Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

This study has been withdrawn prior to enrollment.
(Lack of randomized participants)
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT01442207
First received: September 15, 2011
Last updated: May 16, 2013
Last verified: May 2013

September 15, 2011
May 16, 2013
March 2012
May 2013   (final data collection date for primary outcome measure)
Gestational age (GA) at birth [ Time Frame: measure taken in the first 23 hours after birth. ] [ Designated as safety issue: Yes ]
The gestational age (GA) of the baby noted at birth
Gestational age (GA) at birth [ Time Frame: within 23 hours after birth ] [ Designated as safety issue: Yes ]
The gestational age (GA) of the baby noted at birth
Complete list of historical versions of study NCT01442207 on ClinicalTrials.gov Archive Site
  • Newborn Birth weight [ Time Frame: measured within 1-2 days after birth ] [ Designated as safety issue: Yes ]
    Newborn Birth weight measure 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) ] [ Designated as safety issue: Yes ]
    Maternal need for blood product replacement such as Fresh Frozen Plasma.
  • Number of participants delivering prematurely following hemorrhage who have a positive fFN test. [ Time Frame: measured at delivery ] [ Designated as safety issue: No ]
    Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.
  • Newborn Birth weight [ Time Frame: measured within 1-2 days after birth ] [ Designated as safety issue: Yes ]
    Newborn Birth weight measure immediately following birth.
  • Maternal need for Blood Product replacement [ Time Frame: measured from the time participant is enrollment in the study until she is discharge from hospital following birth. (up to approximately 40 weeks) ] [ Designated as safety issue: Yes ]
    Maternal need for blood product replacement such as Fresh Frozen Plasma.
  • Number of patients with a positive fetal fibronectin (fFN) who subsequently delivery prematurely as a result of hemorrhage with placenta previa. [ Time Frame: measured during the pregnancy ( an expected average of approximately 22 weeks) ] [ Designated as safety issue: No ]
    To date, fetal fibronectin (fFN) has not been studied in its ability to detect or predict premature delivery related to hemorrhage with placenta previa. As a secondary part of this study we propose determining whether this marker (fFN) of preterm delivery may be useful in pregnancies with placenta previas. From a strictly observational standpoint we will looks at the relationship between fFN markers and hemorrhage or preterm delivery.
Not Provided
Not Provided
 
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Premature Birth
  • Placenta Previa
  • Procedure: Placement of a Cervical Cerclage
    Surgical placement of a cervical cerclage
    Other Name: cerclage
  • Procedure: Standard 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.
    Other Name: Expectant Management
  • 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
    Intervention: Procedure: Placement of a Cervical Cerclage
  • Placebo Comparator: 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, Premature rupture of the membranes (PROM) > 34 wks, worsening maternal or fetal condition )
    • Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.
    Intervention: Procedure: Standard Expectant Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01442207
OBX 0018
Yes
Obstetrix Medical Group
Obstetrix Medical Group
Not Provided
Principal Investigator: Irene Stafford, MD Obstetrix Medical Group of Tucson.
Obstetrix Medical Group
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP