Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04960982
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-07-09
Brief Title:
Changes in Pregnancy in Egyptian Women With History of Recurrent Miscarriage
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Changes in Testosterone SHBG DHEA and Cervical Length During Pregnancy in Egyptian Women With History of Recurrent Miscarriage
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 n38 and without n40 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 n40 HC were also recruited TT SHBGDHEA 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
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 n38 and without n40 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 n40 HC were also recruited TT SHBGDHEA 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
Detailed Description:
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 2of women Jeve et al 2014 Green-top Guideline No 17Other studies have reported incidences of RM between 05 and 23 Christiansen et al2007 Stirrat et al 1990 Alberman et al 1988
Currently the established risk factors of RM include hormonal associated conditions Stephenson et al1996 Fox-Lee et al 2007 uterine abnormalities including adhesions post-surgery Rimbizis et al2001 Salim et al2003 anti-phospholipid syndrome Thrombotic Greer et al 2003 chromosomal and genetic Braekeleer et al 1990 Clifford et al1994 Stephenson et al 2006 Franssen et al 2006 conditions Indeed some researchers consider PCOS as a risk factor However some dont
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 al2013
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
Cervical cerclage CC is one of the management options offered to patient who has history of midterm miscarriage The efficacy of CC in management is still doubtable
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 women with and without history PCOS and history of RM during pregnancy
Subjects and Methods
- Subjects
Participants of the study are women with n38 and without PCOS n40 and history of RM were recruited during their first antenatal visit from Al-Agoza Hospital Cairo Egypt They were recruited during their first antenatal visit Similarly pregnant women without PCOS n40 with no history of RM were recruited Detailed demographic medical and obstetric history was documented
The inclusion criteria for the study were women aged 23 to 40 years at the time of enrolment into the study The exclusion criteria for all participants included any other diagnosed medical condition link with increased risk of miscarriage including thyroid status and gestational diabetes All participants examined at the time of recruitment
The control group were matched for age and BMI with no previous history of RM
This study was conducted in line with the human experimentation guidelines dictated by the Helsinki declaration The procedures used were approved by local ethical committee and conducted in line with the practices of Al-Agoza Hospital Cairo Egypt All patients within the study were briefed on the procedures and protocol that would take place and written consent was obtained before induction into the study
- Methods
Confirmation of the pregnancy was made by beta-human chorionic gonadotrophin Bhcg plus ultrasound scan and clinical history in case of miscarriage
Diagnosis for patients with recurrent miscarriage was in concordance with the guidelines defined by the Royal College of Obstetricians and Gynaecologists the loss of three or more consecutive pregnancies Royal College of Obstetricians Gynaecologists 2011 The diagnosis of PCOS was based on Rotterdam 2003 Criteria Rotterdam ESHREASRM-Sponsored PCOS Consensus Workshop Group 2004 which require two of the following Oligo- or anovulation Clinical andor biochemical signs of hyperandrogenism or Polycystic ovaries and exclusion of other related disorders
Blood Samples were collected by a professional trained in phlebotomy at the time points first second and the third trimester or at the start of miscarriage Samples were analysed for TT SHBGSHBG and DHEA using The ADVIA Centaur XPT Immunoassay System - Siemens httpswwwsiemens-healthineerscomen-ukimmunoassaysystemsadvia-centaur-xptTECHNICAL_SPECIFICATIONSThis system is easy to use where samples and reagents which could be loaded or without pausing the system Also it doesnt require daily set up procedure and implement new assays immediately with one easy scan of a test definition bar code
It requires 10-200 μL per test it offers Automatic dilution varies by assay up to 12500 The reagent capacity on board is 30 assays
Similarly cervical length was also measured at first second and the third trimester or at the start of miscarriage It was measured via transvaginal ultrasound Berghella et al1997 The Voluson E8 ultrasound system is used for this study httpswwwgehealthcarecomproductsultrasoundvolusonvoluson-e8 The data was recorded by measuring the distance between the external os of the cervix and to where the cervix is closed defined by the apex of the funnelling of the membranes Berghella et al 1997
