Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery

ConditionsTwin to Twin Transfusion Syndrome Twin Anemia-Polycythemia Sequence

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

This is a randomized trial for patients that are diagnosed with Twin-Twin Transfusion Syndrome (TTTS) who are receiving a fetoscopic laser surgery to evaluate the effectiveness and safety of a laparotomy closure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of TTTS or Twin Anemia-Polycythemia Sequence (TAPS)

Gestational age between 18 weeks and 23 weeks (18 0/7 to 22 6/7 weeks)

Cervical length >2.5 cm preoperatively

Identification of a safe percutaneous surgical window by a provider experienced in fetoscopic surgery prior to entering the operating room

Disqualifiers

Higher order pregnancies, chromosomal or severe congenital anomalies, undergoing laser surgery for fetal growth restriction only, need for a second laser during pregnancy, failure to complete laser, PPROM prior to surgery. BMI> 40 at the start of pregnancy, emergent case (i.e. surgery occurs < 6 hours from presentation), significant fetal anomalies expected to drastically alter the risk of neonatal morbidity or mortality (i.e. anencephaly, cyanotic heart disease), or any significant maternal comorbidities as determined by physician i.e.: clotting disorders/blood disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

Trans-Amniotic Suture Placement
Other intervention
Trans-Amniotic Suture placement

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: yes stitch (will receive a larger stitch from laparotomy)Experimental treatment 1 intervention

Group B: No stitchNo intervention 0 interventions

Trial outcomes

Primary outcomes

Latency from surgery to delivery

Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs.

Time frame

4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov

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