Condition category
Pregnancy and Childbirth
Date applied
02/04/2009
Date assigned
28/07/2009
Last edited
28/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Justine Sayuri Fitzgerald

ORCID ID

Contact details

Abteilung für Geburtshilfe der Universitätsfrauenklinik Jena
Bachstr. 18
Jena
07743
Germany
+49 (0)3641 514 320
fitzgerald@med.uni-jena.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FI 1635/1-1

Study information

Scientific title

Microparticle Orientated Risk Evaluation and Prediction of Pre-eclampsia Among Risk gravidas: a multicentre prospective phase I prognostic marker study

Acronym

MORE PrePARd

Study hypothesis

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

Local ethics committee (Ethik-Kommission der Universitätsklinikum Jena) approved on the 26th August 2008 (ref: 2370-08/08)

Study design

Multicentre prospective blinded phase I prognostic marker pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient 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

Condition

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

Phase

Phase I

Drug names

Primary outcome measures

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 trial start date

20/04/2009

Overall trial end date

20/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80 -100 pregnant women

Participant 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

Recruitment start date

20/04/2009

Recruitment end date

20/05/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Abteilung für Geburtshilfe der Universitätsfrauenklinik Jena
Jena
07743
Germany

Sponsor information

Organisation

University Hospital of Jena (Universitätsklinikum Jena) (Germany)

Sponsor details

Prof. Dr. med. Ekkehard Schleussner
Abteilung Geburtshilfe
Klinik für Frauenheilkunde und Geburtshilfe
Bachstr. 18
Jena
07743
Germany
+49 (0)3641 9 33230
ekkehard.schleussner@med.uni-jena.de

Sponsor type

Hospital/treatment centre

Website

http://www.geburtshilfe.uniklinikum-jena.de

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: FI 1635/1-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes