An interventional study of Trans-Amniotic Suture Placement in Twin to Twin Transfusion Syndrome and Twin Anemia-Polycythemia Sequence, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
The rationale behind suturing the hole is that the amniotic membrane does not close itself, rather you are relying that the uterus closes over the hole in the amniotic membrane, which may or may not happen, as well as in fetoscopic surgery for another condition, myelomeningocele. Published data has shown that maternal laparotomy to suture closure of the port site at the time of fetoscopic surgery leads to improved pregnancy outcomes, later gestational age at delivery, and lower rates of preterm pre-labor rupture of membranes (PPROM) [PMID: 28910784].
31 studies on the registry are indexed under Fetofetal Transfusion; 13 are open to participants now.
This study's planned enrollment of 34 is below the median of 160 across 17 interventional studies indexed under Fetofetal Transfusion.
Browse Fetofetal Transfusion studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 134 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
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Exclusion Criteria:
yes stitch for a larger stitch when receiving a laparotomy.
Other: Trans-Amniotic Suture Placement
Trans-Amniotic Suture placement
Latency from surgery to delivery
Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs.
Time frame: 4 months
Plan to share: No — We are using the data for CCHMC only.
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Children's Hospital Medical Center, Cincinnati →