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临床试验/NCT01501890
NCT01501890撤回不适用

The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding

Soroka University Medical Center1 个研究点 分布在 1 个国家开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
adverse pregnancy outcomes

研究概览

简要总结

The purpose of this study is to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes.

详细描述

First trimester vaginal bleeding is one of the most common pregnancy complications affecting 15-25% of all pregnancies. Threatened abortion is defined as bleeding through a closed cervical os in the first half of pregnancy. A subchorionic hematoma (SCH) is found in 18-39% of women with a threatened miscarriage and around 70% of women with a SCH will experience vaginal bleeding. Data on the relationship between first trimester vaginal bleeding and obstetric outcome is described mainly in retrospective and noncontrolled studies. It is hypothesized that first trimester bleeding is an indicator of a general tendency for complications (such as: preterm premature rupture of membranes (PPROM), preterm delivery (< 37 weeks gestation; PTD) low birth weight (<1500g; LBW) neonates, small for gestational age (SGA) neonates, placenta previa, placental abruption and stillbirth) later on in pregnancy.

Nowadays, there are not scientific based treatments for the prevention of complications associated with SCH and vaginal bleeding. Nevertheless, recent data have suggested that prophylactic administration of progesterone leads to a significant reduction in the rate of preterm deliveries and SGA neonates among patients with PTD or SGA neonates in the past. Although progesterone administration for threatened miscarriage was not studied, many physicians treat patients with first trimester vaginal bleeding with progesterone. In this era of evidence based medicine, the researchers aim to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes. The researchers hypothesize that treatment with progesterone for first trimester vaginal bleeding will alter the rates of the above mentioned obstetrical complications and adverse pregnancy outcomes.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Low risk pregnancies
  • Intrauterine pregnancy documented sonographically
  • Singleton pregnancy
  • Known gestational age
  • Healthy women

排除标准

  • Women after reproductive assistant techniques
  • Women treated with progesterone
  • Multiple pregnancies

研究组 & 干预措施

Progesterone

Active Comparator

Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation

干预措施: dihydroxyprogesterone caproate (Drug)

Placebo

Placebo Comparator

Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation.

干预措施: Placebo (Drug)

结局指标

主要结局

adverse pregnancy outcomes

时间窗: 9 months

Miscarriage (also gestational age of miscarriage) Sonographic Intrauterine hematoma IUGR Placenta previa Pregnancy induced hypertension and preeclampsia/eclampsia Gestational age at delivery - Preterm delivery (before 37w); Early Preterm delivery (before 34w); and very early (before 28w) Mode of delivery Placental abruption PPROM Induction of labor PPH Apgar score Umbilical cord blood PH at birth Birth weight Fetal malformations Perinatal mortality Admission to the neonatal unit

次要结局

  • Uterine artery blood flow velocimetry(One month after recruitment upon completion of treatment)
  • Placental pathological examination(After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days)

研究者

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

Adi Weintraub

Principal Investigator

Soroka University Medical Center

研究点 (1)

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