- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06935422
Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications (CPR)
Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications : a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Monochorionic (MC) twin pregnancies are at a higher risk of perinatal morbidity and mortality because of the risk of developing unique complications. These include twin to twin transfusion syndrome (TTTS), selective fetal growth restriction (sFGR) , twin anemia polycythemia sequence (TAPS) and intrauterine fetal death (IUFD) of one or both fetuses. Therefore, early identification of these conditions is warranted to plan proper perinatal surveillance and management to improve outcome.
Sparse studies have found that inter-twin differences in Doppler ultrasound may occur prior to meeting diagnostic criteria for TTTS, TAPS, sFGR or adverse perinatal outcomes.
This study will try to reveal the potential clinical predictive value of inter-twin cerebroplacental ratio (CPR) discordance in the surveillance of MC twin pregnancies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Muhammed Ali Hassan, Assistant lecturer
- Phone Number: +201020256117
- Email: muhammedali20191@yahoo.com
Study Contact Backup
- Name: Mohamed Sameh Elswaify, Lecturer
- Phone Number: +201285003060
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Ain Shams Maternity Hospital
-
Contact:
- Mohamed Swefy, Lecturer
- Phone Number: +201285003060
- Email: muhammedali20241@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 years or more and able to consent.
- Monochorionic Diamniotic twin pregnancy.
- Discordant inter-twin cerebroplacental ratio at 16-20 weeks of gestation.
Exclusion Criteria:
- Fetal structural malformations or chromosomal abnormalities in any of the twins as detected by anomaly scan antenatally or neonatal examination postnatally (chromosomal abnormalities and some congenital malformations can interfere with normal fetal growth).
- Identified infectious etiologies detected during immediate postnatal examination or during pregnancy (fetal infections can cause FGR ,usually symmetric type particularly if they occur in early gestation).
- Referral after development of Twin to twin transfusion syndrome, twin anemia polycythemia sequence or selective fetal growth restriction.
- Single fetal demise at the time enrollment in the study.
- Conjoint twins.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of monochorionic specific complications
Time Frame: From 16-20 weeks of gestation till delivery.
|
Monochorionic specific complications include twin to twin transfusion syndrome, twin anemia polycythemia sequence and selective fetal growth restriction
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From 16-20 weeks of gestation till delivery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of intrauterine fetal death or perinatal mortality of one or both fetuses
Time Frame: From 16-20 weeks of gestation till 7th day of life
|
Gestational age upon occurrence of IUFD with clarifying if complications occur in the surviving twin in case of single fetal demise.
Time and reason of perinatal mortality for any of the fetuses Wil be recorded.
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From 16-20 weeks of gestation till 7th day of life
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Heba Abdelbaset Abd elkawy, Assistant professor, Ain Shams Maternity Hospital
- Study Chair: Haitham Mohsen Elsabaa, Professor, Ain Shams Maternity Hospital
- Study Director: Amr Fathy Abd elkareem, Professor, Ain Shams Maternity Hospital
Publications and helpful links
General Publications
- Jain A, Acharya V, Shettikeri A, Sahana R, Radhakrishnan P. Intertwin discordance in MCA-PI and CPR in the prediction of TTTS progression. 19th world congress in fetal medicine. Ultrasound Obstet Gynecol. 2022;1(1):5-9.
- Conde-Agudelo A, Villar J, Kennedy SH, Papageorghiou AT. Predictive accuracy of cerebroplacental ratio for adverse perinatal and neurodevelopmental outcomes in suspected fetal growth restriction: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Oct;52(4):430-441. doi: 10.1002/uog.19117. Epub 2018 Sep 5.
- Albu AR, Anca AF, Horhoianu VV, Horhoianu IA. Predictive factors for intrauterine growth restriction. J Med Life. 2014 Jun 15;7(2):165-71. Epub 2014 Jun 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Monochorionic twins
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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