Evidence of Ruptured Membranes in Women Greater Than 15 WeekdNCT02208011
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
An observational study of Evidence of Ruptured Membranes in Women Greater Than 15 Weekd, run by Louisiana State University, Baton Rouge at 1 site in United States.
Trial summary
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Evidence of Ruptured Membranes in Women Greater Than 15 Weekd
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.
Who may be able to join
- complaint of ruptured membranes
- IUP > 15 weeks gestation
- English speaking, over the age of 18yrs old
Who cannot join
- active bleeding
- placenta previa
Trial locations and contacts
1 site in 1 country.
About this study
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.
Inclusion Criteria:
- English speaking
- pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes
Exclusion Criteria:
- Known placental previa
- Active vaginal bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of ruptured membranes
Measured: up to delivery of infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evidence of Ruptured Membranes in Women Greater Than 15 WeekdStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University, Baton Rouge
- Sponsor type
- University, hospital or other
- Collaborators
- Woman's Hospital, Louisiana, Clinical Innovations, LLC, Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Iro Igbinosa, Louisiana State University, Baton Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208011
- Sponsor's protocol ID
- L8608-W13010
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
Publications
Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y.
PubMed 28446135
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
- ClinicalTrials.gov ID
- NCT02208011
- Acronym / sponsor ID
- L8608-W13010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Louisiana State University, Baton RougeUniversity, hospital or other
- Collaborators
- Woman's Hospital, Louisiana, Clinical Innovations, LLC, Louisiana State University Health Sciences Center in New Orleans
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- 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.
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.
Inclusion Criteria:
- English speaking
- pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes
Exclusion Criteria:
- Known placental previa
- Active vaginal bleeding
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.
Key inclusion criteria (3 listed)
- complaint of ruptured membranes
- IUP > 15 weeks gestation
- English speaking, over the age of 18yrs old
Key exclusion criteria (2 listed)
- active bleeding
- placenta previa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evidence of ruptured membranes
Time frame: up to delivery of infant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 28446135Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Evidence of Ruptured Membranes in Women Greater Than 15 Weekd, run by Louisiana State University, Baton Rouge 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of ruptured membranes (time frame: up to delivery of infant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208011, which also lists 1 linked publication.
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 2 Sep 2020.