NCT00432250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
Last Updated

February 7, 2007

Status Verified

February 1, 2007

First QC Date

February 6, 2007

Last Update Submit

February 6, 2007

Conditions

Labor, PrematureCervical Length

Keywords

Preterm laborCervical ultrasonographyHospital stay

Outcome Measures

Primary Outcomes (2)

  • Length of hospital stay

  • Gestational age at delivery

Secondary Outcomes (4)

  • 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

Interventions

Cervical length ultrasoundPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fetal death or malformation
  • Signs of chorioamnionitis
  • Non-reassuring fetal test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic of Barcelona

Sabino de Arana 1, Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Montse Palacio

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Vicenç Cararach

    Hospital Clínic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 7, 2007

Study Start

January 1, 2002

Study Completion

April 1, 2005

Last Updated

February 7, 2007

Record last verified: 2007-02

Locations

ES(1)