The Use of Cervical Length to Reduce Hospital Stay in Wom... | NCT00432250

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

NCT00432250

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Feb 7, 2007Estimated

Enrollment

150

Phase

Phase 4

Conditions

Labor, Premature
Cervical Length

Interventions

Cervical length ultrasound

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Feb 6, 2007

First Submission Date that Met QC Criteria

Feb 6, 2007

First Posted Date

Feb 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2007

Last Update Posted Date

Feb 7, 2007Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Cervical length ultrasound	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay
Gestational age at delivery

Secondary Outcomes

Measure	Description	Time Frame
Rate of hospital stay below 3 days
Interval admission-to-delivery < 7 days
Rate of preterm delivery before 37 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Montse Palacio	Hospital Clinic of Barcelona	Principal Investigator
Vicenç Cararach	Hospital Clínic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínic of Barcelona		Sabino de Arana 1	Barcelona	08028	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided