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Establishment and validation of a predictive model for second-trimester fetal lumbosacral closed spina bifida based on ultrasound imaging parameters

Establishment and validation of a predictive model for second-trimester fetal lumbosacral closed spina bifida based on ultrasound imaging parameters

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053544
Enrollment
Unknown
Registered
2021-11-24
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spina bifida

Interventions

Gold Standard:Autopsy after labor induction or MRI after birth confirmed closed spina bifida
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Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Part I Inclusion Criteria: (1) There is no age limit for pregnant women, and the gestational week is 22-28w; (2) A section of the spine facing the maternal abdominal wall can be obtained; (3) Satisfactory 3D reconstructed images can be obtained; (4) The case group requires prenatal ultrasound to be suspected of fetal sacrococcygeal closed spina bifida, or lumbosacral closed spina bifida confirmed by labor induction or other imaging studies (X-ray, MRI or CT) after birth, follow-up for 1 year after birth; (5) The control group randomly selected 80 cases of fetuses in the second trimester of the same period with no abnormal fetuses found in the fetal system screening, all of which were confirmed to be normal after delivery. 2. The second part of the inclusion criteria: (1) There is no age limit for pregnant women, and the gestational week is 22-28w; (2) A section of the spine facing the maternal abdominal wall can be obtained; (3) Satisfactory 3D reconstructed images can be obtained; (4) Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The first part of the exclusion criteria: (1) The clinical information of pregnant women is missing; (2) Combined with congenital diseases unrelated to CSB; (3) The quality of the imaging data of pregnant women could not meet the analysis standard. 2. The second part of the exclusion criteria: (1) The clinical information of pregnant women is missing; (2) Combined with congenital diseases unrelated to CSB; (3) The quality of the imaging data of pregnant women cannot meet the analysis standard; (4) Participate in other clinical researches.

Design outcomes

Primary

MeasureTime frame
Intervertebral space measurement;Cone position;Spine curvature;

Countries

China

Contacts

Public ContactZhang Weiping

The First Affiliated Hospital of Nanchang University

454887926@qq.com+86 18170828720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026