Research project—The ICARIS Trial
Impact on CAesarean section Rates following Injections of Sterile water:
Participant information and consent form
You are invited to participate in a research study of birth outcomes (e.g. normal birth or caesarean section) following sterile water injections (SWI) for back pain in labour. The research is funded by the National Health and Medical Research Council of Australia. The study requires 1,866 women to participate and is being conducted at five Queensland hospitals and one New South Wales hospital, specifically:
- Mater Mothers' Hospital, Brisbane
- Royal Brisbane and Women's Hospital
- Townsville Hospital
- Nambour Hospital
- Ipswich Hospital
- Royal Hospital for Women, Randwick, NSW
Please read this information carefully. Ask questions about anything that you don't understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend, your local health practitioner or midwife.
Participation in this research is voluntary. If you don't wish to take part, you don't have to. If you decide you would like to take part you will be asked to sign the consent form . By signing it you are telling us that you:
- understand what you have read
- consent to take part in this research project
- consent to be involved in the procedures described
- consent to the use of your health information as described.
You will be given a copy of this Participant Information and Consent Form to keep.
What is the purpose of the research?
The purpose of this study is to test the effect of sterile water injections (SWI) on labour. Sterile water injections are used, in some hospitals, to help relieve back pain in labour. Some studies have suggested that women who receive SWI may be less likely to require a caesarean section, although it is not known if this is because they received SWI or because of something else which happened in their labour. A large study, such as the ICARIS trial, will help to answer this question. Previous research suggests that the best approach is to compare SWI to a placebo such as normal saline (a weak salt water solution), that is commonly used to mix medications given by injection. When used in a similar way to SWI, normal saline provides only a very brief period of pain relief, or you may not experience any pain relief at all. We are using normal saline as a placebo because it has been used successfully this way in previous SWI research. Comparing groups who receive a 'real' treatment (sterile water) to those who receive no treatment, or a placebo (normal saline) is considered the best way to assess if a treatment works, or if it has a particular effect.
Can I choose which group I am in?
No. The study is a randomised, double blind trial, which means that no one, not even your midwives, doctors or the researchers will be able to choose your group or, know which treatment you received until the trial is completed. You will have an equal chance of being in either group.
Are there any risks?
Besides the brief pain of the injection, the research has been carefully designed to ensure there are very few, if any, risks. Previous SWI studies have not reported any harmful side effects to women or babies.
Why have I been asked?
All women giving birth at this hospital, who have had a normal pregnancy, and who do not have any complications (e.g. twins, diabetes or high blood pressure), and who request pain relief for back pain in labour, are being invited to participate in the trial.
Do I have to say yes?
Participation in the research project is voluntary. If you do not wish to take part, you do not have to.
If I say yes, what will it involve?
Participation in the study is voluntary. However, if you decide to participate, you will be randomly placed in either the group who receives either:
injections of sterile water (SWI)
injections of normal saline (the placebo).
Both procedures involve injecting a very small amount (0.1–0.3 millilitres) of either sterile water or normal saline just under the skin at four points in your lower back.
The injections may cause an intense, but brief, pain lasting about 30 seconds. The care you receive, including how your labour is managed, and the availability of other analgesic options, will not be affected by which type of injection you receive.
What will happen if I say no?
Nothing. We won't contact you about this research again and you will continue to receive the best care available at the hospital regardless of your decision.
When do I have to decide if I want to participate?
You may have received this information sheet during your pregnancy, just prior to, or in the early stages of your labour. You can decide whether you wish to take part in the research at any time. If you agree to participate in the study, a midwife will ask you to sign a consent form when you are in labour and asking for analgesia for your back pain. You will then be randomly allocated to either receive injections of sterile water or normal saline.
If I say yes, can I change my mind later?
You can change your mind about being in the study at any time and you don't have to say why.
What do I have to do?
