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

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ClinicalTrials.gov Identifier: NCT00432250
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : February 7, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Labor, Premature Cervical Length Procedure: Cervical length ultrasound Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Health Services Research
Study Start Date : January 2002
Estimated Study Completion Date : April 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay
  2. Gestational age at delivery

Secondary Outcome Measures :
  1. Rate of hospital stay below 3 days
  2. Interval admission-to-delivery < 7 days
  3. Rate of preterm delivery before 37 weeks
  4. Rate of preterm delivery before 34 weeks

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432250


Locations
Spain
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

ClinicalTrials.gov Identifier: NCT00432250     History of Changes
Other Study ID Numbers: CLHSPTL
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007

Keywords provided by Hospital Clinic of Barcelona:
Preterm labor
Cervical ultrasonography
Hospital stay

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications