Premature BirthPhase 3NCT01442207
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
A Phase 3 study testing Placement of a Cervical Cerclage and Standard Expectant Management in people with Premature Birth and Placenta Previa, run by Obstetrix Medical Group.
Trial summary
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy. 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
- Premature Birth, Placenta Previa
- What is being tested?
- Placement of a Cervical Cerclage and Standard Expectant Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Singleton pregnancy, ≥ 18yrs old
- GA 18w0d to 26w0d inclusive @ time of enrollment
- Documentation of complete placenta previa (≥ 10mm over internal os)
- Agrees to participate in trial and signs/date an informed consent form.
Who cannot join
- Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
- Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
- Known uterine anomaly at time of enrollment
- History of two or more prior cesarean deliveries
- Suspected placenta accrete, increta or percreta on US at enrollment
- Cervical cerclage present at time of enrollment
About this study
Official title: Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.
Read the detailed description
The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.
- Conditions
- Premature Birth, Placenta Previa
- Being tested
- Placement of a Cervical Cerclage, Standard Expectant Management
- Keywords
- Premature Birth, Placenta Previa
- Medical subject headings
- Premature Birth, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a Cervical CerclageProcedure or surgery
Also called cerclage
Surgical placement of a cervical cerclage
Standard Expectant ManagementProcedure or surgery
Also called Expectant Management
Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes:
- Standard management for placenta previa.
- Hospital admission for vaginal bleeding/hemorrhage
- Antenatal corticosteroids > 24w0d of gestation
- Tocolytic therapy per physician's discretion
- Magnesium sulfate for neuroprotection
- Fetal Heart Rate Monitoring
- Avoidance of digital examinations of the cervix
- Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, PROM > 34 wks, worsening maternal or fetal condition )
- Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Placement of Cervical Cerclage | Active comparator | Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group Receives: Procedure: Placement of a Cervical Cerclage |
| Expectant Management | Placebo comparator | Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes:
* Standard management for placenta previa.
* Hospital admission for vaginal bleeding/hemorrhage
* Antenatal corticosteroids > 24w0d of gestation
* Tocolytic therapy per physician's discretion
* Magnesium sulfate for neuroprotection
* Fetal Heart Rate Monitoring
* Avoidance of digital examinations of the cervix
* Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, Premature rupture of the membranes (PROM) > 34 wks, worsening maternal or fetal condition )
* Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound. Receives: Procedure: Standard Expectant Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age (GA) at birth
The gestational age (GA) of the baby noted at birth
Measured: measure taken in the first 23 hours after birth.
Secondary outcomes (3)
Newborn Birth weight
Newborn Birth weight measure within 1-2 days after birth.
Measured: measured within 1-2 days after birth
Need for Maternal Blood Product replacement
Maternal need for blood product replacement such as Fresh Frozen Plasma.
Measured: measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)
Number of participants delivering prematurely following hemorrhage who have a positive fFN test.
Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.
Measured: measured at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Lack of randomized participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irene Stafford, MD, Principal investigator, Obstetrix Medical Group of Tucson.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442207
- Sponsor's protocol ID
- OBX 0018
- Status last verified
- Dec 2014
- First submitted
- 15 Sep 2011
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01442207
- Acronym / sponsor ID
- OBX 0018
- Conditions
- Premature Birth, Placenta Previa
- Keywords
- Premature Birth, Placenta Previa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of randomized participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Sep 2011 (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.
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.
Detailed description
The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placement of Cervical Cerclage | Active comparator | Procedure: Placement of a Cervical CerclageCervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group |
| Expectant Management | Placebo comparator | Procedure: Standard Expectant ManagementParticipants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes: * Standard management for placenta previa. * Hospital admission for vaginal bleeding/hemorrhage * Antenatal corticosteroids > 24w0d of gestation * Tocolytic therapy per physician's discretion * Magnesium sulfate for neuroprotection * Fetal Heart Rate Monitoring * Avoidance of digital examinations of the cervix * Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, Premature rupture of the membranes (PROM) > 34 wks, worsening maternal or fetal condition ) * Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancy, ≥ 18yrs old
- GA 18w0d to 26w0d inclusive @ time of enrollment
- Documentation of complete placenta previa (≥ 10mm over internal os)
- Agrees to participate in trial and signs/date an informed consent form.
Key exclusion criteria (6 listed)
- Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
- Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
- Known uterine anomaly at time of enrollment
- History of two or more prior cesarean deliveries
- Suspected placenta accrete, increta or percreta on US at enrollment
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 |
|---|---|---|
| Placement of a Cervical CerclageAlso: cerclageSurgical placement of a cervical cerclage | Procedure or surgery | Placement of Cervical Cerclage |
| Standard Expectant ManagementAlso: Expectant ManagementParticipants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes: * Standard management for placenta previa. * Hospital admission for vaginal bleeding/hemorrhage * Antenatal corticosteroids > 24w0d of gestation * Tocolytic therapy per physician's discretion * Magnesium sulfate for neuroprotection * Fetal Heart Rate Monitoring * Avoidance of digital examinations of the cervix * Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, PROM > 34 wks, worsening maternal or fetal condition ) * Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound. | Procedure or surgery | Expectant Management |
Primary outcome
Gestational age (GA) at birth
Time frame: measure taken in the first 23 hours after birth.
The gestational age (GA) of the baby noted at birth
3 secondary outcomes
Newborn Birth weight
Time frame: measured within 1-2 days after birth
Need for Maternal Blood Product replacement
Time frame: measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)
Number of participants delivering prematurely following hemorrhage who have a positive fFN test.
Time frame: measured at delivery
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 19 Dec 2014.
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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.
Irene Stafford, MD principal investigator
Obstetrix Medical Group of Tucson.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Placement of a Cervical Cerclage and Standard Expectant Management in people with Premature Birth and Placenta Previa, run by Obstetrix Medical Group.
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 6 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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gestational age (GA) at birth (time frame: measure taken in the first 23 hours after birth.). 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 19 Dec 2014.