Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length.

Phase 3

Completed

Conditions: preterm birth
10028920

Registration Number: NL-OMON50366

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 960

Inclusion Criteria

Women with a singleton pregnancy between 18 and 22 weeks and a cervical length
less or equal to 35 mm. Or multiple pregnancy between 16 and 22 weeks GA and a
cervical length less than 38mm.

Exclusion Criteria

1. Cervical cerclage in this pregnancy
2. Maternal age less than 18 years
3. Identified major congenital abnormalities in this pregnancy
4. Death of one or both of the foetuses in this pregnancy
5. Spontaneous preterm birth < 34 weeks in previous pregnanciesy,
6. Participation Quadruple P study in previous pregnanciesy
7. Cervical length less then 2mm
8. Cervical dilatation of 3cm or more
9. blood loss or contractions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome will be a composite morbidity and mortality rate of children in<br /><br>the two groups. This composite morbidity rate contains the following variables:<br /><br>severe Respiratory Distress Syndrome (RDS), Broncho Pulmonal Dysplasia (BPD),<br /><br>Intraventricular Haemorrhage II B or worse, Necrotizing Enterocolitis (NEC),<br /><br>proven sepsis and death before discharge from the nursery. They will be<br /><br>measured until 10 weeks after the expected term date. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be time to delivery, preterm birth rate before 28, 32<br /><br>and 37 weeks, neonatal death, severe neonatal morbidity, days of admission in<br /><br>neonatal intensive care unit, maternal morbidity, maternal admission days for<br /><br>preterm labour and costs and longterm effects. Data on women with a normal<br /><br>cervical length will be obtained from the national perinatal registry. </p><br>