Sex………… Mode of delivery………… Estimated fetal weight---
Birth Weight…………. Intrauterine growth restriction---Placenta weight --- intrauterine fetal death... Neonatal ICU Admission………….
Early Neonatal Death ...
WORK PLAN
ASSOCIATION BETWEEN PREECLAMPSIA AND β-hCG
N o.
Activity Jun
‘13
Jul‘1 3
Au g
‘13 Nov
‘13 Dec
‘13
Jul ‘14 Aug’
14
Sep‘14 Oct
‘14
Dec‘14 Jan
‘15
Feb
‘15
1 Proposal writing
xx xx
2 Ethical Clearance
xx
3 Submission of proposal to College for approval
xx
4 Data collection
xx xx xx xx
5 Data analysis
xx
6 Review of draft by supervisors
xx
7 Final write up
Xx
8 Submission of work to College
Xx
Association between β-hCG and preeclampsia – a case control study Name of Investigator: Dr. Ohazurike Ephraim O.
Facility Name: Lagos University Teaching Hospital
INFORMATION SHEET FOR THE PATIENT AND HER REPRESENTATIVE(S)
Title of Research:
Association of β-hCG and preeclampsia – a case control study
Site :
Labour ward and Accident and Emergency of the Lagos University Teaching hospital Idiaraba Lagos.
1. What is the purpose of the study? .
The purpose of this study is to determine the association between β-hcg and preeclampsia.
Preeclampsia is described as a disease of the placenta. β-hcg is a product of the placenta hence is β-hcg predictive of preeclampsia?
2. Why is this research being done?
Preeclampsia is a leading cause of death among pregnant women. Effort has been geared toward predicting and preventing the disease. The study is to determine any association between β-hcg and preeclampsia which may then serve as a basis for instituting preventive measures.
3. Why have you been invited?
You have been diagnosed to have preeclampsia. Your care giver has assessed that you are suitable for the study, but it is up to you whether or not you decide to take part.
4. Who is doing the study and who can you call if you have any questions or problems?
If you have any questions or problems you can contact the matron in charge of this maternity
You may also contact the Principal Investigator of the study at the following address:
Name: Dr. Ohazurike Ephraim
Address: Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Idi araba Lagos.
Telephone: 08037051800
5. A patient cannot be in this study if
- Pregnant woman with diabetes mellitus, chronic hypertension, peripheral vascular disease and/or antihypertensive treatment.
- Pregnant women with multiple gestation.
- Pregnant women with coexisting TB in pregnancy, ovarian cyst and fibroids in pregnancy.
- Consent to participate in the study has not been given.
6. What will happen during the study? About 5mls of blood samplewill be collected from your vein and the blood sample will be sent to the laboratory for processing.
7. What are the possible risks of being in this study?
The possible risk of being in this study are slight pain of needle prick while collecting the blood sample.
8. What are the possible benefits of being in the study?
We hope that estabilishing an association between β-hcg and preeclampsia will help in predicting preeclampsia and the knowledge that is gained will be put to use in the prevention of the disease .
9. What information do we keep private?
All information about you shall be kept private. The only people allowed to look at the information will be those who are running the study. The regulatory authorities may want to have a copy of documents which will have your name and this may include the signed Consent Form to ensure that the study is being done correctly. Your details will remain confidential and will be held in secure storage at the facility. We may publish the results of the study in a medical journal so that other medical professionals, including Physicians and Policy makers can benefit from the knowledge, but your personal information will not be included and there will be no way that you can be identified.
10. Can you change your mind about being in the study?
You can always withdraw from the study at anytime. You just need to say “I have decided I don’t want to be in this study now”. We hope that you will let us use information about how you got on the study, but if you don’t want us to use it please tell us.
11. What else do you want to know?
- This study has been approved by the Research and Ethics Committee of the Lagos University Teaching Hospital Idiaraba, Lagos. (Being processed).
12. What happens afterwards?
- If you would like to have a copy of the final results of this study, please let the research team know and they will ensure you receive a copy when it is published.
STUDY CONSENT FORM
Title of Research:
The association between β-hCG and preeclampsia
Patient Maternity ID Number Patient Study Number Name of Patient
1. I confirm that I have read and understood the information sheet for the above study and have had the opportunity to ask questions.
2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason and without my medical care or legal rights being affected.
3. I understand that sections of my medical notes may be looked at by responsible individuals involved in the study. I give permission for these individuals to have access to these records.
4. I give permission for a copy of this consent form, which contains my personal information, to be available to the study team for monitoring purposes only.
5. I agree tom take part in the above study.
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Name of Patient Date Signature/ Thumbprint (if unable to sign)
--- --- --- Name of person taking consent Date Signature
WITNESS ONLY REQUIRED IF PATIENT IS UNABLE TO SIGN
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Name of Witness Date Signature