The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Length of hospital stay
Gestational age at delivery
Secondary Outcomes
- 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