Preterm birth with healthy singleton pregnancies MedDRA version: 9.1 Level: LLT Classification code 10036600 Term: Premature labour
Conditions
Sponsors
AMC Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -- Capacitated women -- = 18 years old -- Singleton healthy pregnancy -- Two times a cervical length = 25 mm: a cervical length = 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: To evaluate whether the use of progesterone in women with a short cervical length can reduce the preterm delivery rate in these women. In addition, we evaluate whether a screening program with cervical length measurement and subsequent progesterone treatment is cost-effective. Primary outcome is composite bad neonatal condition (death or severe morbidity). This composite morbidity rate contains the following variables: -- severe Respiratory Distress Syndrome (RDS), -- Bronchopulmonary Dysplasia (BPD), -- Intraventricular Haemorrhage grade II B or worse, -- Necrotizing Enterocolitis (NEC), -- proven sepsis and death before discharge from the nursery These will be measured until 10 weeks after the expected term date. ;Secondary Objective: Secondary outcomes are delivery < 34 weeks, time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and 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. In addition, the study design will enable us to compare the costs and effects of the following strategies: I. no screening for cervical length II. screening for cervical length, treatment of women with a short cervical length, and deciding the cut-off levels for the cervical length ;Primary end point(s): A composite bad neonatal condition (death or severe morbidity) at 10 weeks corrected age. This composite morbidity rate contains the following variables: -- severe Respiratory Distress Syndrome (RDS), -- Bronchopulmonary Dysplasia (BPD), -- Intraventricular Haemorrhage grade II B or worse, -- Necrotizing Enterocolitis (NEC), -- proven sepsis and death before discharge from the nursery | — |
Countries
Netherlands
Outcome results
None listed