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Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Primary Purpose

Premature Birth, Placenta Previa

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Placement of a Cervical Cerclage

Standard Expectant Management

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Premature Birth, Placenta Previa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Placement of Cervical Cerclage

Expectant Management

Arm Description

Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group

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.

Outcomes

Primary Outcome Measures

Gestational age (GA) at birth

The gestational age (GA) of the baby noted at birth

Secondary Outcome Measures

Newborn Birth weight

Newborn Birth weight measure within 1-2 days after birth.

Need for Maternal Blood Product replacement

Maternal need for blood product replacement such as Fresh Frozen Plasma.

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.

Full Information

NCT ID

NCT01442207

First Posted

September 15, 2011

Last Updated

December 17, 2014

Sponsor

Obstetrix Medical Group

1. Study Identification

Unique Protocol Identification Number

NCT01442207

Brief Title

Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Official Title

Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of randomized participants

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Obstetrix Medical Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth, Placenta Previa

Keywords

Premature Birth, Placenta Previa

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placement of Cervical Cerclage

Arm Type

Active Comparator

Arm Description

Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group

Arm Title

Expectant Management

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Placement of a Cervical Cerclage

Other Intervention Name(s)

cerclage

Intervention Description

Surgical placement of a cervical cerclage

Intervention Type

Procedure

Intervention Name(s)

Standard Expectant Management

Other Intervention Name(s)

Expectant Management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Gestational age (GA) at birth

Description

The gestational age (GA) of the baby noted at birth

Time Frame

measure taken in the first 23 hours after birth.

Secondary Outcome Measure Information:

Title

Newborn Birth weight

Description

Newborn Birth weight measure within 1-2 days after birth.

Time Frame

measured within 1-2 days after birth

Title

Need for Maternal Blood Product replacement

Description

Maternal need for blood product replacement such as Fresh Frozen Plasma.

Time Frame

measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)

Title

Number of participants delivering prematurely following hemorrhage who have a positive fFN test.

Description

Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.

Time Frame

measured at delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irene Stafford, MD

Organizational Affiliation

Obstetrix Medical Group of Tucson.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

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