Preterm Premature Rupture of MembraneNCT04963465
The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
An observational study of Preterm Premature Rupture of Membrane and Amniotic Fluid Leakage, run by Albany Medical College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane, Amniotic Fluid Leakage
- What is being tested?
- Ferning on microscopy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Prospective observational study including pregnant women 18 years or older who present for pregnancy termination, between 15 and 24 weeks gestation. Women with a singleton or multi-fetal gestation, who have previously established dating based on a first trimester ultrasound or ultrasound prior to 22 weeks gestation, will be included. Exclusion criterion are women who are less than 18 years of age, non-English speaking, and rupture of membranes or anhydramnios (no measurable amniotic fluid on ultrasound) at the time of data collection in the operating room.
Who may be able to join
- 18 years or older
- English speaking
- singleton or multi fetal gestation
- between 15 and 24 weeks gestation
- undergoing elective pregnancy termination
Who cannot join
- known rupture of membranes or anhydramnios
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
OBGYN Research Director, 518-262-4942, Obgynresearch@amc.edu
About this study
Official title: Assessing the Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
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.
- Being tested
- Ferning on microscopy
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferning on microscopyDiagnostic test
Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes
| Study group | Role | What they receive |
|---|---|---|
| Before rupture of membranes | Vaginal swab collection prior to iatrogenic rupture of membranes Receives: Diagnostic Test: Ferning on microscopy | |
| After rupture of membranes | Vaginal swab collection after iatrogenic rupture of membranes Receives: Diagnostic Test: Ferning on microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferning
the presence of amniotic fluid ferning
Measured: 1 minute
Ferning
the presence of amniotic fluid ferning
Measured: 5 minutes
Ferning
the presence of amniotic fluid ferning
Measured: 10 minutes
Ferning
the presence of amniotic fluid ferning
Measured: 15 minutes
Ferning
the presence of amniotic fluid ferning
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start17 Sep 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OBGYN Research Director, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963465
- Sponsor's protocol ID
- 6229
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
- ClinicalTrials.gov ID
- NCT04963465
- Acronym / sponsor ID
- 6229
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before rupture of membranes | – | Diagnostic Test: Ferning on microscopyVaginal swab collection prior to iatrogenic rupture of membranes |
| After rupture of membranes | – | Diagnostic Test: Ferning on microscopyVaginal swab collection after iatrogenic rupture of membranes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective observational study including pregnant women 18 years or older who present for pregnancy termination, between 15 and 24 weeks gestation. Women with a singleton or multi-fetal gestation, who have previously established dating based on a first trimester ultrasound or ultrasound prior to 22 weeks gestation, will be included. Exclusion criterion are women who are less than 18 years of age, non-English speaking, and rupture of membranes or anhydramnios (no measurable amniotic fluid on ultrasound) at the time of data collection in the operating room.
Key inclusion criteria (5 listed)
- 18 years or older
- English speaking
- singleton or multi fetal gestation
- between 15 and 24 weeks gestation
- undergoing elective pregnancy termination
Key exclusion criteria (1 listed)
- known rupture of membranes or anhydramnios
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferning on microscopyAmniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes | Diagnostic test | After rupture of membranes, Before rupture of membranes |
Primary outcome
Ferning
Time frame: 1 minute
the presence of amniotic fluid ferning
Ferning
Time frame: 5 minutes
the presence of amniotic fluid ferning
Ferning
Time frame: 10 minutes
the presence of amniotic fluid ferning
Ferning
Time frame: 15 minutes
the presence of amniotic fluid ferning
Ferning
Time frame: 20 minutes
the presence of amniotic fluid ferning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OBGYN Research Director principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membrane and Amniotic Fluid Leakage, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OBGYN Research Director (518-262-4942, Obgynresearch@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferning (time frame: 1 minute). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.