NCT07551232

Brief Summary

To Evaluation of myocardial performance index in cases of fetal anemia

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started May 2026

Status
not yet 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 Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

April 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia

    Middle cerebral artery, MPI

    may 2026-May 2028

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Singleton pregnancy with raised MCA PSV MOM due to alloimmunization or Parvovirus infection will be invited to participate in the study. Institutional ethics committee approval will be gained and all women who participate in the study will gave an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Moise KJ Jr, Abels EA. Management of Red Cell Alloimmunization in Pregnancy. Obstet Gynecol. 2024 Oct 1;144(4):465-480. doi: 10.1097/AOG.0000000000005709. Epub 2024 Aug 15.

  • Hernandez-Andrade E, Lopez-Tenorio J, Figueroa-Diesel H, Sanin-Blair J, Carreras E, Cabero L, Gratacos E. A modified myocardial performance (Tei) index based on the use of valve clicks improves reproducibility of fetal left cardiac function assessment. Ultrasound Obstet Gynecol. 2005 Sep;26(3):227-32. doi: 10.1002/uog.1959.

  • Babkova A, Rob L, Kubecova M, Hruda M, Halaska MJ. Middle cerebral artery peak systolic velocity monitoring of fetal anemia during chemotherapy in pregnancy. Acta Obstet Gynecol Scand. 2024 Apr;103(4):660-668. doi: 10.1111/aogs.14759. Epub 2024 Jan 16.

  • Arslanoglu T, Bilirer KK, Uludag S, Arslan HC, Cetinkaya M, Dane BK, Polat I. The role of the Mod-MPI in identifying cardiac dysfunction in FGR fetuses stratified by umbilical artery flow abnormalities. BMC Pregnancy Childbirth. 2025 Sep 18;25(1):937. doi: 10.1186/s12884-025-08120-y.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for evaluation of Hb level and RH typing

Central Study Contacts

Naglaa mohammad, Assisatant lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share