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

NCT ID: NCT00432250

Last Updated: 2007-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Labor, Premature Cervical Length

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Interventions

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Cervical length ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Principal Investigators

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Montse Palacio

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Vicenç Cararach

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic of Barcelona

Locations

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Hospital Clínic of Barcelona

Sabino de Arana 1, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CLHSPTL

Identifier Type: -

Identifier Source: org_study_id

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