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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151915
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date May 3, 2017
First Posted Date May 12, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date January 1, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All pregnant women with TTS
Condition TTTS
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2017)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing informed consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 17 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03151915
Other Study ID Numbers NeoTTTS-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor Michael Tchirikov MD, PhD
Collaborators Not Provided
Investigators Not Provided
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date January 2018