Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

NCT01442207 | Withdrawn Phase 3 DMC

• 1 other identifier: OBX 0018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Birth; Placenta Previa

Keywords

Premature Birth; Placenta Previa

Outcome Measures

Primary Outcomes (1)

• Gestational age (GA) at birth

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

  measure taken in the first 23 hours after birth.

Secondary Outcomes (3)

• Newborn Birth weight

  measured within 1-2 days after birth

• Need for Maternal Blood Product replacement

  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.

  measured at delivery

Study Arms (2)

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

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.

Procedure: Standard Expectant Management

Interventions

Placement of a Cervical Cerclage PROCEDURE

Surgical placement of a cervical cerclage

Also known as: cerclage

Placement of Cervical Cerclage

Standard Expectant Management PROCEDURE

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.

Also known as: Expectant Management

Expectant Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Obstetrix Medical Group: lead

MeSH Terms

Conditions

Premature Birth; Placenta Previa

Interventions

Cerclage, Cervical; Watchful Waiting

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Irene Stafford, MD

  Obstetrix Medical Group of Tucson.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 28, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 19, 2014

Record last verified: 2014-12