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

February 6, 2007 updated by: Hospital Clinic of Barcelona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabino de Arana 1, Barcelona, Spain, 08028
        • Hospital Clinic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of hospital stay
Gestational age at delivery

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Montse Palacio, Hospital Clinic of Barcelona
  • Principal Investigator: Vicenç Cararach, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 7, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2007

Last Update Submitted That Met QC Criteria

February 6, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLHSPTL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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