PATIENTINFORMATION FOR A SCIENTIFIC STUDY INTO THE EFFECTS OF INTERVENTION OR NON INTERVENTION WHEN HIGH BLOOD PRESSURE AND/OR PRE-ECLAMPSIA ARE PRESENT (HYPITAT).

Responsible investigators: Drs. C. Koopmans tel.: 050-3616161 and Drs D. Bijlenga tel.: 020-5667456

and local scientist

Dear Ms,

In addition to the conversation with your physician you herewith receive the written information on the study for which your collaboration has been requested. We do not ask you to take a decision immediately. We suggest that you take your time before you decide to participate. You may also want to discuss your participation with your partner, family, general practitioner or others.

In case you want a second opinion from a physician who is not directly involved in this study, you can find the name and the phone number of this independent physician on the last page of this information.

Introduction

At your check-ups during pregnancy you have been diagnosed with high blood pressure or pre-eclampsia. However, your baby is in good condition because it has a normal heart rhythm pattern. When a pregnant women with high blood pressure or pre-eclampsia is almost due, often the choice will be made to induce labor at an earlier stage as a precaution. However it is not always clear if this is best for the mother and/or for the baby. Termination of pregnancy occurs through induction of labour. Other studies have shown that induction of labour for other reasons increasesses the chance of caesarian section or ventous extraction. The induction of labor has been linked to possible disadvantages. Beside the fact that the baby is born at shorter pregnancy duration, there is an increased chance of caesarian section.

Aim of the research project

The aim of the research project is to study the effects of early induction of labour yes or no, during high blood pressure and/or pre-eclampsia.

Study set-up

In case you decide to participate in this study, random selection will decide whether labor will be induced early for you or not. If you are in the early labor induction group an appointment will be made soon. If you in are in the other group the spontaneous course of the pregnancy will be awaited. But in any case your condition and that your baby will be monitored closely. The groups with be compared with each other after delivery. Moreover we ask you to fill in some questionnaires in the course of 2 years after delivery. By means of these questionnaires we want to assess the health of your child. Filling out these questionnaires takes approximately a half hour.

Burden for the patient

Participation in this study does not increase the burden of pregnancy. Depending on the random selection you will get the standard treatment, such as that is given already (intensive check-ups), or the alternate treatment, where we pursue delivery. The burden of the treatment you were randomised for is one of the points to be evaluated. No separate hospital visits are necessary. Filling in the questionnaires costs approximately a half hour of your time. No extra blood drawing will be performed within the framework of this study.

Possible risks of the study

Both treatments of the suspected growth retardation of the baby, the waiting policy and the direct induction of labor, are frequently applied in daily practice. According to current insights we do not expect that the risk of complications for mother or child are different for both treatments.

Possible advantages of the study

You will not benefit personally from participation to this study. However, the data acquired in this study may be beneficial for other patients with at suspected growth retardation in the future.

Voluntarity of participation

Your collaboration to this study is voluntary. In case you decide to participate in this study, you have the right to withdraw your permission at any time. There is no need to give any reason for this, however, you will be asked to inform your physician immediately. He will discuss with you whether stopping will necessitate another treatment.

Your physician may also stop your participation in case he feels this is necessary with respect to your health. Your physician will discuss this with you. If during the study new information comes available, your physician will discuss this.

In case you do not take part in this study your physician with discuss with you which treatment will be suitable for you.

Whether you participate or not will not have any consequences for the relationship with your physician.

Confidentiality of the data

You are assured that all data are encrypted and cannot be traced back to you and are treated confidentially. Furthermore, unauthorized persons will not be able to examine your data. The results of this study may be used in a scientific publication, but the data cannot be related to you personally.

Insurance

The hospital has arranged an insurance from which possible damage as a result of the research can be paid. If you find that you have experienced damage as a consequence of participation in this study you should contact the investigators. Information on insurance is given in the appendix.

In case you still have questions concerning this study you can always contact your physician, the investigator or the independent physician.

Dr.XXXXXXXX Tel.:……….., is prepared to act as an independent physician and can answer your questions and give extra information concerning this protocol.

For general information on participation to scientific research we refer you to the brochure "Asked for medical-scientific research". In case you decide to take part in this research we kindly ask you to sign (the informed consent) on the next page. With the signature you are not obliged to anything (your signature is not 'binding'), but indicates that you have received and understood this information and that you know what is expected of you.

Name research doctor: Drs. C.M.KoopmansName independent doctor:

gynecologist

Department of Obstetrics Department of Obstetrics

Phone number 050-3616161Phone number......

Name contactperson:local researcher

gynecologist

Department of Obstetrics

Phone number:……………..

Informed Consent

for participation in the scientific research to

HYPITAT study, p 04/210)

-I have been informed satisfactorily concerning the study. I have read the written information carefully. I have had the opportunity to ask questions concerning the study. My questions have been answered satisfactorily. I have been able to think about the participation properly. I have the right to renege on my decision at any time without giving any reason.

For the patient:

I give/ don't give authorization for participation to the research. *

Surname and initials: ......

Date of birth: ......

Address ......

Phone number/e-mail: ......

Cell phone number: ......

Name and address parents/next of kin: ......

(if authorization): ......

Signature: ...... Date:

If NO authorisation:

-I do / don't have any objection against filling in the questionnaires. *

-I do / don't have any objection against answering data concerning the labour researcher. *

please enter your address data and (mobile) phone numbers so that we can send you over the next 2 years the questionnaire.

Surname and initials: ......

Date of birth: ......

Address ......

Phone number/e-mail: ......

Cell phone number: ......

Name and address parents/next of kin: ......

(if authorization): ......

cross out what NOT is not applicable.

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For the physician:

-Signatory states that abovementioned individual has been informed both orally and in writing about the above-mentioned study. He/she declares that a premature stopping of the participation by above-mentioned person, does absolutely not influence the care to which she is entitled to.

Name : ......

Function: ......

Signature: ...... Date: