Microparticle orientated risk evaluation and prediction of pre-eclampsia among risk pregnancies
| ISRCTN | ISRCTN92923842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92923842 |
| Secondary identifying numbers | FI 1635/1-1 |
- Submission date
- 02/04/2009
- Registration date
- 28/07/2009
- Last edited
- 28/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Justine Sayuri Fitzgerald
Scientific
Scientific
Abteilung für Geburtshilfe der Universitätsfrauenklinik Jena
Bachstr. 18
Jena
07743
Germany
| Phone | +49 (0)3641 514 320 |
|---|---|
| fitzgerald@med.uni-jena.de |
Study information
| Study design | Multicentre prospective blinded phase I prognostic marker pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact fitzgerald@med.uni-jena.de or ekkehard.schleussner@med.uni-jena.de to request a patient information sheet |
| Scientific title | Microparticle Orientated Risk Evaluation and Prediction of Pre-eclampsia Among Risk gravidas: a multicentre prospective phase I prognostic marker study |
| Study acronym | MORE PrePARd |
| Study objectives | The objective is to elucidate whether serum microparticle concentrations of pregnant women with abnormal uterine perfusion (a high risk group), both measured at 20th week of gestation, can discriminate between women who will develop preeclampsia (case group) and those who will not (control group). |
| Ethics approval(s) | Local ethics committee (Ethik-Kommission der Universitätsklinikum Jena) approved on the 26th August 2008 (ref: 2370-08/08) |
| Health condition(s) or problem(s) studied | Pre-eclampsia/pregnancy |
| Intervention | Total of 80 - 100 pregnant women with abnormal uterine perfusion, including 20 women who develop pre-eclampsia during pregnancy (cases) and 60 - 80 woman who do not develop pre-eclampsia (controls). Patients with risk pregnancies for preeclampsia will be recruited for marker measurement between 19th and 21st week of gestation. Experimental test: Measurement of syncytiotophoblast microparticle (STBM) concentration in maternal serum at time of study inclusion. Reference test: Assessment of objective clinical symptoms of preeclampsia according to the German Society of Obstetrics and Gynecology (DGGG)-diagnostic criteria at 8-week intervals: 1. Hypertension defined as blood pressure (RR) systolic greater than or equal to 140 mmHg and/or diastolic greater than or equal to 90 mmHg, and 2. Proteinuria: Dipstick-Test greater than or equal to 1+ or greater than or equal to 300 mg total protein in 24-hour urine collection There are two optional visits between the 19th and 21st week of gestation and birth: first visit at 27th to 29th week of gestation and second visit at 35th to 37th week of gestation to monitor these risk pregnancies. Final outcome will be assessed at 6 weeks post-partum. |
| Intervention type | Other |
| Primary outcome measure | Development of pre-eclampsia during current pregnancy. Final outcome will be assessed 6 weeks post-partum either by study doctor or attending doctor. |
| Secondary outcome measures | Pre-eclampsia associated complications: 1. Differentiation early onset/severe and late onset/mild pre-eclampsia 2. Intra-uterine growth restriction (IUGR) or small for gestational age (SGA) 3. Induction of preterm labour/delivery 4. Intra-uterine foetal demise (IUFD) 5. Placental abruption Final outcome will be assessed 6 weeks post-partum either by study doctor or attending doctor. |
| Overall study start date | 20/04/2009 |
| Completion date | 20/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 -100 pregnant women |
| Key inclusion criteria | 1. Abnormal uterine artery Doppler ultrasound 2. Singleton pregnancy 3. Appropriate-for-gestational-age foetus 4. 19th - 21st week of gestation 5. Healthy, normotensive gravidas 6. Women, all ages considered normal-risk pregnancy: 18 - 40 years |
| Key exclusion criteria | 1. Concurrent participation in interventional clinical studies 2. Multiple pregnancy 3. Premature rupture of membrane (PROM) 4. Suspected/diagnosed infected amnion syndrome (IAS) 5. Pre-term labour/cervical incompetence 6. Foetal genopathia 7. Suspected foetal defects 8. Pre-existing maternal disease, e.g. diabetes mellitus, cardiovascular or renal disease |
| Date of first enrolment | 20/04/2009 |
| Date of final enrolment | 20/05/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Abteilung für Geburtshilfe der Universitätsfrauenklinik Jena
Jena
07743
Germany
07743
Germany
Sponsor information
University Hospital of Jena (Universitätsklinikum Jena) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Prof. Dr. med. Ekkehard Schleussner
Abteilung Geburtshilfe
Klinik für Frauenheilkunde und Geburtshilfe
Bachstr. 18
Jena
07743
Germany
| Phone | +49 (0)3641 9 33230 |
|---|---|
| ekkehard.schleussner@med.uni-jena.de | |
| Website | http://www.geburtshilfe.uniklinikum-jena.de |
"ROR" |
https://ror.org/035rzkx15 |
Funders
Funder type
Research council
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: FI 1635/1-1)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
