Wednesday October 17, 2018

Drug prescribed to Pregnant Women with history of delivering Premature Babies may do more Harm than Good: Study

The drug, mostly prescribed to pregnant women with a history of delivering premture babies may even increase the risk of developing gestational diabetes

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New York, March 15, 2017: A drug commonly prescribed to pregnant women with a history of delivering premature babies may do more harm than good, says a study.

Far from providing any benefit, this drug — known by the brand name Makena — may even increase the risk of developing gestational diabetes, said the study published online in the American Journal of Obstetrics and Gynecology.

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“Our study showed the drug to be ineffective, and it has a side effect,” said first author of the study David Nelson, Assistant Professor of Obstetrics and Gynecology at University of Texas Southwestern Medical Center (UT Southwestern) in the US.

The drug, a synthetic progestogen hormone called 17-alpha hydroxyprogesterone caproate, was approved by the US Food and Drug Administration (FDA) in 2011 to treat women at risk of delivering a second premature baby.

The FDA gave the drug accelerated approval in part due to findings in a 2003 study published in The New England Journal of Medicine that the drug reduced the likelihood of a repeat preterm delivery.

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However, Makena has been a source of debate among doctors because of the questions raised about the 2003 findings.

Earlier research findings on the benefit of 17-OHPC have been mixed, said Kenneth Leveno, senior author of the study and Professor of Obstetrics and Gynecology at UT Southwestern.

In the newly published study, pregnant women treated at Parkland Memorial Hospital, were offered the drug 17-alpha hydroxyprogesterone caproate (17-OHPC) if they had a prior history of premature births and were carrying a single fetus.

The research took place from 2012 to 2016 and followed 430 women treated with the drug.

Researchers then compared the premature birth rate of those women with the historical premature birth rate of 5,787 patients seen at Parkland between 1988 and 2011 — women who also had a history of premature delivery but never took the drug.

Of the women in the study group who took the drug, 25 per cent had a premature delivery.

That compared with a 16.8 per cent preterm birth rate in the historical nondrug group.

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The rate of gestational diabetes was 13.4 per cent in women treated with the drug, compared with eight per cent in the other group, the study found.

Gestational diabetes often goes away after the birth, and therefore is not usually a serious problem for the mother, Nelson said.

However, it can lead to deliveries of larger babies and increased chances for cesarean sections and other birth complications. (IANS)

 

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C-Section Births Doubles In Number, Reaching Epidemic Proportions: Doctors

C-section is a type of major surgery, which carries risks that require careful consideration

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A newborn, one of 12 babies born by C-section, cries inside an incubator at the Bunda Hospital in Jakarta, Indonesia, Dec. 12, 2012. Several hospitals in Indonesia's main cities performed more cesareans than usual with new mothers hoping a 12-12-12 birth date will bring luck to their newborns. VOA

Worldwide cesarean section use has nearly doubled in two decades and has reached “epidemic” proportions in some countries, doctors warned Friday, highlighting a huge gap in childbirth care between rich and poor mothers.

They said millions of women each year may be putting themselves and their babies at unnecessary risk by undergoing C-sections at rates “that have virtually nothing to do with evidence-based medicine.”

In 2015, the most recent year for which complete data is available, doctors performed 29.7 million C-sections worldwide, or 21 percent of all births. This was up from 16 million in 2000, or 12 percent of all births, according to research published in The Lancet.

It is estimated that the operation, a vital surgical procedure when complications occur during birth, is necessary 10-15 percent of the time.

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The Yusuf Dantsoho Memorial Hospital has a high success rate with C-sections. Kaduna, Nigeria. Photo by Chika Oduah, VOA

Varying country rates

But the research found wildly varying country rates of C-section use, often according to economic status: In at least 15 countries, more than 40 percent births are performed using the practice, often on wealthier women in private facilities.

In Brazil, Egypt and Turkey, more than half of all births are done via C-section.

The Dominican Republic has the highest rate of any nation, with 58.1 percent of all babies delivered using the procedure.

But in close to a quarter of nations surveyed, C-section use is significantly lower than average.

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Maternal death and disability rates are higher after C-section Flickr

Reasons to opt for surgery

Authors pointed out that while the procedure is generally overused in many middle- and high-income settings, women in low-income situations often lack necessary access to what can be a life-saving procedure.

“We would not expect such differences between countries, between women by socioeconomic status or between provinces/states within countries based on obstetric need,” Ties Boerma, professor of public health at the University of Manitoba, Winnipeg, and a lead author on the study, told AFP.

Jane Sandall, professor of social science and women’s health at King’s College London and a study author, told AFP that there were a variety of reasons women were increasingly opting for surgery.

These include “a lack of midwives to prevent and detect problems, loss of medical skills to confidently and competently attend a vaginal delivery, as well as medico-legal issues.”

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It also identified an emerging gap between wealthy and poorer regions within the same country. Flickr

Doctors are often tempted to organize C-sections to ease the flow of patients through a maternity clinic, and medical professionals are generally less vulnerable to legal action if they choose an operation over a natural birth.

Sandall also said there were often “financial incentives for both doctor and hospital” to perform the procedure.

The study warned that in many settings young doctors were becoming “experts” in C-section while losing confidence in their abilities when it comes to natural birth.

Income a factor

It also identified an emerging gap between wealthy and poorer regions within the same country. In China, C-section rates diverged from 4 percent to 62 percent; in India the range was 7-49 percent.

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Worldwide, more than 11 percent of babies are born premature. Pixabay

While the U.S. saw more than a quarter of all births performed by C-section, some states used the procedure more than twice as often as others.

“It is clear that poor countries have low C-section use because access to services is a problem,” Sandall said. “In many of those countries, however, richer women who live in urban areas, have access to private facilities have much higher C-section use.”

Risks to mother, child

C-sections may be marketed by clinics as the “easy” way to give birth, but they are not without risks.

Maternal death and disability rates are higher after C-section than vaginal birth. The procedure scars the womb, which can lead to bleeding, ectopic pregnancies (where the embryo is stuck in the ovaries), as well as still- and premature future births.

 

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Doctors are often tempted to organize C-sections to ease the flow of patients through a maternity clinic. Flickr

 

The authors suggested better education, more midwifery-led care and improved labor planning as ways of ensuring C-sections are only performed when medically necessary, as well as ensuring women properly understand the risks involved with the procedure.

“C-section is a type of major surgery, which carries risks that require careful consideration,” Sandall said.

Also Read: Novel Blood Test May Predict Autism Risk In Babies During Pregnancy

In a comment accompanying the study, Gerard Visser of the University Medical Centre in the Netherlands, called the rise in C-sections “alarming.”

“The medical profession on its own cannot reverse this trend,” he said. “Joint actions are urgently needed to stop unnecessary C-sections and enable women and families to be confident of receiving the most appropriate care for their circumstances.”