Patient information leaflet
Ectopic pregnancy: medical treatment versus expectant management
UK Patient information leaflet AMC March 06
METEX study
Ectopic Pregnancy: medical treatment versus expectant management Dear Madam, As your doctor will have told you, we think you might be suffering from ectopic pregnancy according to the ultrasound findings and the persistent pregnancy hormone blood levels. Surgery for ectopic pregnancy is necessary when the complaints are quite serious and/or there are signs of tubal damage. Your ectopic pregnancy has been discovered before clinical deterioration. Therefore, surgery is not necessary. An alternative treatment option is medical treatment. You can even be managed expectantly, based on the knowledge that many small ectopic pregnancies with low pregnancy hormone blood levels will resolve spontaneously.
Research question We would like to ask you to participate in a scientific study concerning two non-surgical treatments of ectopic pregnancy. Our research should answer the question whether in women with ectopic pregnancy with low and stable pregnancy hormone blood levels medical treatment with the drug methotrexate is superior over expectant management.
Advantages and disadvantages of medical treatment Medical treatment comprises one single intramuscular injection with the drug methotrexate. Methotrexate arrests cell growth and specifically has effect on highly proliferative tissues, ie. pregnancy tissue. Treatment will be carried out in the outpatient clinic. The advantage of treatment with systemic methotrexate is that it is a proven effective treatment for various types of ectopic pregnancies. A possible disadvantage is that one methotrexate injection is not effective enough and that additional methotrexate injections are necessary. This will soon be clear through weekly blood tests. There is a small chance that medical treatment fails or that severe abdominal pain occurs during treatment. Then you have to be operated upon after all. Some people might suffer from side effects of the drug; irritation of mouth and eyes and nausea or diarrhoea. Sometimes blood tests will show irritation of the liver or kidney and a decrease of blood count. All these side effects are temporary. There are no harmful effects on fertility or next pregnancies. We do advise you to avoid pregnancy within three months after methotrexate treatment.
Advantages and disadvantages of expectant management The advantage of expectant management is avoiding treatment and its inherent side effects because the ectopic pregnancy can be a self limiting process. After successful management you may become pregnant again immediately. The disadvantage is the uncertainty whether the ectopic pregnancy resolves spontaneously. This will soon be clear through weekly blood tests. In case the pregnancy hormone blood level rises, treatment needs to be started (methotrexate or surgery). In case the pregnancy hormone blood level remains stable or declines, we will continue to manage you expectantly. Whenever severe abdominal pain occurs, even in spite of falling pregnancy hormone blood levels, surgical treatment may be necessary.
If you participate in this study If you want to participate in this study, we need your informed consent. Firstly, we will perform a blood test checking your blood count and your liver and kidney function. If there are any UK Patient information leaflet AMC March 06
METEX study
abnormalities, you can not participate in the study. If there are no abnormalities, the computer will decide if you will be treated with methotrexate or with expectant management. Your pregnancy hormone blood level will be checked weekly. If it becomes undetectable, you are cured. During the study, we would like you to fill in some questionnaires. Before randomization, after one week, four weeks and three months you will be given a questionnaire concerning your mental and physical health during and after treatment. After six, 12, 18, and 24 months, we would like to know if you tried to conceive and if you got pregnant again.
Privacy To contact you, we would also like to know your e-mail address and telephone number. Please, could you provide this on the informed consent form? Obviously, we will be careful with your personal information. Your medical data will be encoded to guarantee your privacy. A certified representative of the trial bureau at the Academic Medical Center Amsterdam has limited insight in your medical record.
Informed consent Naturally, scientific research is only allowed with your permission. We hope that you understand the research question and are willing to participate in this study. Participation is on a voluntary basis. You are free to withdraw at any time without giving a reason. This will not have any consequences on your further treatment. Any questions can be asked to your local doctor and/or an independent gynaecologist K. Boer, MD, PhD, telephone 020-5663654. If you are willing to participate in this study, please sign the accompanying form. On behalf of the METEX study group, Academic Medical Center, University of Amsterdam P.J. Hajenius, MD, PhD, gynaecologist Prof. F. van der Veen, MD, PhD, gynaecologist Department of Obstetrics and Gynaecology Center for Reproductive Medicine
Included is a standard Dutch information leaflet about insurance, which is obligatory for a randomised controlled trial in the Academic Medical Center, Amsterdam.
