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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
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)Female

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

First Posted
February 6, 2007
Last Updated
February 6, 2007
Sponsor
Hospital Clinic of Barcelona
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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

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The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.

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