Clinical trial strives to provide optimal care during high-risk pregnancies

September 23, 2013, Wiley

Researchers are conducting a clinical trial to help determine the best timing of delivery in preterm pregnancies complicated by poor fetal growth. Preliminary results from the trial, which are published early online in Ultrasound in Obstetrics & Gynecology, demonstrate better than expected health outcomes in this high-risk group of fetuses.

Doctors are faced with a dilemma when deciding about the timing of delivery of a baby who does not grow adequately as a fetus, a condition called restriction. To deliver early potentially exposes the baby to risks associated with being born immature, but to deliver late risks allowing other serious problems to develop due to a lack of nourishment and oxygen in the womb.

Doctors usually decide on the timing of delivery for a small baby in a high-risk based on what they feel might be best for the baby, but without a solid basis in scientific facts.

Researchers designed a study—called the Trial of Randomized Umbilical and Fetal Flow in Europe (TRUFFLE)—in an attempt to help determine the best timing of delivery in preterm pregnancies complicated by fetal growth restriction. The study compares three groups of patients. In one group, the timing of delivery was based on monitoring the baby's heart rate. In the other two groups, timing was based on changes in the Doppler measurement of one of the baby's blood vessels. A standardized prenatal monitoring and delivery protocol was used for all women in the trial. Ultimately, the investigators hope to determine which monitoring practice is best for safeguarding development by measuring babies' neurological health at age two years.

In the meantime, the researchers now report early results from TRUFFLE performed in 20 European centers. The analysis includes 503 women who were pregnant for less than 32 weeks and whose babies were smaller than would be expected. The results revealed better health outcomes for the babies compared with recent reports: deaths were uncommon (8%), and most of the babies (70%) survived without severe health problems. Women with hypertension were at increased risk of having babies who died before or after birth or who had health issues.

"Although the effects of the different fetal monitoring practices on long-term neurodevelopment are not yet known, these management protocols would help effect a reduction in perinatal mortality and short term morbidity in pregnancies complicated by severe, early-onset fetal growth restriction," said lead investigator Chistoph Lees, MD of Queen Charlotte's & Chelsea Hospital, London. "This is the largest prospective study of outcomes in pregnancies complicated by severe, early-onset fetal growth restriction showing that, at least in part, a standardized antenatal management protocol was responsible for the improved neonatal outcomes," said co-author Basky Thilaganathan, MD, PhD, and Editor-in-Chief of Ultrasound in Obstetrics & Gynecology.

Dr. Lees noted that the two-year outcomes of the babies in the study will be available in 2014, which may provide clues about what management and monitoring strategy is best to optimize long term neurodevelopmental outcome.

Explore further: Study suggests tightening up of criteria for definition of intrauterine growth restriction

More information: "Perinatal morbidity and mortality in early-onset fetal growth restriction: cohort outcomes of the trial of randomized umbilical and fetal flow in Europe (TRUFFLE)." C. Lees, N. Marlow, B. Arabin, C. M. Bilardo, C. Brezinka, J. B. Derks, J. Duvekot, T. Frusca, A. Diemert, E. Ferrazzi, W. Ganzevoort, K. Hecher, P. Martinelli, E. Ostermayer, A. T. Papageorghiou, D. Schlembach, K. T. M. Schneider, B. Thilaganathan, T. Todros, A. Van Wassenaer-Leemhuis, A. Valcamonico, G. H. A. Visser, and H. Wolf, on behalf of the TRUFFLE Group. Ultrasound in Obstetrics & Gynecology; Published Online: September 23, 2013. DOI: 10.1002/uog.13190

Related Stories

Study suggests tightening up of criteria for definition of intrauterine growth restriction

February 11, 2013
In a study to be presented on February 14 at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting, in San Francisco, researchers will report that the practice of using an arbitrary Estimated Fetal ...

Study finds prior preterm delivery indicates subsequent baby will be small even if carried to term

February 9, 2012
In a study to be presented today at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting, in Dallas, Texas, researchers will report findings that indicate that women who deliver their first baby ...

Blood test for pregnant women could predict risk of having dangerously small babies

June 21, 2012
Researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) have found a protein in the blood of pregnant women that can predict if they are likely to have a fetus that doesn't grow ...

Study confirms recurrence of small-for-gestational-age pregnancies

February 11, 2013
In a study to be presented on February 16 at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting, in San Francisco, researchers will report findings that suggest women whose babies are small-for-gestational-age ...

Slow-growing babies more likely in normal-weight women; Less common in obese pregnancies

April 27, 2012
Obesity during pregnancy puts women at higher risk of a multitude of challenges. But, according to a new study presented earlier this month at the American Institute of Ultrasound in Medicine annual convention, fetal growth ...

Good asthma control during pregnancy is vital says new review

September 6, 2013
Good asthma management during pregnancy is vital during pregnancy as poor asthma control can have adverse effects on maternal and fetal outcomes, says a new review published today in The Obstetrician & Gynaecologist (TOG).

Recommended for you

Essure female sterilization device appears safe: study

January 23, 2018
(HealthDay)—Essure implants used in female sterilization have come under fire in recent years, with women reporting a wide array of problems to the U.S. Food and Drug Administration.

Study shows how fetal infections may cause adult heart disease

January 23, 2018
Recent studies have shown that infants born prematurely have a higher risk of developing heart disease later in life. Now, a study led by researchers at the University of Washington School of Medicine in Seattle shows that, ...

Rise in preterm births linked to clinical intervention

January 18, 2018
Research at the University of Adelaide shows preterm births in South Australia have increased by 40 percent over 28 years and early intervention by medical professionals has resulted in the majority of the increase.

New report calls into question effectiveness of pregnancy anti-nausea drug

January 17, 2018
Previously unpublished information from the clinical trial that the U.S. Food and Drug Administration relied on to approve the most commonly prescribed medicine for nausea in pregnancy indicates the drug is not effective, ...

New study finds 'baby brain' is real, but the cause remains mysterious

January 15, 2018
So-called "baby brain" refers to increased forgetfulness, inattention, and mental "fogginess" reported by four out of five pregnant women. These changes in brain function during pregnancy have long been recognised in midwifery ...

Sleep quality improves with help of incontinence drug

January 12, 2018
A drug used to curtail episodes of urinary incontinence in women also improves quality of sleep, a researcher at the Stanford University School of Medicine reports.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.