The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
Primary Purpose
Labor, Premature, Cervical Length
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Cervical length ultrasound
Sponsored by
About this trial
This is an interventional health services research trial for Labor, Premature focused on measuring Preterm labor, Cervical ultrasonography, Hospital stay
Eligibility Criteria
Inclusion Criteria:
- Admitted because of preterm labor
- Not delivered after 24-48 h of admission
- Single pregnancy
- Intact membranes
- Gestational age between 24.0 and less tahn 36.0 weeks
- Bishop score < 6
Exclusion Criteria:
- Fetal death or malformation
- Signs of chorioamnionitis
- Non-reassuring fetal test
Sites / Locations
- Hospital Clínic of Barcelona
Outcomes
Primary Outcome Measures
Length of hospital stay
Gestational age at delivery
Secondary Outcome Measures
Rate of hospital stay below 3 days
Interval admission-to-delivery < 7 days
Rate of preterm delivery before 37 weeks
Rate of preterm delivery before 34 weeks
Full Information
NCT ID
NCT00432250
First Posted
February 6, 2007
Last Updated
February 6, 2007
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00432250
Brief Title
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
5. Study Description
Brief Summary
The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.
Detailed Description
Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:
CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.
STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Premature, Cervical Length
Keywords
Preterm labor, Cervical ultrasonography, Hospital stay
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cervical length ultrasound
Primary Outcome Measure Information:
Title
Length of hospital stay
Title
Gestational age at delivery
Secondary Outcome Measure Information:
Title
Rate of hospital stay below 3 days
Title
Interval admission-to-delivery < 7 days
Title
Rate of preterm delivery before 37 weeks
Title
Rate of preterm delivery before 34 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Admitted because of preterm labor
Not delivered after 24-48 h of admission
Single pregnancy
Intact membranes
Gestational age between 24.0 and less tahn 36.0 weeks
Bishop score < 6
Exclusion Criteria:
Fetal death or malformation
Signs of chorioamnionitis
Non-reassuring fetal test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montse Palacio
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicenç Cararach
Organizational Affiliation
Hospital Clínic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic of Barcelona
City
Sabino de Arana 1
State/Province
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
We'll reach out to this number within 24 hrs