If you decide to take part in the study, you will be asked to rate your back pain using a visual pain scale, otherwise known as a Visual Analogue Scale (VAS). This requires you to put a mark on a line marked 1–10, according to how severe you rate your back pain (from "no pain" to "worse pain I could imagine"). Your midwife will ask you to do this before, and at regular intervals after, you receive the injections.
On the first day after your baby's birth, we will ask you to complete a brief questionnaire about your experiences of receiving the injections. We would also like to contact you at about two months after your baby's birth to follow up on your experiences; at this point we would ask you to complete another questionnaire.
What other information about me will be collected?
The research team would like to collect information about your labour and birth and your baby's health, but only as it relates to this study. We would like to collect data on your ethnicity, the number of pregnancies and what types of births (e.g. vaginal birth or caesarean section) you have had in the past, information about this pregnancy (e.g. any illnesses or complications such as diabetes or high blood pressure), your labour and birth and information about your baby, such as weight and condition at birth, up until you leave hospital. With your consent, staff at your hospital and the Queensland Health Statistics Centre will provide us with the necessary details from your health records. Personal information, such as your name, will only be used to contact you after you have gone home from hospital, if you agree to participate in the follow-up questionnaire. Only your unique hospital record number will be provided to Queensland Health and your hospital to obtain your data, and this will be removed before use in the study. The information that you provide to us will be kept on a password protected computer database and will be aggregated (combined with anonymised information from other participants) before it is analysed by the researchers. At the end of the study we hope the aggregated data will be published in medical journals and presented at conferences, however the identity of individuals participating in the study will not be revealed.
- What will happen to the information about me?
All information (data) will be securely stored at Mater Research, Brisbane. Paper copies will be stored in a locked cabinet within the researcher's locked office. Electronic data will be stored on password protected computers. Only the researchers will have access to the data. All of your recorded health and personal details will be given a unique study code (number) which is randomly generated and known only to members of the research team. When the data is entered onto a protected database, it will be de-identified, which means we will never use your name, or that of family members, or any other personal details such as your address.
Can I access research information kept about me?
In accordance with relevant Australian and/or other state laws, you have the right to access the information collected and stored by the researchers about you. Please contact one of the researchers named at the end of this document if you would like to access this information.
What if I have concerns or a complaint?
This study has been reviewed and approved by the Royal Brisbane and Women's Hospital Human Research Ethics Committee (RBWH HREC) for Mater Mothers' Hospital and participating Queensland Health Hospitals. The study has also been approved by the Australian Catholic University HREC. Participants may contact the Ethics Coordinator on 07 3646 5490, should they have any complaints about the conduct of the research, or wish to raise any concerns. At its discretion, the Research Ethics Coordinator may contact the Patient Representative or Hospital Ethicist at your participating hospital.
If you wish to withdraw from the study or have any questions or concerns relating to your involvement, you are welcome to contact the chief investigator at the Mater Site: Professor Sue Kildea (Tel: 07 3163 6388 or email firstname.lastname@example.org) or the site coordinator at your participating hospital as detailed below:
|Mater Mothers' Hospital
||Phone: 07 3163 6313
|Royal Brisbane and Women's Hospital
||Prof Joan Webster
||Phone: 07 3636 8590
||Ms Beth Hartley
||Phone: 07 5470 5148
||Ms Annemarie Lawrence
||Phone: 07 4796 1111
||Ms Audrey Simpson
||Phone: 07 3810 1969
|Royal Hospital for Women
||Ms Donna Hartz
||Phone: 0414 469 335
If you do not feel comfortable contacting the research staff personally, you may contact the Research Support Office at Mater Health Services, where this study is based (07 3163 1585) or the RBWH HREC (07 3646 5490). Please mention that your call is about the ICARIS study. Any complaint you make will be treated in confidence and investigated fully and you will be informed of the outcome.
Mater acknowledges consumer consultation in the development of this patient information.
Last modified 19/11/2015.