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临床试验/NCT02846909
NCT02846909已完成2 期

The Effect of Adjunctive Use of Vaginal Progesterone After Cerclage on Prevention of 2nd Trimester Miscarriage

Assiut University1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2017年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
242
试验地点
1
主要终点
The frequency of spontaneous abortion before 28 weeks

研究概览

简要总结

Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be lost in the second trimester, which is much lower than in the first trimester. Once a pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.

Congenital fetal abnormalities and maternal anatomic factors as immunologic factors, infection, and thrombophilia should be considered; however, a reason and its result connection may be difficult to be established.

Cervical incompetence means that the cervix is weak and unable to remain closed during the pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to ascending infection may be more important.

Cervical cerclage is performed usually in women with a history of mid-trimester abortion or spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing recurrent loss.

Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians despite the absence of a well-defined population for whom there is clear evidence of benefit. Furthermore, there is little consensus on the optimal cerclage technique and timing and type of suture placement.

The Progesterone is known to have an inhibitory action on uterine contractility and is thought to play a main role in the maintenance of pregnancy until term. Progesterone is also able to modify the ultrastructural organisation of the myometrium by inhibiting the gap junctions, and preventing muscular contraction.

Different routes of administration of progesterone have been described in the literature. These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.

A recently published Cochrane review further confirmed the beneficial effects of progesterone in infant health following administration in women considered to be at increased risk of preterm birth due either to past history of preterm birth or when a short cervix was identified on ultrasound.

However; most of these published studies have been conducted to test the effect of progestational agents for the prevention of preterm labor not miscarriage.

Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth retardation and fetal anemia, and it plays an important role in managing of these conditions

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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age from 20 - 35 years old.
  • Pregnant from (12- 14 weeks) gestation.
  • Singleton pregnancy.
  • The pregnant women who have a history of second trimester pregnancy loss with painless cervical dilatation or have prior cerclage placement for cervical insufficiency or have a history of spontaneous preterm.

排除标准

  • Multiple gestations.
  • Congenital fetal malformation in the current pregnancy.
  • Women with history of thromboembolism or bleeding disorders.
  • Uncontrolled diabetes mellitus.
  • Chromosomal abnormalities affecting one of the couples.
  • Women refuse to participate in the study
  • Antiphospholipid syndrome

研究组 & 干预措施

Vaginal progesterone group

Active Comparator

Will receive progesterone pessaries 400 mg once daily vaginally

干预措施: Progesterone (Drug)

结局指标

主要结局

The frequency of spontaneous abortion before 28 weeks

时间窗: 14 weeks

number of women aborted before 28 weeks

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

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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