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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00432250
First received: February 6, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Health Services Research

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 23, 2014