1 In 50 Babies Has Birth Defect: Report Highlights Worrying Gaps In Regional Monitoring

Main Category: Pediatrics / Children's Health
Also Included In: Heart Disease;  Neurology / Neuroscience;  Pregnancy / Obstetrics
Article Date: 15 Dec 2011 - 0:00 PST

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More than one baby in every 50 is born with a birth defect (congenital anomaly) according to the latest annual report by the British Isles Network of Congenital Anomaly Registers (BINOCAR) - significantly more common than previously reported estimates of around one in 80.

The study* - led by researchers at Queen Mary, University of London and commissioned by the Healthcare Quality Improvement Partnership (HQIP) - is the most up-to-date and comprehensive of its kind, bringing together existing data in England and Wales from 2005 to 2009.

However, the report's authors remain concerned that data for substantial parts of the country, including London, are not currently monitored, meaning large regional increases in birth defects could go unnoticed and their causes not investigated.

"This is a major issue," commented Joan Morris, Professor of Medical Statistics at Queen Mary, University of London and editor of the report. "It is essential we know how many babies are being born with anomalies and how good their survival is across the whole country, so we can identify ways to reduce the occurrence of anomalies and plan for the care of these babies."

This national report includes data from five regional registers and two disease specific national registers†. Three additional registers exist and it is hoped that with further funding they will contribute data to future reports. Currently there are no registers in London and the South East, the North West and East Anglia.

Professor Elizabeth Draper from the University of Leicester who is Chair of BINOCAR commented: "This report is important, not least because it highlights the need to increase the number of regional registers in England. We are very grateful for the ongoing support from HQIP, but to provide national coverage will require a sustained commitment of additional resources. Funding for national surveillance of congenital anomalies is being considered as part of the surveillance program in Public Health England and we hope it will be in place by April 2013."

The number and types of birth defects have been monitored since the thalidomide epidemic in the 1960s. Under the original system, cases were notified to the Office for National Statistics by doctors, nurses, midwives and health visitors. Since the 1980s, regional registers have been established in some parts of the country to actively collect data from hospitals, laboratories and health records.

In the intervening years, lack of strategic funding coupled with a lack of support at national level has led to the closure of the national system and some of the regional registers. This report collates data from five regional registers, which together cover 28 per cent of the population of England and Wales, leaving the vast majority of birth defects unreported. Previous estimates, based on data from the Office for National Statistics, suggested that 1.3 per cent of babies have a birth defect. The new report indicates that the figure is more than two per cent. The researchers estimate that there were at least 14,500 babies born with birth defects in England and Wales in 2009. The most common defect was congenital heart disease, which affects at least five in 1,000 births. Some cases require major operations and around six per cent of babies born with a heart defect will die before the age of one. Neural tube defects, such as spina bifida, affect one in 1,000 babies, many of these may be prevented by women taking folic acid supplements before becoming pregnant. Gastroschisis - a defect where the intestines develop outside the abdomen - affect one in 1,000 babies. Regional monitoring has shown that this condition has become more common in some areas including Wales and that babies born to younger mothers are at greater risk. Over half of all major birth defects were detected during pregnancy. Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Vaginal Progesterone Reduces Preterm Birth, Neonatal Morbidity And Mortality In Women At Risk

Main Category: Pregnancy / Obstetrics
Also Included In: Menopause;  Women's Health / Gynecology
Article Date: 15 Dec 2011 - 2:00 PST

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Women with a short cervix should be treated with vaginal progesterone to prevent preterm birth, according to a landmark study by leading obstetricians around the world. Vaginal progesterone decreased the rate of preterm birth by 42%, and significantly reduced the rate of respiratory distress syndrome and the need for mechanical ventilation, as well as a composite of several complications of premature newborns (e.g. infection, necrotizing enterocolitis, intracranial hemorrhage, etc.). An early online version of the study was published today in the American Journal of Obstetrics and Gynecology (AJOG), and is available on the AJOG website free of charge.

"Our analysis provides compelling evidence that vaginal progesterone prevents preterm birth and reduces neonatal morbidity/mortality in women with a short cervix," said lead investigator Dr. Roberto Romero, Chief of the Perinatology Research Branch and Head of the Program in Perinatal Research and Obstetrics of the Division of Intramural Research for the NICHD/NIH/DHHS, Bethesda, MD and Detroit, MI. "Importantly, progesterone reduced early preterm birth (those occurring before 33 or 28 weeks of gestation). These immature babies are at the greatest risk for complications, death, and long-term disability (e.g. cerebral palsy). Progesterone also decreased a fraction of 'late preterm births,' which are the most common preterm deliveries. The profile of adverse events was no different from placebo.

Follow-up studies of babies exposed to progesterone in utero to the age of 18 or 24 months showed no evidence of any behavioral or physical problems. The authors of this study recommend that transvaginal sonographic measurement of the cervix be performed in all pregnant women between 19 to 24 weeks of gestation to assess the risk of preterm delivery. This strategy also allows the identification of women at risk for preterm delivery during their first pregnancy. Other strategies, which are based on treating women with a previous preterm birth, do not address the challenge of prevention in women with their first pregnancy."

Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Moreover, preterm birth is also the main cause of infant mortality (death to the age of one year). Approximately 12.9 million births worldwide are preterm, of which 92.3% occur in Africa, Asia, Latin America, and the Caribbean. In the United States and Europe, there are 1,000,000 preterm births per year.

Progesterone is a natural hormone produced by the ovary during the menstrual cycle and in early pregnancy, and subsequently, in the placenta. A decline in progesterone action is considered to be important for the onset of labor. If such a decline occurs in the mid-trimester, cervical shortening may lead to the onset of preterm labor. The administration of progesterone is postulated to work by maintaining a high concentration of the hormone in the uterine cervix.

Several studies had evaluated the administration of vaginal progesterone versus placebo to prevent preterm birth when a short cervix was found by ultrasound in the mid-trimester of pregnancy. What is unique about the study published today is that investigators worldwide pooled the data from the different studies and performed a meta-analysis of individual patient data (IPD). This is the "gold standard" for summarizing evidence across clinical trials. It has the advantage of increasing the power to detect differences in efficacy and adverse events, and also allows subgroup analyses that may not have been possible in each individual study.

The IPD meta-analysis included five high-quality trials of vaginal progesterone versus placebo, was conducted at multiple centers in both developed and developing countries, and included a total of 775 women and 927 infants. The primary endpoints were: 1) preterm birth at <33 weeks; and 2) a composite index of perinatal morbidity and mortality. The authors also studied other secondary endpoints and explored the effect of cervical length, a history of previous preterm birth, maternal age, race/ethnicity, and body mass index on progesterone action.

The results were remarkably consistent and significant across trials performed in different parts of the world. Administering vaginal progesterone to asymptomatic women with a short cervix revealed by sonogram in the mid-trimester was associated with a 42% reduction in the rate of preterm birth before 33 weeks of gestation. There was also a significant reduction in the risk of preterm birth before 35, 34, and 28 weeks.

The study also found a 43% decrease in neonatal morbidity and mortality. Vaginal progesterone significantly reduced the risk of respiratory distress syndrome by 52%, and there was significantly lower admission to NICUs (placebo, 20.7% vs. progesterone, 29.1%).

Results of previous trials about the effects of vaginal progesterone or injectable progestins (synthetic compounds with progesterone action) in women with a twin gestation had been negative. However, a subset of patients in the study published today focused on women with a twin gestation and a short cervix. In this particular group, vaginal progesterone reduced the rate of preterm birth at <33 weeks by 30% and significantly reduced the composite neonatal morbidity/mortality of twins. Dr. Romero indicated that a study of vaginal progesterone in twin pregnancies with a short cervix is urgently needed to confirm these findings because the reduction in preterm birth did not reach significance (most likely due to the small number of twins available to study).

A major finding of this study is that progesterone benefits not only women who have a short cervix, but also those who have a prior preterm birth and a short cervix. This has practical implications, because vaginal progesterone is a less expensive and less invasive alternative than the placement of a cervical suture (cerclage) in patients who had a previous preterm birth and have a short cervix.

"The results of this analysis of five large randomized trials have the potential to result in a sea change in obstetrical practice in the U.S. and Europe and eventually in the rest of the world," commented AJOG Co-Editor-in-Chief, Thomas J. Garite, MD. "Prematurity is the leading cause of death and damage for newly born babies and despite enormous efforts, no impact has been made in the rate of preterm birth, which is actually rising in recent years."

As advocated in an accompanying editorial by C. Andrew Combs, MD, PhD, Obstetrix Medical Group, San Jose, CA, in the print version of the Journal, the potential for reducing prematurity lies in implementing routine vaginal ultrasound for all pregnant women in the middle months of pregnancy to measure the length of the cervix and if a short cervix is found, treat these patients with progesterone. The majority of premature births occur in women with no risk factors, so this approach has real potential to make an impact in the overall premature birth rate. Two recently published cost analysis studies, suggest that this approach can not only save lives and prevent the devastating damages often caused by prematurity, but can also result in a annual savings of nearly 1/2 billion dollars in health care costs in the U.S. alone.

Article adapted by Medical News Today from original press release. Source: Elsevier
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Childhood Cancer Survivors' Exposure To Chemotherapy, Radiation Does Not Increase Risk Of Birth Defects In Their Children

Main Category: Pediatrics / Children's Health
Also Included In: Cancer / Oncology
Article Date: 13 Dec 2011 - 1:00 PST

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A large, retrospective study shows that children of childhood cancer survivors who received prior treatment involving radiation to testes or ovaries and/or chemotherapy with alkylating agents do not have an increased risk for birth defects compared to children of survivors who did not have such cancer treatment. The findings provide reassurance that increased risks of birth defects are unlikely for cancer survivors who are concerned about the potential effects of their treatment on their children, and can help guide family planning choices.

