Rupture of Fetal MembranesNCT01847820
Clinical Evaluation of the AmniSure ROM Test
An observational study of Rupture of Fetal Membranes, run by QIAGEN Gaithersburg, Inc at 4 sites in United States.
Trial summary
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Rupture of Fetal Membranes
- What is being tested?
- AmniSure ROM test
- Type of treatment
- Medical device
- How many people
- 383 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to Jul 2016
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation.
Who may be able to join
- Subjects must be pregnant.
- Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
- Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
- Subjects providing informed consent.
Who cannot join
- Subjects who have placenta previa.
- Subjects who have heavy vaginal bleeding.
- Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of California San Francisco- Fresno
Fresno, California, 93701
Indiana University
Indianapolis, Indiana, 46202
Kansas University Medical Center Research Institute, Inc
Kansas City, Kansas, 66160
About this study
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.
Read the detailed description
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
- Conditions
- Rupture of Fetal Membranes
- Being tested
- AmniSure ROM test
- Keywords
- ROM, PROM, PPROM (preterm premature rupture of membranes)
- 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.
AmniSure ROM testDevice
Comparison of AmniSure ROM test to clinical diagnosis of ROM.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Individuals with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation that will receive the AmniSure ROM test. Receives: Device: AmniSure ROM test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes.
Measured: One time at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Rupture of Fetal MembranesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847820
- Sponsor's protocol ID
- C13-ROM-001
- Status last verified
- Jul 2016
- First submitted
- 1 May 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson JW, Daikoku NH, Niebyl JR, Johnson TR Jr, Khouzami VA, Witter FR. Premature rupture of the membranes and prolonged latency. Obstet Gynecol. 1981 May;57(5):547-56.
PubMed 7219903LEBHERZ TB, HELLMAN LP, MADDING R, ANCTIL A, ARJE SL. DOUBLE-BLIND STUDY OF PREMATURE RUPTURE OF THE MEMBRANES. A REPORT OF 1,896 CASES. Am J Obstet Gynecol. 1963 Sep 15;87:218-25. doi: 10.1016/0002-9378(63)90502-7. No abstract available.
PubMed 14077618Gunn GC, Mishell DR Jr, Morton DG. Premature rupture of the fetal membranes. A review. Am J Obstet Gynecol. 1970 Feb 1;106(3):469-83. doi: 10.1016/0002-9378(70)90378-9. No abstract available.
PubMed 4905833Sacks M, Baker TH. Spontaneous premature rupture of the membranes. A prospective study. Am J Obstet Gynecol. 1967 Apr 1;97(7):888-93. doi: 10.1016/0002-9378(67)90512-1. No abstract available.
PubMed 6021103Daikoku NH, Kaltreider DF, Khouzami VA, Spence M, Johnson JW. Premature rupture of membranes and spontaneous preterm labor: maternal endometritis risks. Obstet Gynecol. 1982 Jan;59(1):13-20.
PubMed 7078844Christensen KK, Christensen P, Ingemarsson I, Mardh PA, Nordenfelt E, Ripa T, Solum T, Svenningsen N. A study of complications in preterm deliveries after prolonged premature rupture of the membranes. Obstet Gynecol. 1976 Dec;48(6):670-7.
PubMed 825795Fayez JA, Hasan AA, Jonas HS, Miller GL. Management of premature rupture of the membranes. Obstet Gynecol. 1978 Jul;52(1):17-21.
PubMed 683624Alexander JM, Cox SM. Clinical course of premature rupture of the membranes. Semin Perinatol. 1996 Oct;20(5):369-74. doi: 10.1016/s0146-0005(96)80003-6.
PubMed 8912990Philipson E.H., et al, Am. J. Perinatology., 1994, 11, No 6, pp.416-420.
Lockwood CJ, Wein R, Chien D, Ghidini A, Alvarez M, Berkowitz RL. Fetal membrane rupture is associated with the presence of insulin-like growth factor-binding protein-1 in vaginal secretions. Am J Obstet Gynecol. 1994 Jul;171(1):146-50. doi: 10.1016/0002-9378(94)90461-8.
PubMed 7518190Fuks et al. N-Dia Amnisure Abstract.
ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19. doi: 10.1097/01.AOG.0000263888.69178.1f.
PubMed 17400872Nisell H, Hagskog K, Westgren M. Assessment of fetal fibronectin in cervical secretion in cases of equivocal rupture of the membranes at term. Acta Obstet Gynecol Scand. 1996 Feb;75(2):132-4. doi: 10.3109/00016349609033304.
