Microparticle orientated risk evaluation and prediction of pre-eclampsia among risk pregnancies

ISRCTN	ISRCTN92923842
DOI	https://doi.org/10.1186/ISRCTN92923842
Protocol serial number	FI 1635/1-1
Sponsor	University Hospital of Jena (Universitätsklinikum Jena) (Germany)
Funder	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: 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

Abteilung für Geburtshilfe der Universitätsfrauenklinik Jena
Bachstr. 18
Jena
07743
Germany

Phone	+49 (0)3641 514 320
Email	fitzgerald@med.uni-jena.de

Study information

Primary study design	Interventional
Study design	Multicentre prospective blinded phase I prognostic marker pilot study
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	Development of pre-eclampsia during current pregnancy. Final outcome will be assessed 6 weeks post-partum either by study doctor or attending doctor.
Key secondary outcome measure(s)	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.
Completion date	20/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	100
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes