Cerclage for Prevention on Preterm Birth in Women With Placenta Previa - Full Text View

Purpose

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.

Condition	Intervention	Phase
Premature Birth Placenta Previa	Procedure: Placement of a Cervical Cerclage Procedure: Standard Expectant Management	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	0
Study Start Date:	March 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Procedure: Placement of a Cervical Cerclage Surgical placement of a cervical cerclage Other Name: 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.	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

Arms

Assigned Interventions

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

Procedure: Placement of a Cervical Cerclage

Surgical placement of a cervical cerclage

Other Name: 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.

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442207

Sponsors and Collaborators

Obstetrix Medical Group

Investigators

Principal Investigator:

Irene Stafford, MD

Obstetrix Medical Group of Tucson.

More Information

No publications provided

Responsible Party:	Obstetrix Medical Group
ClinicalTrials.gov Identifier:	NCT01442207 History of Changes
Other Study ID Numbers:	OBX 0018
Study First Received:	September 15, 2011
Last Updated:	May 16, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:

Premature Birth
Placenta Previa

Additional relevant MeSH terms:

Placenta Previa
Premature Birth
Obstetric Labor Complications

Pregnancy Complications
Placenta Diseases
Obstetric Labor, Premature

ClinicalTrials.gov processed this record on May 22, 2013