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Neonatal Outcome for Laser Coagulation in Twin-to-twin-transfusion Syndrome

This study is currently recruiting participants.
Verified May 2017 by Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg
Sponsor:
ClinicalTrials.gov Identifier:
NCT03151915
First Posted: May 12, 2017
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg
  Purpose
Twin-twin transfusion syndrome is one of the most severe complication in monochorionic twin pregnancies and can cause severe impairment of fetal and neonatal outcome. In severe TTTS the fetoscopic laser coagulation is the treatment of choice. Fetoscopic laser coagulation is associated with a morbidity and mortality due to iatronic rupture of membranes as well as iatrogenic placenta insufficiency. This can cause preterm delivery as well as intrauterine fetal demise. An adaption of the fetoscopic tools to reduce the lesions of the amniotic membrane can decrease the risk of PPROM and increase the overall survival.

Condition
TTTS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neonatales Outcome Nach Intrauteriner Laserablation Mit 1.0mm-Optik Bei Fetofetalem Transfusionssyndrom

Resource links provided by NLM:


Further study details as provided by Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • postoperative neonatal survival [ Time Frame: 48 hours after fetoscopic surgery ]
    rate of intrauterine demise until demission

  • Gestational Age at delivery [ Time Frame: at delivery ]
    average gestational Age at delivery

  • Long term neonatal survival [ Time Frame: fetoscopic surgery until delivery ]
    rate of fetal demise until delivery


Secondary Outcome Measures:
  • Child's survival after fetoscopic laser coagulation [ Time Frame: one minute after delivery ]
    • at least one child survives
    • both children survive
    • intrauterine foetal death of both children

  • Premature rupture of membranes [ Time Frame: 48 hours after fetoscopic surgery ]
  • Reoccurrence of TTTS after the procedure [ Time Frame: 48 hours after fetoscopic surgery ]

Estimated Enrollment: 100
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 1, 2017
Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients who underwent fetoscopic laser coagulation with TTTS
This is an retrospektive trial. We use data of patients who underwent fetoscopic laser coagulation with TTTS retrospectively. All patients meet eligibility criteria and give written informed consent before therapy. As part of the ongoing quality control we were able to safely store patient data relating to fetoscopic laser coagulation with TTTS.

Detailed Description:

Twin-twin transfusion syndrome (TTTS) occurs in approximately 15% of monochorionic pregnancies. The disease is thought to result from unbalanced intertwin blood flow between the donor and the recipient twin through placental vascular anastomoses. Untreated, TTTS is associated with high perinatal mortality and morbidity.

Fetoscopic laser photocoagulation of the vascular anastomoses is currently the best treatment option for TTTS. The aim of laser surgery is to separate completely both fetal circulations by occluding all placental vascular anastomoses.

However, at the same time the fetoscopic procedure can cause injury to the amniotic membrane. This injury will last until childbirth, as the fetal membrane's capability to repair is restricted. This can lead to preterm premature rupture of membranes (PPROM) and in some cases even to fetal loss.

Decreasing the diameter of fetoscopic instruments can reduce injury to the amniotic membrane. At University Hospital Halle/Saale a new ultrathin fetoscpoes with 1.0/1.2 mm optic is used to reduce sheath sectional area from 3.8/4.3 mm (13F) to 2.3mm (7F).

In 2011 the author published a retrospective cohort study of the first results of laser coagulation using 1.0/1.2 mm optic on 27 female patients. The data was compared to the results using 2.0 mm optic on 53 female patients. The comparison brought to light that the survival rate of at least one twin was 97% (compared to 94.4% using classic optic) and 83.3% (75.5%) for both twins surviving. At the same time the use of the ultrathin optic increased the length of pregnancy by 21.3 days, increased the recipient's weight by 389g and also the donor's Apgar score.

On the other hand, donor's weight and recipient's Apgar score remained unchanged. The results also did not show a decrease in the rate of premature rupture of membranes or a decrease in re-TTTS.

The Authors expect to show more advantages using a wider sample size. The data will be analysed adhering to strict quality protocols. This will hopefully allow us to demonstrate our succesful clinical experience with fetoscopic laser photcoagulation for TTTS using a 1.0 mm endoscope.

A retrospective analyse of all data of patients who underwent fetoscopic laser coagulation with TTTS will be performed retrospectively. As part of the ongoing quality control the authors were able to safely store patient data relating to fetoscopic laser coagulation with TTTS. The plan is to compare results using 1.0/1.2 mm optic with 2.0 mm optic.

Planned study areas inlcude gestational age at birth, the child's survival after fetoscopic laser coagulation (at least one child survives, both children survive, intrauterine foetal death of both children), as well as premature rupture of membranes and reoccurrence of TTTS after the procedure.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
All pregnant women with TTS
Criteria

Inclusion Criteria:

  • Clinical diagnosis of TTTS
  • Ability to give informed consent in german or english

Exclusion Criteria:

  • Missing informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151915


Contacts
Contact: Michael Tchirikov, Professor Dr. med. michael.tchirikov@uk-halle.de

Locations
Germany
Martin-Luther Universität Halle-Wittenberg Recruiting
Halle an der Saale, Germany
Contact: Anja Rahnefeld       anja@rahnefeld.net   
Contact: Michael Tchirikov, Professor Dr. med.       michael.tchirikov@uk-halle.de   
Sponsors and Collaborators
Michael Tchirikov MD, PhD
  More Information

Responsible Party: Michael Tchirikov MD, PhD, Professor Dr. med., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT03151915     History of Changes
Other Study ID Numbers: NeoTTTS-1
First Submitted: May 3, 2017
First Posted: May 12, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fetofetal Transfusion
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases