Preventing Preterm birth with Progesterone: Costs and effects of screening healthy women with a singleton pregnancy for a short cervical length.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20454

Enrollment

1920

Registered

2009-10-26

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

preterm birth, short cervical length, progesterone, vroeggeboorte, cervixlengte, progesteron.

Interventions

200 mg progestesteron daily for 10-12 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Capacitated women; 2. 18 years or older; 3. Singleton healthy pregnancy; 4. Two times a cervical length shorter than 25 mm: a cervical length shorter than 25 mm at 16-20 weeks gestation and a confirmation of this result with a repeat measurement of the cervical length at 20-22 weeks gestation.

Exclusion criteria

Exclusion criteria: Women with a pregnancy with major foetal abnormalities, painful regular uterine contractions, a history of ruptured membranes or a cervical cerclage will be excluded. In addition, women with a previous preterm birth are excluded as well.

Design outcomes

Primary

Measure	Time frame
Primary outcome is composite bad neonatal condition (death or severe morbidity). This composite morbidity rate contains the following variables: 1. Severe Respiratory Distress Syndrome (RDS); 2. Bronchopulmonary Dysplasia (BPD); 3. Intraventricular Haemorrhage grade II B or worse; 4. Necrotizing Enterocolitis (NEC); 5. 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 is composite bad neonatal condition (death or severe morbidity). This composite morbidity rate contains the following variables: 1. Severe Respiratory Distress Syndrome (RDS); 2. Bronchopulmonary Dysplasia (BPD); 3. Intraventricular Haemorrhage grade II B or worse; 4. Necrotizing Enterocolitis (NEC); 5. 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 are: 1. Delivery < 34 weeks; 2. Time to delivery; 3. Preterm birth rate before 32 and 37 weeks; 4. Days of admission in neonatal intensive care unit; 5. Maternal morbidity; 6. Maternal admission days for preterm labour; 7. Costs. Moreover, we will look at growth, physical condition including close examination of the genital tract, and neurodevelopmental outcome of the offspring at 24 months (corrected) age.	—

Measure

Time frame

Secondary outcomes are: 1. Delivery < 34 weeks; 2. Time to delivery; 3. Preterm birth rate before 32 and 37 weeks; 4. Days of admission in neonatal intensive care unit; 5. Maternal morbidity; 6. Maternal admission days for preterm labour; 7. Costs. Moreover, we will look at growth, physical condition including close examination of the genital tract, and neurodevelopmental outcome of the offspring at 24 months (corrected) age.

—

Contacts

Public ContactB.W.J. Mol

Academic Medical Centre Dept Obstetrics and Gynaecology Room H4-213 PO Box 22700

b.w.mol@amc.nl+31 (0)20 5663919

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)