The Effect of Uterine Entry In Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetoscopic Laser Photocoagulation.
- Who it may be relevant to
- Registry conditions: Twin to Twin Transfusion. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Entry Technique on Chorioamniotic Membrane Separation in Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
Overview
The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation.
Detailed description
Patients who choose to undergo fetoscopic selective laser photocoagulation (SFLP) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and participants will be provided a copy of the signed consent.
After consent has been obtained, participants will be randomized into two groups ("direct entry" and "Seldinger technique").
Procedure: Selective laser photocoagulation (SFLP) is standard of care for the treatment of complicated monochorionic twin pregnancies. Entry into the uterus for SFLP is achieved under ultrasound guidance using one of two accepted methods, direct entry or the Seldinger technique. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure.
Group I - Direct entry: The surgeon will gain access to the uterus by inserting a sharp trocar through a small incision in the skin. After access has been established, the trocar is removed and a small tube called a cannula is left in place.
Group II - Seldinger technique: The surgeon will gain access to the uterus by inserting needle through a small incision in the skin and run a guide wire through the needle so a thin tube called a cannula can be placed over the wire.
Follow-Up:
Participants will be monitored after the procedure and upon discharge from the hospital they are free to resume care with their primary doctor. Investigators will collect follow-up data on the health of the participant and the babies until the babies turn one month old.
Interventions
- Procedure Fetoscopic Laser Photocoagulation
Patients who choose to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome will be offered participation in the study. All participants will undergo selective laser photocoagulation and entry into the uterus will be achieved using one of two accepted methods, either direct entry or the Seldinger technique.
Primary outcome measures
- Rate of Immediate Chorioamniotic Membrane Separation (CAS) [Time frame: Up to hospital discharge post-procedure (up to 5 days)]
Secondary outcome measures (8)
- Rate of Chorioamniotic Membrane Separation (CAS) [Time frame: From the post-surgical period (outside the first 24 hours) until delivery, up to 25 weeks]
- Gestational Age at Delivery [Time frame: At delivery]
- Preterm Birth [Time frame: At delivery]
- Procedure to Delivery Interval [Time frame: At delivery]
- Placental Abruption [Time frame: Up to hospital discharge post-procedure (up to 5 days)]
- Chorioamnionitis [Time frame: Up to hospital discharge post-procedure (up to 5 days)]
- Septostomy [Time frame: Up to hospital discharge post-procedure (up to 5 days)]
- Preterm Premature Rupture of Membranes (PPROM) [Time frame: At delivery]
Eligibility criteria
Inclusion criteria
- Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.
- Patients will be between 16 0/7 weeks and 26 0/7 weeks gestational age.
Exclusion criteria
- Patients who do not elect to undergo fetoscopic laser photocoagulation for the treatment of complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.
- Triplets and higher order multiple gestations.
- Patients who are less than 16 0/7 weeks or greater than 26 0/7 weeks gestational age.
- Patients with a short cervix (less than 1.5 cm).
- Patients with a known subchorionic hemorrhage.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Texas Children's Hospital - Pavilion for Women — Houston
Publications
- Burnett BA, Munoz JL, Johnson RM, Parobek CM, Delgadillo Chabolla LE, Buskmiller C, Donepudi RV, Sanz Cortes M, Belfort MA, Nassr AA. The effect of uterine entry technique on chorioamniotic membrane separation in fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome: protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Nov 21;25(1):1253. doi: 10.1186/s12884- PMID 41272584
Identifiers
NCT: NCT06829901 · H-56175