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

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00432250

Purpose

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.

Condition	Intervention	Phase
Labor, Premature Cervical Length	Procedure: Cervical length ultrasound	Phase IV

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind, Active Control, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

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

Estimated Enrollment:	150
Study Start Date:	January 2002
Estimated Study Completion Date:	April 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432250

Locations

Spain, Barcelona
Hospital Clínic of Barcelona
Sabino de Arana 1, Barcelona, Spain, 08028

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:	Montse Palacio	Hospital Clinic of Barcelona
Principal Investigator:	Vicenç Cararach	Hospital Clínic of Barcelona

More Information

No publications provided

Study ID Numbers:	CLHSPTL
Study First Received:	February 6, 2007
Last Updated:	February 6, 2007
ClinicalTrials.gov Identifier:	NCT00432250 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Hospital Clinic of Barcelona:

Preterm labor
Cervical ultrasonography
Hospital stay

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on September 02, 2009