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fetal fibronectin

multi center clinical trial of correlation of fFN concentration in pregnant women with premature and term parturition in china

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-RCH-13003688
Enrollment
Unknown
Registered
2013-09-02
Start date
2013-09-26
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

premature birth

Interventions

Cohorts:NA

Sponsors

general hospital of armed police forces
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: The correlation between fFN and preterm delivery (Study 1)inclusion criteria: A or BA. 24-28 gestational weeks, preterm birth with risk factors include: 1. the previous history of premature delivery or late abortion; 2. Aged 18 to 40 years; 3. underweight: pre pregnancy BMI >=18; 4. multiple pregnancy; 5. polyhydramnios; 6. development malformation of reproductive system: (double uterus, double angle and septate uterus etc.); 7. myoma of uterus (>4cm); 8. cervical incompetence (including cervical conization LEEP or history); 9. no prenatal care, low socioeconomic status; 10. pregnant women stand for a long time, especially the weekly standing for more than 40H; 11. Pregnancy after assisted reproduction technique; 12. The risk of infection of sexually transmitted disease, reproductive tract, or combined with sexually transmitted diseases; 13. with somatic diseases and pregnancy complications (including: viral hepatitis, acute pyelonephritis, acute appendicitis, severe anemia, chronic nephritis, heart disease, pregnancy induced hypertension syndrome, etc.) (1) 22-35 gestational week with threatened preterm labor symptoms (uterine or vaginal bleeding, etc.); The correlation between fFN and delivery (Study 2) inclusion criteria: (2) or (3, 4). before 40 weeks pregnant women with induced labor indications, no contraindication; (4) after 40 weeks patients with induction of prolonged pregnancy.

Exclusion criteria

Exclusion criteria: The correlation between fFN and preterm delivery (Study 1) study exclusion criteria: 1. vaginal disinfection before sampling in 24 hours; 2. severe vaginal bleeding; 3. premature rupture of membranes; 4. pregnant women can not bear the vagina secretion sampling of posterior fornix; 5. not to continue pregnancy (such as: placental abruption, fetal distress, severe surgical complications etc.); 6. the cervix has been opened more than 3-4cm; 7. the other fFN detecting contraindications. FFN launched the correlation and delivery (Study 2) study exclusion criteria: 8. vaginal disinfection before sampling in 24 hours; 9. severe vaginal bleeding; 10. premature rupture of membranes; 11. pregnant women can not bear the vagina secretion sampling of posterior fornix; 12. placenta, placental abruption, fetal distress, not vaginal delivery; 13. the other fFN detecting contraindications.

Countries

China

Contacts

Public ContactXiaoli Yang

Beijing Hotgen Biotech Co., Ltd

yangxiaolitwins@163.com+86 13581963388

Outcome results

None listed

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