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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00432250
Other study ID # CLHSPTL
Secondary ID
Status Completed
Phase Phase 4
First received February 6, 2007
Last updated February 6, 2007
Start date January 2002
Est. completion date April 2005

Study information

Verified date February 2007
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Health Services Research


Intervention

Procedure:
Cervical length ultrasound


Locations

Country Name City State
Spain Hospital Clínic of Barcelona Sabino de Arana 1 Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay
Primary Gestational age at delivery
Secondary Rate of hospital stay below 3 days
Secondary Interval admission-to-delivery < 7 days
Secondary Rate of preterm delivery before 37 weeks
Secondary Rate of preterm delivery before 34 weeks
See also
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Withdrawn NCT01206998 - Vaginal Progesterone as a Treatment for Women Active Preterm Labor N/A
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Terminated NCT00116623 - Magnesium Sulfate Versus Indomethacin for Preterm Labor Phase 4
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