Feto-Fetal Transfusion Syndrome in Multiple Pregnancies

NCT04148859 | Unknown DMC

• 1 other identifier: 04-220
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TTTS; controlled amnioreduction; amniotic pressure

Outcome Measures

Primary Outcomes (1)

• The amniotic pressure

  The amniotic fluid pressure will be measured at the beginning and after every 500cc of removed amniotic fluid by a water manometer. The pattern of the decreasing amniotic pressure during removal of the excess volume of fluid will be depicted.

  The duration of measurements will be about 80 minutes per procedure.

Secondary Outcomes (2)

• The removed amniotic volume

  The duration of measurements will be about 80 minutes per procedure.

• The umbilical artery S/D ratio

  The duration of measurements will be about 80 minutes per procedure.

Study Arms (1)

pregnant women

EXPERIMENTAL

women who have to undergo amnioreduction due to TTTS

Procedure: amnioreduction

Interventions

amnioreduction PROCEDURE

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.

pregnant women

Eligibility Criteria

• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancies with TTTS

You may not qualify if:

• Pregnancies with malformations or genetic pathologies

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Zoya Gordon

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ariel J Jaffa, MD

  Ultrasound Unit in Obstetrics and Gynecology, Lis Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoya Gordon, PhD

CONTACT

972-3-692-5759; zoyag@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: We will recruit 11 women who have to undergo amnioreduction due to TTTS. 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. We will include cases of multiple pregnancies with TTTS who must undergo amnioreduction.

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2004
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

IL (1)