Nav: Home

Better health for women involved in clinical trials

February 14, 2017

Women who participate in obstetric and gynaecology clinical trials experience improved health outcomes compared to those who are not involved in trials, according to research by Queen Mary University of London (QMUL). This is the case regardless of whether or not the treatment is found to be effective in the trial.

The review of 21 studies* included 20,160 women, and found that participants had 25 per cent better odds of improved health outcomes**, compared with non-participants. The researchers hope the results may lead to more clinicians offering trials to their patients and more women volunteering for trials in a research area that currently faces many challenges.

A clinical trial compares the effects of one treatment with another, and normally involves large numbers of volunteer patients in many centres. The results from trials help doctors understand how to treat a particular disease or condition, and are necessary to test the safety and efficacy of new treatments before they are brought into general use.

Research on the effect of participation in trials has previously not consistently shown evidence of benefit. This may be because previous work has analysed data from all medical specialities grouped together which could include wide variations in the way care is given within and outside trials.

The review, which focuses on pregnancy and reproductive health, is published in BJOG: An International Journal of Obstetrics and Gynaecology (BJOG) and is believed to be the first of its kind. It found that the beneficial effect of participating in a trial was largest when it was a high quality clinical trial, and when the trial tested an intervention that was unavailable outside of the trial.

Lead researcher Professor Khalid Khan from QMUL said: "Clinical trials are often perceived as 'experiments', 'risky' or 'dangerous'. However, our findings challenge these misconceptions, and show not only that they are safe but that there is a significant benefit associated with participation, with overall 25 per cent chance of better health outcomes."

"Interestingly, we also found that participants still experienced benefits irrespective of whether the treatment in the trial was found to be effective or not."

Worldwide over 69 million babies are born annually (776,000 in the UK), but only a small proportion of pregnant women are entered into research studies. Pregnancy and reproductive health is an area with unique challenges, dealing with controversial topics (IVF, contraception, abortion), a lack of research funding (less than one per cent of UK government spend) and ethical/legal implications (studies involving pregnant women). As such, research results from general medicine often inform practise in pregnancy patients, which does not always lead to optimum medical care.

Ngawai Moss was a participant of QMUL's EMPiRE trial - a study looking at how to control seizures in pregnant women with epilepsy. She said: "I'm very happy that I took part in a clinical trial and would do it all over again without hesitation. I would tell women who are considering whether to join a clinical trial, that the investment of their time is really quite minimal for the reward.

"In my case, the trial was pretty straightforward and mainly involved monthly visits to fill in a questionnaire and have a blood test. It was reassuring to be able to see a medical professional on a regular basis, especially as I had a complicated pregnancy. It meant I had access to the team's medical insight, advice and support on general pregnancy-related issues."

Professor Khalid Khan from QMUL added: "Women in general are often unrepresented in research, so we hope this may lead to a shift in attitudes and encourage more clinicians and women to be involved in trials. We also hope that patients recognise that research can be even safer than routine healthcare, due to the additional safeguards in place."

The researchers say that it is important to remember that research can still be associated with risk, and it is the duty of researchers and clinicians to inform patients of the potential risk and benefit of engagement in research.
-end-
QMUL's IBIS 3 Feasibility Study is currently looking to recruit post-menopausal breast cancer survivors. The clinical trial will test three types of medicines in 18 hospitals around the UK to find out the best way to prevent the late recurrence of breast cancer. More information on joining the trial is available on the website or by contacting ibis3help@qmul.ac.uk or 020 7882 3510.

For more information, please contact:

Queen Mary University of London Press Office
press@qmul.ac.uk
Tel: +44 (0) 20 7882 3004

Notes to the editor

* Example trials analysed in the review included a trial on the use of heparin and aspirin for women with in vitro fertilization implantation failure, and a trial comparing the success of hormone releasing implants with copper-intrauterine devices as contraceptive methods.

** The review included maternal and neonatal health outcomes such as stillbirth, pre-eclampsia, pregnancy rates, Neural tube defect, spontaneous fetal death, treatment satisfaction, treatment acceptability, infant death, caesarean section rate, successful surgery, severe bleeding (abortion), and fetal outcomes.

Research paper: 'Participation in clinical trials improves outcomes in women's health: A systematic review and meta-analysis'. Simrit K. Nijjar, Maria I. D'Amico, Noshali A. Wimalaweera, Natalie A.M. Cooper, Javier Zamora, Khalid S. Khan. BJOG 2017. DOI: 10.1111/1471-0528.14528. Once published, the article can be found here: http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.14528/full

About Queen Mary University of London

Queen Mary University of London (QMUL) is one of the UK's leading universities, and one of the largest institutions in the University of London, with 21,187 students from more than 155 countries.

A member of the Russell Group, we work across the humanities and social sciences, medicine and dentistry, and science and engineering, with inspirational teaching directly informed by our research. In the most recent national assessment of the quality of research, we were placed ninth in the UK (REF 2014).

As well as our main site at Mile End - which is home to one of the largest self-contained residential campuses in London - we have campuses at Whitechapel, Charterhouse Square, and West Smithfield dedicated to the study of medicine, and a base for legal studies at Lincoln's Inn Fields.

We have a rich history in London with roots in Europe's first public hospital, St Barts; England's first medical school, The London; one of the first colleges to provide higher education to women, Westfield College; and the Victorian philanthropic project, the People's Palace at Mile End.

Today, as well as retaining these close connections to our local community, we are known for our international collaborations in both teaching and research.

QMUL has an annual turnover of £350m, a research income worth £125m (2014/15), and generates employment and output worth £700m to the UK economy each year.

Queen Mary University of London

Related Pregnancy Articles:

Paracetamol during pregnancy can inhibit masculinity
Paracetamol during pregnancy can inhibit masculinity Paracetamol during pregnancy can inhibit the development of 'male behavior' in mice.
The cost of opioid use during pregnancy
A new study published today by the scientific journal Addiction reveals that the incidence of neonatal abstinence syndrome -- often caused by mothers using opioids during pregnancy -- is increasing in the United States, and carries an enormous burden in terms of hospital days and costs.
New study: Pre-pregnancy BMI directly linked to excess pregnancy weight gain
It's well known that excessive weight gain during pregnancy can have a lasting negative impact on the health of a mother and her baby.
Pregnancy-specific β1-glycoproteins
Development of new strategies and novel drug design to treat trophoblastic diseases and to provide pregnancy success are of crucial importance in maintenance the female reproductive health.
Should hypothyroidism in pregnancy be treated?
When a woman becomes pregnant, many changes occur in her body.
Pre-pregnancy progesterone helps women with recurrent pregnancy loss
Women who have had two or more unexplained miscarriages can benefit from natural progesterone treatment before pregnancy, a new a study from the University of Illinois at Chicago shows.
Male pipefish pregnancy, it's complicated
In the upside-down world of the pipefish, sexual selection appears to work in reverse, with flashy females battling for males who bear the pregnancy and carry their young to term in their brood pouch.
Pregnancy leads to changes in the mother's brain
A study directed by researchers from the UAB and IMIM are the first to reveal how pregnancy causes long-lasting alterations in brain structure, probably related to improving the mother's ability to protect and interact with the child.
MRIs during pregnancy and outcomes for infants, children
In an analysis that included more than 1.4 million births, exposure to magnetic resonance imaging (MRI) during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood, although gadolinium MRI at any time during pregnancy was associated with an increased risk of a broad set of rheumatological, inflammatory, or skin conditions and, possibly, for stillbirth or neonatal death, according to a study appearing in the Sept.
The benefits of exercise during pregnancy
Women who exercise during pregnancy are more likely to deliver vaginally than those who do not, and show no greater risk of preterm birth.

Related Pregnancy Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Moving Forward
When the life you've built slips out of your grasp, you're often told it's best to move on. But is that true? Instead of forgetting the past, TED speakers describe how we can move forward with it. Guests include writers Nora McInerny and Suleika Jaouad, and human rights advocate Lindy Lou Isonhood.
Now Playing: Science for the People

#527 Honey I CRISPR'd the Kids
This week we're coming to you from Awesome Con in Washington, D.C. There, host Bethany Brookshire led a panel of three amazing guests to talk about the promise and perils of CRISPR, and what happens now that CRISPR babies have (maybe?) been born. Featuring science writer Tina Saey, molecular biologist Anne Simon, and bioethicist Alan Regenberg. A Nobel Prize winner argues banning CRISPR babies won’t work Geneticists push for a 5-year global ban on gene-edited babies A CRISPR spin-off causes unintended typos in DNA News of the first gene-edited babies ignited a firestorm The researcher who created CRISPR twins defends...