Clinical Trials and Research in Gynecology and Obstetrics

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

Are you under the age of 60 and on hormone replacement therapy for menopause?

The need for hormone therapy to maintain a good quality of life is recommended to be tested every few years by discontinuing the treatment for a couple of months. We study the effects of this pause in treatment on the functioning of the heart and vascular system, the recurrence of menopause symptoms, and quality of life.

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

Research Nurse Teija Karkkulainen Tel. 050 427 0665, teija.karkkulainen@hus.fi

The person in charge of the trial is Professor Tomi Mikkola, HUS Women's Hospital, Helsinki

Further information (in Finnish)

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)

SYKE Study

In Finland, 8–10% of pregnancies continue beyond week 41+5 of pregnancy, and being overdue is the most common reason for inducing labor. As the pregnancy continues beyond the due date, placental function begins to gradually deteriorate.

As per the current guidelines, expectant mothers in Finland attend the first overdue control in a maternity hospital during week 41+5 of pregnancy, and labor is typically induced during weeks 41+5–42+1 of pregnancy. According to international studies, inducing labor as early as in week 41 of pregnancy could reduce the number of childbirth complications. On the other hand, non-induced labor usually proceeds faster. The optimal time or method for the induction of labor in a first-time pregnancy becoming overdue is not yet known.

In our study, we compare the earlier (week 41+0 of pregnancy) and later (weeks 41+5–42+1 of pregnancy) use of induction and try to determine the optimal induction method. We invite all study participants to an additional antenatal appointment during week 41+0 of pregnancy. During the visit, an ultrasound examination will be performed.

Further information (in Finnish)

ALBINO Study

A new clinical trial is investigating whether allopurinol—a drug used to treat gout—protects the brains of newborns.

Lack of oxygen during childbirth can damage the newborn and lead to neurological disability or death. A total of 1 to 4 newborns out of 1000 are exposed to lack of oxygen during childbirth.

The Women's Hospital and Jorvi Hospital of HUS are participating in the ALBINO study, which investigates whether administration of the gout drug allopurinol together with other therapies reduces permanent neurological damage sustained by newborns in situations where the infant did not get enough oxygen during childbirth. Based on animal studies and preliminary studies involving 196 newborns, allopurinol is an effective drug. The drug has not been shown to cause significant harm.

Further information (in Finnish)

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

Joensuu, Johanna. 29.9.2023. Factors behind the childbirth experience - influence on future reproduction (helsinki.fi)

Peuranpää, Pirkko. 24.11.2023. Maternal and paternal factors in recurrent pregnancy loss (helsinki.fi)

Place, Katariina. 8.12.2023. Labor induction at term and beyond : effects on vaginal delivery rate, adverse outcomes, and childbirth experiences — Helsingin yliopisto (helsinki.fi)

Rissanen, Annu-Riikka. 26.5.2023. Twin pregnancies in Finnish birth cohorts during the years 1987-2018 : maternal and fetal outcomes — Helsingin yliopisto (helsinki.fi)

Sahrakorpi, Niina. 9.6.2023. Determinants of Health-Related Quality of Life from pregnancy to early years of motherhood : Focus on Obesity and Gestational Diabetes — Helsingin yliopisto (helsinki.fi)

Tulokas, Sari. 6.10.2023. Mid-Urethral Sling Operation for Stress Urinary Incontinence : Long-Term Re-Operation Risk and Effects of Pregnancy or Hysterectomy (helsinki.fi)

Vilkko, Riitta. 10.3.2023. Busy day effect on the Finnish obstetric ecosystem — Helsingin yliopisto (helsinki.fi)

Check out our research publications on the University of Helsinki website.