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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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 weigh
Sponsor: Michael Tchirikov MD, PhD

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Martin-Luther-Universität Halle-Wittenberg

Dates:
Date Received: May 3, 2017
Date Started: January 1, 2017
Date Completion: December 1, 2017
Last Updated: May 12, 2017
Last Verified: May 2017