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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| yes stitch (will receive a larger stitch from laparotomy) | Experimental | yes stitch for a larger stitch when receiving a laparotomy. |
|
| No stitch | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-Amniotic Suture Placement | Other | Trans-Amniotic Suture placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Latency from surgery to delivery | Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Richards | Contact | 513-636-2310 | kimberly.richards@cchmc.org | |
| Erin Watters | Contact | 513-803-7024 | erin.watters@cchmc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38889699 | Background | Forde B, Sepulveda Gonzalez G, Lim FY, Arroyo-Lemarroy T, Nava Geurrero EN, Lizarraga-Cepeda E, Habli M, McKinney D, Hoffman M, Peiro JL. Should We Stitch-Close the Fetoscopic Percutaneous Access? A Case-Series of Laparotomy to Trans-Amniotic Membrane Suturing for Intrauterine Port Placement in Fetoscopic Surgery for Twins. Fetal Diagn Ther. 2024;51(5):510-515. doi: 10.1159/000539894. Epub 2024 Jun 18. | |
| 28910784 |
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We are using the data for CCHMC only.
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| ID | Term |
|---|---|
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Background |
| Kabagambe SK, Jensen GW, Chen YJ, Vanover MA, Farmer DL. Fetal Surgery for Myelomeningocele: A Systematic Review and Meta-Analysis of Outcomes in Fetoscopic versus Open Repair. Fetal Diagn Ther. 2018;43(3):161-174. doi: 10.1159/000479505. Epub 2017 Sep 15. |
| D007232 |
| Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |