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
|Condition or disease|
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|
|Actual Enrollment :||100 participants|
|Official Title:||Neonatales Outcome Nach Intrauteriner Laserablation Mit 1.0mm-Optik Bei Fetofetalem Transfusionssyndrom|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 31, 2017|
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.
- 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
- 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 ]
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
|Martin-Luther Universität Halle-Wittenberg|