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Research project
Survey of the length of the lower vaginal cervix in pregnant women
Information and enquiry regarding participation in the examination of the length of the lower vaginal cervix using vaginal ultrasound
Background and purpose
In Sweden, premature delivery (birth before week 37 of pregnancy) occurs in around 5-6 % of women who are expecting a baby. The earlier the birth, the greater the risk of diseases and impairment in the child. A shortened lower cervical cervix (cervix) at approximately 20 weeks of pregnancy may mean a greater risk of giving birth prematurely. In Sweden, no routine measurement is taken of the length of the lower vaginal cervix during pregnancy. An American study has shown that treatment with a natural hormone, progesterone, can reduce the risk of premature delivery in women with a short lower cervical cervix. However, it is not certain that the American conditions apply in Sweden. We would like to use a research study to find out whether this is the case. Would you like to participate in this research study?
Participation enquiry
We are approaching pregnant women who come to the Gynaecology Clinic at Östra Hospital in Gothenburg or the Gynaecology Clinic at NÄL (Northern Älvsborg County Hospital) in Trollhättan for routine ultrasounds at (approximately) 18 weeks of pregnancy. Women who are expecting twins are not being asked. The enquiry regarding participation is made at the time of an appointment at the Prenatal Clinic or no later than at the routine ultrasound examination.
What happens in the study?
At the time of the routine ultrasound examination at (approximately) 18 weeks of pregnancy, a vaginal ultrasound examination is also performed where the length of the lower vaginal cervix is measured by the midwife performing the ultrasound. During the examination you will lie in a gynaecology chair. An ultrasound rod is pushed into the vaginal sheath and through this you see the lower cervical cervix on a screen and can measure it. The examination is pain-free and is felt by most women to bring no discomfort at all. It takes approximately 5 minutes. The same examination is repeated 2-4 weeks later at (approximately) 22 weeks of pregnancy. The midwife also asks you questions about your lifestyle and health and about previous pregnancies. In participating, you give us permission to use this information and medical information that we retrieve from your records for statistical analysis.
If you do not want your lower cervical cervix examined, we ask your permission to still ask questions and use medical information that we retrieve from your records for statistical analysis. The information about you will be handled so that no unauthorised persons can access it.
How can I obtain information on my examination result?
You (or your midwife or doctor at the Prenatal Clinic) will not receive the result of the examination of your lower cervical cervix. The purpose of the study is to look at what will be referred to as a short cervix and what the length of the lower vaginal cervix means as regards the risk of premature delivery. The handling of your pregnancy will not be affected by the result of the measurement of your lower cervical cervix. In the rare cases where we find signs of the threat of miscarriage we will inform you.
Sahlgrenska Universitetssjukhuset
Område 1
Smörslottsgatan 1, 416 85 Göteborg
TELEFON växel 031-343 40 00
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What is routine treatment/extra element in addition to routine?
The lower cervical cervix is not measured routinely; this is being offered to women who come for routine ultrasound examinations.
What are the risks of being involved in the research project?
Participating in the study involves no medical risks. Be prepared to set aside a total of 15 minutes’ extra time for the examination at 18 weeks of pregnancy, including questions, undressing and dressing, any visits to the toilet, etc. The examination at 22 weeks of pregnancy is estimated to take a total of 15 minutes.
Are there any benefits?
Your participation may help to improve our options of preventing premature birth and thereby reducing ill-health and mortality in new-borns. You will see no personal benefits from participating.
Handling of data and confidentiality
The result of the examinationen will be noted in an electronic computer system and will be handled solely by responsible researchers. This information will be handled and stored in accordance with the Personal Information Act (PUL) so that no unauthorised persons can access it. All personnel who are involved in the study are subject to confidentiality.
Responsibility for personal details
Personal information in medical research is protected by confidentiality. You are entitled to obtain a registry extract once a year showing, which information has been collected and you are entitled to have erroneous information corrected or removed from the registry. The responsibility for the handling of your personal information falls to Sahlgrenska University Hospital. You can approach the hospital’s personal details representative (Susan Lindahl, Sahlgrenska University Hospital, Information Security Department, Torggatan la, 43135 Mölndal, Sweden, tel. +46 31-343 27 15) if you would like an extract of the personal information that is registered about you and any help with correction.
Voluntariness and remuneration
Participation in the screening is completely voluntary. Your care and treatment will not be affected by your decision. No financial remuneration will be given for participation.
Responsible researchers, further information
The research body (i.e. responsible for the study) is the Västra Götaland Region. The study has been approved by the ethics testing committee in Gothenburg.
Gothenburg, 02/09/2013
If you have any further questions, you can contact one of the following people:
Ulla-Britt Wennerholm, Doc., KK/Östra, Gothenburg,
Henrik Hagberg, Prof., KK/Östra, Gothenburg,
Bo Jacobsson, Prof., KK/Östra, Gothenburg, ,se
Pihla Kuusela, Specialist Doc., KK/Östra, Gothenburg,
Elisabeth Almström, Consultant, KK/NÄL, Trollhättan,
Carina Bejlum, Consultant, KK/NÄL, Trollhättan,
Martina Söderlund, research midwife,
Maria Hallingström, research midwife,
The Antenatal Unit, The Gynaecology Clinic, Sahlgrenska University Hospital/Östra Hospital, tel. +46 70 0823002