Status:
UNKNOWN
IMproved PRegnancy Outcome by Early Detection
Lead Sponsor:
Louise Kenny
Collaborating Sponsors:
Keele University
University of Liverpool
Conditions:
Pre-eclampsia
Pregnancy
Eligibility:
FEMALE
16+ years
Brief Summary
The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia. This will involve a multice...
Detailed Description
Sample size calculations have been considered extensively and given the complexity of the study; there is no single simple solution. For the purpose of sample size estimation in the overall study, we ...
Eligibility Criteria
Inclusion
- Nulliparous.
- Singleton pregnancy, between 9+0 and 16+6 weeks' gestation.
- Signed informed consent.
Exclusion
- Unsure of last menstrual period (LMP) and unwilling to have ultrasonography screening (USS) at ≤ 20 weeks.
- ≥ 3 miscarriages.
- ≥3 terminations of pregnancy.
- Known or suspected major fetal anomaly/abnormal karyotype.
- Essential hypertension treated pre-pregnancy.
- Moderate-severe hypertension at booking (BP \>160/100 mmHg).
- Diabetes mellitus.
- Renal disease.
- Systemic lupus erythematosus.
- Anti-phospholipid syndrome.
- Sickle cell disease.
- HIV positive.
- Hepatitis B or C positive.
- Major uterine anomaly.
- Cervical suture in situ.
- Knife cone biopsy.
- Long-term steroids.
- Treatment with low-dose aspirin.
- Treatment with heparin/LMW heparin.
- Lack of informed consent.
- After recruitment, if the woman is found to be outside the stated gestation limits for the IMPROvED 1st visit of 9 weeks 0 days to 13 weeks 6 days she will be retained in the study if she is willing to take part in the second and third visit and is otherwise eligible. There is one pre-specified criteria for discontinuation of a participant. If a woman is recruited into the IMPROvED study and later identified as having a pregnancy exclusion criterion, i.e., ≥ 3 miscarriages, ≥ 3 TOPS, or using low-dose aspirin at the time of recruitment, she shall be excluded. However, women diagnosed during the pregnancy but after recruitment with an exclusion criterion, e.g., diseases such as renal disease, anti-phospholipid syndrome, etc. shall be retained within the study. Women who are recruited but later discontinue from the study do not count towards recruitment targets for each centre. Accordingly, such dropouts must be replaced.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01891240
Start Date
November 1 2013
End Date
April 1 2018
Last Update
November 8 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Cork University Maternity Hospital, University College Cork
Wilton, Cork, Ireland
2
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
3
Karolinska University Hospital Huddinge, Karolinska Institute
Stockholm, Sweden
4
Liverpool Women's Hospital, University of Liverpool
Liverpool, Merseyside, United Kingdom