"We hope this study will become part of the arsenal of information used by the physicians of childhood cancer survivors if reproductive worries arise," said lead author Lisa Signorello, Sc.D., associate professor of medicine at Vanderbilt University in Nashville, TN, and senior epidemiologist at the International Epidemiology Institute in Rockville, MD.

"Childhood cancer survivors face real reproductive concerns, including unknowns related to the effects of therapy. But, hopefully this study will provide some reassurance that their children are unlikely to be at increased risk for genetic defects stemming from their earlier treatment."

According to Signorello, childhood cancer patients frequently receive aggressive, though life-saving, radiation and chemotherapy treatments that can affect their ability to have children. For girls, radiation to the pelvis and the resulting damage to the uterus has been associated with a risk for pregnancy outcomes such as miscarriage and preterm birth, and effects on the ovaries can lead to infertility. Radiotherapy and chemotherapy with alkylating agents (e.g., busulphan, cyclophosphamide and dacarbazine) are DNA-damaging treatments, affecting both cancer and healthy cells. Studies to date have not adequately addressed the question of whether genetic damage from a parent's treatment could be passed down to their offspring. Genetic-based birth defects are rare in the general population (about 3 percent), and while previous research results indicated little or no increased risk for birth defects among the offspring of cancer survivors, such studies were relatively small in size and lacked detailed information about radiation and chemotherapy treatments, such as specific radiation doses to the testes and ovaries.

In the current study, investigators used information from the Childhood Cancer Survivor Study, a large retrospective study of treatment and outcomes in more than 20,000 childhood cancer survivors diagnosed between 1970 and 1986. Signorello and her colleagues examined data from 4,699 children of 1,128 men and 1,627 women who were 5-year childhood cancer survivors. The survivors reported their children's health problems through questionnaires, and investigators also examined medical records from survivors and their children, focusing on survivors' history of radiation to the testes or ovaries and chemotherapy with alkylating agents.

Of the survivors, 63 percent (1,736) had received radiation for their cancer as children, and 44 percent of men (496) and 50 percent of women (810) had received chemotherapy with alkylating agents. Overall, 2.7 percent (129) of the survivors' children had at least one birth defect, such as Down syndrome, achondroplasia or cleft lip. Researchers found that 3 percent of children of mothers exposed to radiation or treated with alkylating chemotherapy agents had a genetic birth defect, compared to 3.5 percent of children of mothers who were cancer survivors but did not have such exposures. Only 1.9 percent of children of male cancer survivors who received these DNA-damaging treatments had such birth defects, compared to 1.7 percent of children of male survivors who did not have this type of chemotherapy or radiation. The researchers concluded that children of cancer survivors were not at higher risk for birth defects stemming from parents' exposure to chemotherapy and/or radiation.

The researchers also noted that a strength of their study is the comparison they made to the children of other cancer survivors and not to the children of people randomly sampled from the general population. Signorello said that comparing cancer survivors to individuals in the general population can be difficult because the latter may not be as thorough in reporting health problems of their children, and the children of cancer survivors may be under heightened clinical surveillance and may appear to have higher rates of birth defects as a result. The investigators did, however, find that the overall prevalence of birth defects among the cancer survivors' children was very similar to what has been reported in the general population.

The study is among the largest to examine birth defects in children of childhood cancer survivors, and among the first to evaluate birth defects using medical records to validate both the children's health problems and the parents' radiation and chemotherapy exposures.

"The possibility of birth defects in offspring has been a lingering concern among cancer survivors because it's hard to address," Signorello said. "We know these are rare outcomes, and a large study group was needed to address these questions. It took years to validate the parents' self-reported outcomes, and to assemble and use the medical records of radiation and chemotherapy treatment exposures to allow us to quantify their exposure doses. These are the strongest results to date, adding greater certainty to other studies examining this common concern among survivors of childhood cancer."

The researchers would like to continue to sequence the DNA of families of childhood cancer survivors (survivors and their children) to see if there is any evidence of radiation- or chemical-induced genetic damage, even if the children did not have birth defects. They would also like to combine data from all U.S. and international studies on this topic in order to provide even larger, more definitive results.

"As the proportion of childhood cancer survivors within our population grows, it is clear that a very large number of former patients will be impacted by the results of this study. Cancer survivors and newly diagnosed patients worry about the effect that chemotherapy and radiation therapy may have on their future children. While we as oncologists have felt the risk of congenital abnormalities to be low, we now have concrete data from a very large number of children to support us in our conversations with survivors and newly diagnosed patients. These results will reassure survivors that their previous cancer therapy does not appear to result in an increased risk of birth defects in their future offspring."

Article adapted by Medical News Today from original press release. Source: American Society of Clinical Oncology
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13 Dec. 2011. APA
American Society of Clinical Oncology. (2011, December 13). "Childhood Cancer Survivors' Exposure To Chemotherapy, Radiation Does Not Increase Risk Of Birth Defects In Their Children." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239068.php.

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