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NCT04963465
The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
trial testing Ferning on microscopy in Preterm Premature Rupture of Membrane in 100 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Albany Medical College |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 17 September 2021 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ferning on microscopy
Conditions studied
- Preterm Premature Rupture of Membrane — all drugs for Preterm Premature Rupture of Membrane →
- Amniotic Fluid Leakage — all drugs for Amniotic Fluid Leakage →
Sponsor
Albany Medical College
Who can join
18 and older, female only, with Preterm Premature Rupture of Membrane or Amniotic Fluid Leakage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04963465 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Albany Medical College
- Last refreshed: 18 April 2023
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