- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442207
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
December 17, 2014 updated by: Obstetrix Medical Group
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Placement of Cervical Cerclage
Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group
|
Surgical placement of a cervical cerclage
Other Names:
|
Placebo Comparator: Expectant Management
Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes:
|
Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
measure taken in the first 23 hours after birth.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Newborn Birth weight
Time Frame: measured within 1-2 days after birth
|
Newborn Birth weight measure within 1-2 days after birth.
|
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)
|
Maternal need for blood product replacement such as Fresh Frozen Plasma.
|
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
|
Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.
|
measured at delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Irene Stafford, MD, Obstetrix Medical Group of Tucson.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 15, 2011
First Submitted That Met QC Criteria
September 26, 2011
First Posted (Estimate)
September 28, 2011
Study Record Updates
Last Update Posted (Estimate)
December 19, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBX 0018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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