| - candidate number | 6656 |
| - NTR Number | NTR2078 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 26-okt-2009 |
| - Secondary IDs | |
| - Public Title | Preventing Preterm birth with Progesterone: Costs and effects of screening healthy women with a singleton pregnancy for a short cervical length. |
| - Scientific Title | Preventing Preterm birth with Progesterone: Costs and effects of screening healthy women with a singleton pregnancy for a short cervical length. |
| - ACRONYM | Triple P |
| - hypothesis | Progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery. |
| - Healt Condition(s) or Problem(s) studied | Preterm birth, Short cervical length, Progesterone |
| - 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 | 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-nov-2009 |
| - planned closingdate | 1-nov-2011 |
| - Target number of participants | 1920 |
| - Interventions | 200 mg progestesteron daily for 10-12 weeks. |
| - Primary outcome | 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 outcome | 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. |
| - Timepoints | 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. |
| - Trial web site | http://www.studies-obsgyn.nl/TripleP |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Prof. B.W.J. Mol |
| - CONTACT for SCIENTIFIC QUERIES | Prof. B.W.J. Mol |
| - Sponsor/Initiator | |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | 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. |
| - Main changes (audit trail) | |
| - RECORD | 26-okt-2009 - 5-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl