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

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length. - Quadruple P study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50366

Enrollment

960

Registered

2013-11-19

Start date

2014-07-29

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

preterm birth

Interventions

Daily progesterone 200mg will be self-administered vaginally from 18 weeks onwards. The silicone cervical pessary will be placed between 16-22 weeks (multiples) or 18-22 (singletons). Both intervent

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)