* Official research title: The METEX study; methotrexate versus expectant management in women with ectopic pregnancy
UK Patient information leaflet AMC March 06
METEX study
Informatie over verzekeringstechnische aspecten voor patiënten die deelnemen aan onderzoek. Overeenkomstig de Wet medisch-wetenschappelijk onderzoek met mensen heeft het AMC Medical Research B.V. voor medisch-wetenschappelijk onderzoek een verzekering afgesloten die door het onderzoek veroorzaakte schade door dood of letsel van de proefpersoon dekt. • •
Dit betreft schade die zich tijdens of binnen vier jaar na de deelname aan het onderzoek openbaart en gemeld is binnen vier jaar na beëindiging van de deelname aan het onderzoek. Het bedrag waarvoor de verzekering is afgesloten bedraagt € 450.000 per proefpersoon, met een maximum van € 3.500.000 voor het hele onderzoek en € 5.000.000 voor schade tengevolge van medisch-wetenschappelijk onderzoek die per verzekeringsjaar wordt gemeld.
De verzekering biedt dekking • Voor schade tengevolge van de verwezenlijking van de aan deelname aan het wetenschappelijk onderzoek verbonden risico’s waarover men niet schriftelijk is ingelicht; • Voor schade tengevolge van de verwezenlijking van de risico’s waarover de deelnemer wel is ingelicht, maar die zich in ernstiger mate voordoet dan is voorzien; • Voor schade tengevolge van de verwezenlijking van de risico’s waarover de deelnemer wel is ingelicht, maar die zeer onwaarschijnlijk werd geacht. De verzekering biedt geen dekking • Voor schade die het gevolg is van het uitblijven van een vermindering van de gezondheidsproblemen van de proefpersoon, dan wel het gevolg is van de verdere verslechtering van de gezondheidsproblemen, indien de deelname aan het wetenschappelijk onderzoek plaatsvindt in het kader van de behandeling van deze gezondheidsproblemen; • Voor schade door aantasting van de gezondheid van de proefpersoon waarvan aannemelijk is dat deze zich ook zou hebben geopenbaard wanneer de proefpersoon niet aan het onderzoek had deelgenomen; • Voor schade tengevolge van deelname aan medisch-wetenschappelijk onderzoek waarbij in de kring van beroepsgenoten gebruikelijke handelingen op het gebied van de geneeskunst met elkaar worden vergeleken en aannemelijk is dat de schade het gevolg is van de toegepaste handelingen; • Voor schade die zich bij een nakomeling van de proefpersoon openbaart als gevolg van een nadelige inwerking van het onderzoek op de proefpersoon of de nakomeling; • Voor schade die het gevolg is van het niet of niet volledig opvolgen van aanwijzingen en instructies door de proefpersoon, indien de proefpersoon daartoe althans in staat is. De verzekering dekt uitsluitend de schade van natuurlijke personen. De dekking van specifieke schades en kosten is tot bepaalde bedragen beperkt. Om aanspraak te kunnen maken op schadevergoeding dient de proefpersoon in geval van vermeende schade als gevolg van het onderzoek dit te melden aan: Naam verzekeraar: · Centramed B. A. Adres verzekeraar: Prinses Beatrixlaan 35, 2595 AK ’s-Gravenhage Polisnummer: 620.872.806 Voorts wordt de proefpersoon verzocht dienaangaande contact op te nemen met mw. dr. P. J. Hajenius, gynaecoloog AMC (tel. 020-5663654) en mw. J. van Dijk, AMC-MR b.v. (tel. 0205665036) UK Patient information leaflet AMC March 06
METEX study
Informed Consent form: Ectopic pregnancy: medical treatment versus expectant management
My doctor, ………………………………………….(name) explained the advantages and disadvantages, risks and discomfort of this study. I have read the information leaflet and had the opportunity for asking questions. I had enough time to consider. I understand the sort and aim of the study. I understand participation is on a voluntary basis and I am allowed to discontinue with the study whenever I want to. Such a decision will not interfere with my treatment for this disease or with the care by my doctor. I understand medical data of relevance for this study will be used for scientific research and might be published. If my privacy is guaranteed, I agree with this. My doctor,.......................................................(name) is allowed to give insight in relevant parts of my medical file to a certified representative of the department of Obstetrics and Gynaecology of the Academic Medical Center Amsterdam, provided that the privacy of these data will not be harmed by these persons. I agree with the insurance conditions (see other site) especially the condition about the limitation of the payments in case of damage. I give informed consent on a voluntary basis to participate in this study Name patient:
e-mail address:
Date
Phone number:
:
Signature:
Mobile phone number:
I confirm I explained this study to the following patient ………………………………… (name) Name doctor: Date: Signature:
UK Patient information leaflet AMC March 06
METEX study
