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Feto-Fetal Transfusion Syndrome in Multiple Pregnancies

NCT04148859 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-11-04

No results posted yet for this study

Summary

Objectives: Twin-to-twin transfusion syndrome (TTTS) generates high risk for one of the twins, may lead to preterm delivery and is also associated with neurodevelopmental deficits. The aim of this study was to explore a controlled amnioreduction (AR) procedure in which the amniotic pressure is simultaneously measured with the removed volume of amniotic pressure.

Methods: Eleven patients with severe TTTS at stages II and III of Quintero classification were enrolled to the study. The amniotic pressure was measured along with the removed volume of the amniotic pressure between 17-34 weeks of gestation. The umbilical artery S/D ratio for each twin was measured at the beginning and after every 500cc of removed amniotic fluid. Long-term neurodevelopmental outcome of infants with TTTS was evaluated from a questionnaire for assessing the overall health of the surviving twins.

Conditions

  • Pregnant With Complication

Interventions

PROCEDURE

amnioreduction

The amniotic fluid is drained via needle, which is stubbed in the abdomen wall, connected to a tube into a plastic bag. The amniotic fluid pressure will be measured by a water manometer. A T-shape connector will be connected to the tube on one side, and to a short tube on the other side. The height of the fluid within the short tube will indicate the pressure. All the fluid will be drained to the plastic bag. The pressure and the blood flow of the fetuses will be measured during the procedure, depends on the drainage rate.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ariel J Jaffa, MD · Ultrasound Unit in Obstetrics and Gynecology, Lis Maternity Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148859 on ClinicalTrials.gov