Progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery.
ID
Bron
Verkorte titel
Aandoening
preterm birth, short cervical length, progesterone, vroeggeboorte, cervixlengte, progesteron.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome is composite bad neonatal condition (death or severe morbidity). This composite morbidity rate contains the following variables:<br>
1. Severe Respiratory Distress Syndrome (RDS);<br>
2. Bronchopulmonary Dysplasia (BPD);<br>
3. Intraventricular Haemorrhage grade II B or worse;<br>
4. Necrotizing Enterocolitis (NEC);<br>
5. Proven sepsis and death before discharge from the nursery. <br>
They will be measured until 10 weeks after the expected term date.
Achtergrond van het onderzoek
Preventing Preterm birth with Progesterone: Costs and effects of screening healthy women with a singleton pregnancy for a short cervical length. To evaluate whether progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery. In addition to assess whether it is cost-effective to do so.
Doel van het onderzoek
Progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery.
Onderzoeksopzet
Initially we aim at 1920 women. To obtain this amount of women, we hypothesize that we have to screen 40.000 women. An independent DSMC will look at the data after inclusion of 10.000, 20.000 and 30.000 women for safety, effectiveness and futility. If available, the DSMC can take into account the results of trials running abroad. We will continue the study untill january 1st 2014 or untill recruitment is completed, whatever comes first.
Onderzoeksproduct en/of interventie
200 mg progestesteron daily for 10-12 weeks.
Publiek
Dept Obstetrics and Gynaecology<br>
Room H4-213<br>
PO Box 22700
B.W.J. Mol
Amsterdam 1105 DE
The Netherlands
+31 (0)20 5663919
b.w.mol@amc.nl
Wetenschappelijk
Dept Obstetrics and Gynaecology<br>
Room H4-213<br>
PO Box 22700
B.W.J. Mol
Amsterdam 1105 DE
The Netherlands
+31 (0)20 5663919
b.w.mol@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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