Will a cervical pessary prolong pregnancy in women who have been discharged after an episode of threatened preterm labor: a multicenter randomised clinical trial

Phase 3

Completed

• Conditions: preterm birth; preterm labour; 10028920

• Registration Number: NL-OMON45116
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Singleton or twin pregnancy
Gestational age between 24 0/7 and 34 6/7 weeks
Undelivered 48 hours after admission for preterm labor
At admission a Cervical length <15mm, or
Cervical length ><=15mm- <30mm and a positive fibronectin test or positive ACTIM-partus test

Exclusion Criteria

Major fetal abnormalities
Ruptured membranes
Signs of intra-uterine infection
Signs of fetal distress
Cervical dilatation * 3 cm
Residual cervical length that makes it impossible to place a pessary
>72 hours past after becoming eligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is preterm delivery before 37 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be neonatal morbidity and mortality, time to delivery,<br /><br>gestational age at delivery and re-admittance for new symptoms of preterm<br /><br>labour.</p><br>