NCT06935422

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2025Sep 2026

Study Start

First participant enrolled

March 1, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

March 12, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

Monochorionic twins

Outcome Measures

Primary Outcomes (1)

  • Development of monochorionic specific complications

    Monochorionic specific complications include twin to twin transfusion syndrome, twin anemia polycythemia sequence and selective fetal growth restriction

    From 16-20 weeks of gestation till delivery.

Secondary Outcomes (1)

  • Occurrence of intrauterine fetal death or perinatal mortality of one or both fetuses

    From 16-20 weeks of gestation till 7th day of life

Interventions

Measuring cerebroplacental ratio discordance in monochorionic twins at 16-20 Weeks of gestation

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aged 18 years or more and able to consent.
  • Monochorionic Diamniotic twin pregnancy.
  • Discordant inter-twin cerebroplacental ratio at 16-20 weeks of gestation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams maternity hospital

Cairo, Egypt

RECRUITING

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    PMID: 29920817BACKGROUND
  • 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.

    PMID: 25408721BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Heba Abdelbaset Abd elkawy, Assistant professor

    Ain Shams Maternity Hospital

    STUDY CHAIR
  • Haitham Mohsen Elsabaa, Professor

    Ain Shams Maternity Hospital

    STUDY CHAIR
  • Amr Fathy Abd elkareem, Professor

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

Central Study Contacts

Muhammed Ali Hassan, Assistant lecturer

CONTACT

Mohamed Sameh Elswaify, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 12, 2025

First Posted

April 20, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Name and email address

Shared Documents
STUDY PROTOCOL
Time Frame
From 2025 till 2028
Access Criteria
Any researcher, physician or university lecturer Access for full study content

Locations