Clinical trial NCT06935422: Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications
Official title: Role of Cerebroplacental Ratio Discordance at 16-20 Weeks in Predicting Monochorionic Twin Pregnancies' Specific Complications : a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Monochorionic Twins
Cerebroplacental Ratio
Keywords: Monochorionic twins
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of monochorionic specific complications
timeFrame: From 16-20 weeks of gestation till delivery.
Secondary outcomes:
measure: Occurrence of intrauterine fetal death or perinatal mortality of one or both fetuses
timeFrame: From 16-20 weeks of gestation till 7th day of life
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Heba Abdelbaset Abd elkawy, Assistant professor
role: STUDY_CHAIR
affiliation: Ain Shams Maternity Hospital
name: Haitham Mohsen Elsabaa, Professor
role: STUDY_CHAIR
affiliation: Ain Shams Maternity Hospital
name: Amr Fathy Abd elkareem, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.