PubMed 8604598Atterbury JL, Groome LJ, Hoff C. Methods used to diagnose premature rupture of membranes: a national survey of 812 obstetric nurses. Obstet Gynecol. 1998 Sep;92(3):384-9. doi: 10.1016/s0029-7844(98)00178-1.
PubMed 9721775de Haan HH, Offermans PM, Smits F, Schouten HJ, Peeters LL. Value of the fern test to confirm or reject the diagnosis of ruptured membranes is modest in nonlaboring women presenting with nonspecific vaginal fluid loss. Am J Perinatol. 1994 Jan;11(1):46-50. doi: 10.1055/s-2007-994535.
PubMed 8155212
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the AmniSure ROM Test
- ClinicalTrials.gov ID
- NCT01847820
- Acronym / sponsor ID
- C13-ROM-001
- Conditions
- Rupture of Fetal Membranes
- Keywords
- ROM, PROM, PPROM (preterm premature rupture of membranes)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 383 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 May 2013 (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.
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.
Detailed description
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | Device: AmniSure ROM testIndividuals with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation that will receive the AmniSure ROM test. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation.
Key inclusion criteria (4 listed)
- Subjects must be pregnant.
- Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
- Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
- Subjects providing informed consent.
Key exclusion criteria (3 listed)
- Subjects who have placenta previa.
- Subjects who have heavy vaginal bleeding.
- Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.
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 |
|---|---|---|
| AmniSure ROM testComparison of AmniSure ROM test to clinical diagnosis of ROM. | Device | Symptomatic |
Primary outcome
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
Time frame: One time at time of enrollment
The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Background: PubMed 7219903Johnson JW, Daikoku NH, Niebyl JR, Johnson TR Jr, Khouzami VA, Witter FR. Premature rupture of the membranes and prolonged latency. Obstet Gynecol. 1981 May;57(5):547-56.
- Background: PubMed 14077618LEBHERZ TB, HELLMAN LP, MADDING R, ANCTIL A, ARJE SL. DOUBLE-BLIND STUDY OF PREMATURE RUPTURE OF THE MEMBRANES. A REPORT OF 1,896 CASES. Am J Obstet Gynecol. 1963 Sep 15;87:218-25. doi: 10.1016/0002-9378(63)90502-7. No abstract available.
- Background: PubMed 4905833Gunn GC, Mishell DR Jr, Morton DG. Premature rupture of the fetal membranes. A review. Am J Obstet Gynecol. 1970 Feb 1;106(3):469-83. doi: 10.1016/0002-9378(70)90378-9. No abstract available.
- Background: PubMed 6021103Sacks M, Baker TH. Spontaneous premature rupture of the membranes. A prospective study. Am J Obstet Gynecol. 1967 Apr 1;97(7):888-93. doi: 10.1016/0002-9378(67)90512-1. No abstract available.
- Background: PubMed 7078844Daikoku NH, Kaltreider DF, Khouzami VA, Spence M, Johnson JW. Premature rupture of membranes and spontaneous preterm labor: maternal endometritis risks. Obstet Gynecol. 1982 Jan;59(1):13-20.
- Background: PubMed 825795Christensen KK, Christensen P, Ingemarsson I, Mardh PA, Nordenfelt E, Ripa T, Solum T, Svenningsen N. A study of complications in preterm deliveries after prolonged premature rupture of the membranes. Obstet Gynecol. 1976 Dec;48(6):670-7.
- Background: PubMed 683624Fayez JA, Hasan AA, Jonas HS, Miller GL. Management of premature rupture of the membranes. Obstet Gynecol. 1978 Jul;52(1):17-21.
- Background: PubMed 8912990Alexander JM, Cox SM. Clinical course of premature rupture of the membranes. Semin Perinatol. 1996 Oct;20(5):369-74. doi: 10.1016/s0146-0005(96)80003-6.
- BackgroundPhilipson E.H., et al, Am. J. Perinatology., 1994, 11, No 6, pp.416-420.
- Background: PubMed 7518190Lockwood CJ, Wein R, Chien D, Ghidini A, Alvarez M, Berkowitz RL. Fetal membrane rupture is associated with the presence of insulin-like growth factor-binding protein-1 in vaginal secretions. Am J Obstet Gynecol. 1994 Jul;171(1):146-50. doi: 10.1016/0002-9378(94)90461-8.
- BackgroundFuks et al. N-Dia Amnisure Abstract.
- Background: PubMed 17400872ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19. doi: 10.1097/01.AOG.0000263888.69178.1f.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture of Fetal Membranes, run by QIAGEN Gaithersburg, Inc at 4 sites 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early. Results are not available in the source record.
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?
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes. (time frame: One time at time of enrollment). 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 NCT01847820, which also lists 32 linked publications.
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 14 Jul 2016.