Clinical Trials and Research in Gynecology and Obstetrics

If we have a clinical trial underway that is suitable for you, your treating physician will offer you the opportunity to participate. Participating in a clinical trial is always voluntary.

Before you decide to participate, our staff will explain the clinical trial to you. You will also receive information about the clinical trial’s purpose, how it will be conducted, and the potential benefits and risks. You will have time to familiarize yourself with the clinical trial and get answers to any questions you may have before signing the consent form to participate.

You can withdraw from the clinical trial at any point without it affecting the treatment we provide you.

Gynecology

ProHyst – Infection after a hysterectomy

A postoperative infection is a possible complication related to hysterectomies, which is why prophylactic antibiotic therapy (cefuroxime) is administered during the surgery. This study explores if the risk of infection can be reduced by adding the antibiotic azithromycin to the treatment.

All women coming in for a hysterectomy for benign reasons, and who are not allergic to cefuroxime or azithromycin, are eligible for this study.

More information about the study will be provided when the patient is placed on the surgery waiting list, and if necessary, from Research Nurse Teija Karkkulainen, teija.karkkulainen@hus.fi.

Principal Investigators: Ninja Savonius, Päivi Rahkola-Soisalo, Liisu Saavalainen, Seppo Virtanen, and Tomi Mikkola.

Efficacy of Very Early Medical Abortion (VEMA) – a Randomized Controlled Non-Inferiority Trial

The purpose of the trial is to determine if there is a difference in treatment outcomes when abortion is performed at week 4 to 5 of pregnancy compared to a situation where abortion is performed only when an ultrasound scan can be used to confirm that the pregnancy is not located outside the uterus.

This is an international investigator-initiated multicenter trial.

Principal Investigator: Professor Kristina Gemzell-Danielsson, Karolinska Institutet, Stockholm

Principal Investigator in Finland: Professor Oskari Heikinheimo, Women's Hospital, HUS EudraCT: 2018-003675-35

Further information (in Finnish)

We are recruiting individuals aged between 40 and 65 with menopause-related hot flashes for the OASIS clinical trial

The purpose of the OASIS trial is to evaluate a hormone-free drug currently in development. The aim is to determine whether the investigational drug reduces the hot flashes associated with menopause safely and effectively.

If you meet the eligibility criteria and decide to participate in the trial, you may receive:

• the investigational drug (taken orally) and treatment related to the trial provided by the investigating physician and experienced trial staff free of charge;
• information about menopause and how to manage the symptoms of menopause; and
• reasonable compensation for your time and travel expenses.

If you would like to participate in the trial, please contact:

Pirjo Ikonen, pirjo.h.ikonen@hus.fi
Kaisu Luiro-Helve, kaisu.luiro-helve@hus.fi
Oskari Heikinheimo, oskari.heikinheimo@hus.fi

Pregnancy and Childbirth

HeBiCo Study

HeBiCo is a study on the impact of pregnancy-related factors on the body composition and subsequent health of newborn babies. The study is carried out in cooperation between HUS, the University of Helsinki, and the Finnish Institute for Health and Welfare (THL).

The study is open to all expectant mothers in the HUS area. During pregnancy, participants are asked to complete electronic questionnaires on topics such as nutrition, exercise, mood, and sleep quality. The body composition of infants born in the Women's Hospital can be measured with the PeaPod device. After pregnancy, participants are also asked questions about breastfeeding and their child's diet and development up until the age of two. Participants are given feedback on some of the questionnaires.

Further information (in Finnish)

Gynecologic Cancer

Study of Drug Therapy for Endometrial Carcinoma

Long title: MK-3475-C93 /GOG-3064 / ENGOT-en15: A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting

Patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma are being recruited for this study. These patients are treated with combination chemotherapy.

In this study, pembrolizumab is compared against this platinum-doublet chemotherapy. Pembrolizumab belongs to the group of immuno-oncology agents. Previous studies have shown that endometrial carcinomas of the dMMR type may be especially sensitive to immuno-oncology drug therapy.

The study is a Phase 3, international, randomized, open-label, active-comparator controlled multicenter study.

Individual patient's eligibility is assessed by their attending physician, who may suggest participation in the study.

Principal Investigator at HUS: Docent Heini Lassus, Women's Hospital and Comprehensive Cancer Center

Individual Treatment of Endometrial Carcinoma

PETREC (PErsonalized TReatment for Endometrial Carcinoma)

This is a national multicenter study conducted by the Finnish Gynecologic Oncology Group (FINGOG) established by the Finnish Society of Obstetrics and Gynaecology (SGY) for women with high-intermediate risk or high-risk endometrial carcinoma.

The purpose of the study is to compare the effectiveness of chemotherapy against the combination of chemotherapy and external pelvic radiotherapy in the treatment of high-risk cancer, and the effectiveness of internal vaginal radiotherapy against external pelvic radiotherapy in the treatment of intermediate-risk cancer.

Individual patient's eligibility is assessed by their attending physician, who may suggest participation in the study.

Principal Investigator at HUS and in Finland: Docent Mikko Loukovaara, Women's Hospital and Comprehensive Cancer Center