Pessary or Cerclage to prevent preterm delivery in women with short cervical length with and a history of preterm birth.

Phase 3

Recruiting

Conditions: preterm birth
preterm delivery
10028920

Registration Number: NL-OMON47528

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

1. Singleton pregnancy
2. History of preterm birth before 34 weeks of gestation
AND
3. Cervical length of 25mm or less on transvaginal ultrasound before 24 weeks
of GA
OR
Indication for primary cerclage before 16 weeks in current pregnancy based on
obstetric history, according to local protocol

Exclusion Criteria

-placenta previa
-vasa previa
-age less than 18 years
-inability to give informed consent
-identified major congenital abnormalities
-Premature Prelabour Rupture of the Membranes (PPROM)
-Cervical dilatation 3cm or more
-Signs of infection or fetal distress

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- delivery before 32 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- delivery before 24 weeks<br /><br>- delivery before 28 weeks<br /><br>- delivery before 34 weeks<br /><br>- delivery before 37 weeks<br /><br>- time from intervention to delivery<br /><br>- (early) premature rupture of membranes<br /><br>- maternal infection<br /><br>- maternal side effects, i.e. vaginal discharge, bleeding, discomfort,<br /><br>dyspareunia<br /><br>- neonatal mortality; i.e. in-hospital death<br /><br>- neonatal morbidity</p><br>