Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01442207
• Other study ID #: OBX 0018
• Status: Withdrawn
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: December 17, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2014
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Placenta Previa
• Premature Birth

Intervention

Procedure:
• Placement of a Cervical Cerclage
Surgical placement of a cervical cerclage
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age (GA) at birth	The gestational age (GA) of the baby noted at birth	measure taken in the first 23 hours after birth.	Yes
Secondary	Newborn Birth weight	Newborn Birth weight measure within 1-2 days after birth.	measured within 1-2 days after birth	Yes
Secondary	Need for Maternal Blood Product replacement	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)	Yes
Secondary	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.	measured at delivery	No