Multidisciplinary step in the prediction and primary prevention of preterm birth

Multidisciplinary step in the prediction and primary prevention of preterm birth - Prevention of Preterm Labour in Low Risk Women (PROPELLOR)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41673

Enrollment

4000

Registered

2013-08-30

Start date

2014-02-13

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

premature labour preterm birth

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Nulliparous women First visit in midwifery practice before a gestational age of 24 weeks Low risk pregnancy Maternal age > 18 years

Exclusion criteria

Exclusion criteria: Multiparous women First visit in midwifery practice and hospital beyond a gestational age of 24 weeks High risk pregnancy (indication for referral to 2nd or 3rd line) Multiple pregnancy Maternal age

Design outcomes

Primary

Measure	Time frame
Primary outcome is spontaneous preterm delivery before 37 weeks (expected incidence is approximately 5%)	—

Secondary

Measure	Time frame
Secondary outcome measures are: - preterm delivery before 28, 32 and 34 weeks - the number of women that present for signs and symptoms of preterm birth - referral to secondary/tertiary care for threatened preterm birth - administration of corticosteroids and tocolysis - maternal admission days for preterm labour and costs - time to delivery - maternal morbidity - perinatal mortality - perinatal morbidity (respiratory distress syndrome (RDS), broncho pulmonal dysplasia (BPD), intraventricular haemorrhage (IVH) grade 3 or worse, necrotizing enterocolitis (NEC) stage 2B or higher, periventricular leucomalacia (PVL), rethinopathy of prematurity (ROP), and culture proven sepsis) - days of admission in neonatal intensive care unit - financial costs - long term neonatal outcome (developmentscores)	—

Measure

Time frame

Secondary outcome measures are: - preterm delivery before 28, 32 and 34 weeks - the number of women that present for signs and symptoms of preterm birth - referral to secondary/tertiary care for threatened preterm birth - administration of corticosteroids and tocolysis - maternal admission days for preterm labour and costs - time to delivery - maternal morbidity - perinatal mortality - perinatal morbidity (respiratory distress syndrome (RDS), broncho pulmonal dysplasia (BPD), intraventricular haemorrhage (IVH) grade 3 or worse, necrotizing enterocolitis (NEC) stage 2B or higher, periventricular leucomalacia (PVL), rethinopathy of prematurity (ROP), and culture proven sepsis) - days of admission in neonatal intensive care unit - financial costs - long term neonatal outcome (developmentscores)

—

Countries

Netherlands

Outcome results