as cervical amputation, cauterization or dilatation.
  • Premature rupture of membranes.
  • Any vaginal bleeding.
  • Contraindications for misoprostol as hypersensitivity to misoprostol, chronic adrenal insufficiency and inherited porphyrias.

结局指标

主要结局

Cervicovaginal Fetal Fibronectin Level

时间窗: 72 hours

mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion

Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion

时间窗: 72 hours

Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)

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

Amr Ahmed Mahmoud Riad

Lecturer of obstetrics and gynecology

Ain Shams Maternity Hospital

研究点 (1)

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