All patients within the RM groups attended cerclage treatment during the second trimester this included elective and emergency elective procedures Patients presented at the time of delivery or for recording of miscarriage where gestational age gender of the fetusbaby and whether it was a live birth was noted
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 2of women Jeve et al 2014 Green-top Guideline No 17Other studies have reported incidences of RM between 05 and 23 Christiansen et al2007 Stirrat et al 1990 Alberman et al 1988
Currently the established risk factors of RM include hormonal associated conditions Stephenson et al1996 Fox-Lee et al 2007 uterine abnormalities including adhesions post-surgery Rimbizis et al2001 Salim et al2003 anti-phospholipid syndrome Thrombotic Greer et al 2003 chromosomal and genetic Braekeleer et al 1990 Clifford et al1994 Stephenson et al 2006 Franssen et al 2006 conditions Indeed some researchers consider PCOS as a risk factor However some dont
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 al2013
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
Cervical cerclage CC is one of the management options offered to patient who has history of midterm miscarriage The efficacy of CC in management is still doubtable
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 women with and without history PCOS and history of RM during pregnancy
Subjects and Methods
- Subjects
Participants of the study are women with n38 and without PCOS n40 and history of RM were recruited during their first antenatal visit from Al-Agoza Hospital Cairo Egypt They were recruited during their first antenatal visit Similarly pregnant women without PCOS n40 with no history of RM were recruited Detailed demographic medical and obstetric history was documented
The inclusion criteria for the study were women aged 23 to 40 years at the time of enrolment into the study The exclusion criteria for all participants included any other diagnosed medical condition link with increased risk of miscarriage including thyroid status and gestational diabetes All participants examined at the time of recruitment
The control group were matched for age and BMI with no previous history of RM
This study was conducted in line with the human experimentation guidelines dictated by the Helsinki declaration The procedures used were approved by local ethical committee and conducted in line with the practices of Al-Agoza Hospital Cairo Egypt All patients within the study were briefed on the procedures and protocol that would take place and written consent was obtained before induction into the study
- Methods
Confirmation of the pregnancy was made by beta-human chorionic gonadotrophin Bhcg plus ultrasound scan and clinical history in case of miscarriage
Diagnosis for patients with recurrent miscarriage was in concordance with the guidelines defined by the Royal College of Obstetricians and Gynaecologists the loss of three or more consecutive pregnancies Royal College of Obstetricians Gynaecologists 2011 The diagnosis of PCOS was based on Rotterdam 2003 Criteria Rotterdam ESHREASRM-Sponsored PCOS Consensus Workshop Group 2004 which require two of the following Oligo- or anovulation Clinical andor biochemical signs of hyperandrogenism or Polycystic ovaries and exclusion of other related disorders
Blood Samples were collected by a professional trained in phlebotomy at the time points first second and the third trimester or at the start of miscarriage Samples were analysed for TT SHBGSHBG and DHEA using The ADVIA Centaur XPT Immunoassay System - Siemens httpswwwsiemens-healthineerscomen-ukimmunoassaysystemsadvia-centaur-xptTECHNICAL_SPECIFICATIONSThis system is easy to use where samples and reagents which could be loaded or without pausing the system Also it doesnt require daily set up procedure and implement new assays immediately with one easy scan of a test definition bar code
It requires 10-200 μL per test it offers Automatic dilution varies by assay up to 12500 The reagent capacity on board is 30 assays
Similarly cervical length was also measured at first second and the third trimester or at the start of miscarriage It was measured via transvaginal ultrasound Berghella et al1997 The Voluson E8 ultrasound system is used for this study httpswwwgehealthcarecomproductsultrasoundvolusonvoluson-e8 The data was recorded by measuring the distance between the external os of the cervix and to where the cervix is closed defined by the apex of the funnelling of the membranes Berghella et al 1997
All patients within the RM groups attended cerclage treatment during the second trimester this included elective and emergency elective procedures Patients presented at the time of delivery or for recording of miscarriage where gestational age gender of the fetusbaby and whether it was a live birth was noted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None