Changes in Pregnancy in Egyptian Women With History of Recurrent Miscarriage

NCT04960982 | Completed

• 1 other identifier: 'RMPCOS2021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 (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

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS Recurrent Miscarriage

Outcome Measures

Primary Outcomes (2)

• Cervical length changes during pregnancy

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

  9 months

• Androgens changes during pregnancy

  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

  9 months

Study Arms (3)

PCOS-RM

PCOS women with history of RM

Diagnostic Test: blood test

Non PCOS RM

Non PCOS women with history of RM

Diagnostic Test: blood test

Control

women with no history of RM

Diagnostic Test: blood test

Interventions

blood test DIAGNOSTIC_TEST

blood sample is taken in first, second and third trimester of pregnancy

Control; Non PCOS RM; PCOS-RM

Eligibility Criteria

• Age: 23 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Egyptian women

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead
• London Metropolitan University: collaborator

Study Sites (1)

Kafrelsheikh University

Cairo, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Essam El Mahdi, MD

  London Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 14, 2021
• Study Start: March 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: May 1, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

EG (1)