Fetal Membranes, Premature RuptureNCT01063686
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
A study testing insemination cervical cap in people with Fetal Membranes, Premature Rupture and Ultrasonography, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Ultrasonography
- What is being tested?
- insemination cervical cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
Who may be able to join
- Gestational age 14-23
- Single fetus
- Suspected rupture of membranes
- Oligohydramnios
Who cannot join
- Vaginal bleeding
- Suspected chorioamnionitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.
- Being tested
- insemination cervical cap
- Keywords
- Pregnancy
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insemination cervical capDevice
Also called CERVICAL CUP pre-cut standard size, C.C.D. International., Ref. 12050IS, 48, rue des Petites Ecuries, 75010 Paris
Primary abdominal ultrasound (US) for amniotic fluid index (AFI), Single vertical pocket, and dimensions of pocket below the presenting part. Speculum vaginal examination. In a sterile manner a cervical cap is adjusted on the cervix. the patient is kept recumbent for 6 hours. A repeat US exam is performed. The cervical cap is removed. After one hour another US is performed.
| Study group | Role | What they receive |
|---|---|---|
| Insemination cervical cap | No intervention | Not described Receives: Device: insemination cervical cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/
Measured: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement
Secondary outcomes (1)
chorioamnionitis and abortion
Measured: one week from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
Why it stopped: Insufficient Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Membranes, Premature RuptureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, david danon, Rabin Medical Center
- Investigators
- David Danon, MD, Principal investigator, Department of Ob/Gyn Rabin Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063686
- Sponsor's protocol ID
- rmc-0191
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2010
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
- ClinicalTrials.gov ID
- NCT01063686
- Acronym / sponsor ID
- rmc-0191
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- First posted
- 5 Feb 2010 (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.
Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insemination cervical cap | No intervention | Device: insemination cervical cap |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age 14-23
- Single fetus
- Suspected rupture of membranes
- Oligohydramnios
Key exclusion criteria (2 listed)
- Vaginal bleeding
- Suspected chorioamnionitis
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 |
|---|---|---|
| insemination cervical capAlso: CERVICAL CUP pre-cut standard size, C.C.D. International., Ref. 12050IS, 48, rue des Petites Ecuries, 75010 ParisPrimary abdominal ultrasound (US) for amniotic fluid index (AFI), Single vertical pocket, and dimensions of pocket below the presenting part. Speculum vaginal examination. In a sterile manner a cervical cap is adjusted on the cervix. the patient is kept recumbent for 6 hours. A repeat US exam is performed. The cervical cap is removed. After one hour another US is performed. | Device | Insemination cervical cap |
Primary outcome
Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/
Time frame: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement
1 secondary outcome
chorioamnionitis and abortion
Time frame: one week from the start of the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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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.
David Danon, MD principal investigator
Department of Ob/Gyn Rabin Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insemination cervical cap in people with Fetal Membranes, Premature Rupture and Ultrasonography, run by Rabin Medical Center at 1 site in Israel.
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 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: withdrawn, as of the sponsor's last update on 28 Oct 2015. 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 Israel. 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 withdrawn before enrolling participants, so there are no results.
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?
Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/ (time frame: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement). 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 28 Oct 2015.