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临床试验/NCT04960982
NCT04960982已完成不适用

Changes in Testosterone, SHBG, DHEA and Cervical Length During Pregnancy in Egyptian Women With History of Recurrent Miscarriage

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 40 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
状态
已完成
入组人数
40
试验地点
1
主要终点
Androgens changes during pregnancy

研究概览

简要总结

Introduction: Elevated levels of androgen and insulin-resistant have been implicated in recurrent miscarriage in women with PCOS. Published data are scarce on androgen level and cervical length of women with and without PCOS and a history of miscarriage.

Aim: The aim of this study was to investigate the levels of testosterone (TT), Sex Hormone Binding Globulin (SHBG), Dehyroepiandrostenedione (DHEA) and cervical length in Egyptian women with and without history PCOS and history of RM during pregnancy .

Method: Pregnant women with (n=38) and without (n=40) PCOS and history of recurrent miscarriages were recruited from the Obstetrics Department, Alagoza Hospital, Cairo, Egypt. Healthy pregnant women without PCOS and history of RM (n=40, HC) were also recruited. TT, SHBG,DHEA and Sex Hormone Binding Globulin (SHBG) level and cervical length were assessed at first, second and the third trimester or at the start of miscarriage

详细描述

Introduction

Recurrent miscarriage (RM )is defined as the loss of three of more consecutive pregnancies before 20 weeks gestation (Royal College of Obstetricians & Gynaecologists 2011, Practice Committee of American Society for Reproductive Medicine 2013). The prevalence of RM varies from country to country and within communities within the country. It tends to be higher in developing countries. However it effects 1% to 2%of women (Jeve et al., 2014, Green-top Guideline No. 17).Other studies have reported incidences of RM between 0.5% and 2.3 % (Christiansen et al.,2007, Stirrat et al., 1990, Alberman et al., 1988).

Currently the established risk factors of RM include hormonal associated conditions (Stephenson et al.,1996, Fox-Lee et al., 2007) , uterine abnormalities (including adhesions post-surgery) (Rimbizis et al.,2001, Salim et al.,2003) anti-phospholipid syndrome Thrombotic (Greer et al., 2003) , chromosomal and genetic (Braekeleer et al., 1990 , Clifford et al.,1994, Stephenson et al., 2006, Franssen et al., 2006) conditions .Indeed some researchers consider PCOS as a risk factor, However some don't.

Approximately 8% to 12% of RM is due to endocrine causes mainly due to hyperandrogenism and hyperinsulinemia in PCOS (Smith et al., 2011, Witchel et al., 2019, Rai et al., 2000) . Little research focuses directly on the effect of PCOS during gestation and how that can be linked to poor pregnancy outcomes. However, there is a positive correlation between increased risk of miscarriage and hyperhomocysteinemia in insulin resistant patients, a common component of PCOS (Chakraborty et al.,2013).

The current literature providing conflicting views on androgen levels effecting pregnancy in PCOS patients some clarity is required as to whether its elevation impacts pregnancy. Not only that, but the is limited published data which compared the androgen and cervical length at different gestational periods of women with history of miscarriage either due to PCOS or for unknown reasons.

研究设计

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

入排标准

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

入选标准

  • women aged 23 to 40 years at the time of enrolment into the study. The exclusion criteria for all participants included

排除标准

  • Any other diagnosed medical condition link with increased risk of miscarriage, including thyroid status and gestational diabetes

结局指标

主要结局

Androgens changes during pregnancy

时间窗: 9 months

TT, SHBG,DHEA and Sex Hormone Binding Globulin (SHBG) level were assessed at first, second and the third trimester or at the start of miscarriage

Cervical length changes during pregnancy

时间窗: 9 months

Cervical length is shorter in recurrent miscarriage groups at the start of the study and getting shorter during pregnancy

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

Dr Essam El Mahdi

Dr

Kafrelsheikh University

研究点 (1)

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