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

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Halle, Germany
    • Martin-Luther Universität Halle-Wittenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All pregnant women with TTS

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Missing informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative neonatal survival	rate of intrauterine demise until demission	48 hours after fetoscopic surgery
Gestational Age at delivery	average gestational Age at delivery	at delivery
Long term neonatal survival	rate of fetal demise until delivery	fetoscopic surgery until delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's survival after fetoscopic laser coagulation	at least one child survives; both children survive; intrauterine foetal death of both children	one minute after delivery
Premature rupture of membranes		48 hours after fetoscopic surgery
Reoccurrence of TTTS after the procedure		48 hours after fetoscopic surgery

Collaborators and Investigators

• Sponsor: Michael Tchirikov MD, PhD

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NeoTTTS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No