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

Brief Title

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

Official Title

Neonatales Outcome Nach Intrauteriner Laserablation Mit 1.0mm-Optik Bei Fetofetalem Transfusionssyndrom

Brief Summary

      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.
    

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.
    


Study Type

Observational


Primary Outcome

postoperative neonatal survival

Secondary Outcome

 Child's survival after fetoscopic laser coagulation

Condition

TTTS


Study Arms / Comparison Groups

 Patients who underwent fetoscopic laser coagulation with TTTS
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

January 1, 2017

Completion Date

December 31, 2017

Primary Completion Date

December 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of TTTS

          -  Ability to give informed consent in german or english

        Exclusion Criteria:

          -  Missing informed consent
      

Gender

Female

Ages

17 Years - 45 Years


Contacts

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Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03151915

Organization ID

NeoTTTS-1


Responsible Party

Sponsor-Investigator

Study Sponsor

Michael Tchirikov MD, PhD


Study Sponsor

, , 


Verification Date

January 2018