Monochorionic TwinsCPRNCT06935422
Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications
An observational study of Monochorionic Twins and Cerebroplacental Ratio, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the predictive value of CPR discordance at 16-20 weeks in MCDA twin pregnancies in predicting monochorionic-specific complications such as TTTS, TAPS, sFGR and IUFD of one or both fetuses Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Monochorionic Twins, Cerebroplacental Ratio
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: Monochorionic diamniotic twin pregnancies with discordant cerebroplacental ratio at 16-20 weeks of gestation presenting to Ain Shams University Maternity Hospital for antenatal care.
Who may be able to join
- Aged 18 years or more and able to consent.
- Monochorionic Diamniotic twin pregnancy.
- Discordant inter-twin cerebroplacental ratio at 16-20 weeks of gestation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Sameh Elswaify, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams maternity hospital
Cairo
Mohamed Swefy, Lecturer, +201285003060, muhammedali20241@gmail.com
About this study
Official title: Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications : a Prospective Cohort Study
The purpose of this study is to evaluate the predictive value of CPR discordance at 16-20 weeks in MCDA twin pregnancies in predicting monochorionic-specific complications such as TTTS, TAPS, sFGR and IUFD of one or both fetuses
Read the 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.
- Conditions
- Monochorionic Twins, Cerebroplacental Ratio
- Being tested
- Ultrasound
- Keywords
- Monochorionic twins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Measuring cerebroplacental ratio discordance in monochorionic twins at 16-20 Weeks of gestation
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of monochorionic specific complications
Monochorionic specific complications include twin to twin transfusion syndrome, twin anemia polycythemia sequence and selective fetal growth restriction
Measured: From 16-20 weeks of gestation till delivery.
Secondary outcomes (1)
Occurrence of intrauterine fetal death or perinatal mortality of one or both fetuses
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.
Measured: From 16-20 weeks of gestation till 7th day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Monochorionic TwinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Ali Hassan Ali, Ain Shams Maternity Hospital
- Investigators
- Heba Abdelbaset Abd elkawy, Assistant professor, Study chair, Ain Shams Maternity HospitalHaitham Mohsen Elsabaa, Professor, Study chair, Ain Shams Maternity HospitalAmr Fathy Abd elkareem, Professor, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935422
- Sponsor's protocol ID
- Monochorionic twins
- Acronym
- CPR
- Status last verified
- Aug 2025
- First submitted
- 12 Mar 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Name and email address
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.
PubMed 29920817Albu 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.
PubMed 25408721
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications : a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06935422
- Acronym / sponsor ID
- CPR / Monochorionic twins
- Conditions
- Monochorionic Twins, Cerebroplacental Ratio
- Keywords
- Monochorionic twins
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the predictive value of CPR discordance at 16-20 weeks in MCDA twin pregnancies in predicting monochorionic-specific complications such as TTTS, TAPS, sFGR and IUFD of one or both fetuses
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Monochorionic diamniotic twin pregnancies with discordant cerebroplacental ratio at 16-20 weeks of gestation presenting to Ain Shams University Maternity Hospital for antenatal care.
Key inclusion criteria (3 listed)
- Aged 18 years or more and able to consent.
- Monochorionic Diamniotic twin pregnancy.
- Discordant inter-twin cerebroplacental ratio at 16-20 weeks of gestation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundMeasuring cerebroplacental ratio discordance in monochorionic twins at 16-20 Weeks of gestation | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publicationJain 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.
- Results publication: PubMed 29920817Conde-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.
- Results publication: PubMed 25408721Albu 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.
- Individual participant dataSharing planned: Yes. Name and email address
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Sameh Elswaify, Lecturer contact
Heba Abdelbaset Abd elkawy, Assistant professor study chair
Ain Shams Maternity Hospital
Haitham Mohsen Elsabaa, Professor study chair
Ain Shams Maternity Hospital
Amr Fathy Abd elkareem, Professor study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monochorionic Twins and Cerebroplacental Ratio, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Ali Hassan, Assistant lecturer (+201020256117, muhammedali20191@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of monochorionic specific complications (time frame: From 16-20 weeks of gestation till delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.