Thursday, October 24, 2013

ACOG/SMFM: Replace Phrase 'Term Pregnancy' With 4 Categories

Using the general phrase "term pregnancy" to refer to births between 3 weeks before the estimated date of delivery and 2 weeks after does not convey the distinction of health benefits and risks for each week of gestation in that window, according to the nation's obstetricians and gynecologists.
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) wrote a joint opinion published in the November issue of Obstetrics & Gynecology discouraging use of the general label "term pregnancy" and replacing it with these categories:
  • early term: 37 weeks to 38 weeks, 6 days;
  • full term: 39 weeks to 40 weeks, 6 days;
  • late term: 41 weeks to 41 weeks, 6 days; and
  • post-term: 42 weeks and beyond.
"Until recently, doctors believed that babies delivered in this 5-week window had essentially the same good health outcomes," Jeffrey L. Ecker, MD, chair of the college's Committee on Obstetric Practice, said in a news release. "This terminology change makes it clear to both patients and doctors that newborn outcomes are not uniform even after 37 weeks."
The committee noted in the opinion that outcomes are best for delivery at "full term" (39 weeks - 40 weeks, 6 days). ACOG and SMFM are encouraging physicians, researchers, and public health officials to adopt the new terms to improve data collection and reporting and clinical research, as well as provide the highest-quality pregnancy care.
Peter Bernstein, MD, MPH, obstetrician/gynecologist and maternal-fetal medicine specialist at Montefiore Medical Center in New York City, said the committee's recommendations will formalize a push in the medical community in the last few years to stop scheduling elective deliveries before 39 weeks, a practice that had become more common as families and physicians set the dates for convenience.
"Literature has become very clear that babies born at 37 weeks don't do as well as babies born at 38 weeks, and babies born at 38 weeks don't seem to do as well as those born at 39 weeks, so this arbitrary line saying a baby born at 37 weeks is full-term has led to this normalization of deviance," Dr. Bernstein told Medscape Medical News.
He said it is also important to note that babies thought to be 37 weeks may actually be misdated and at even more risk, at a younger stage of gestation.
Although sometimes delivery before 39 weeks is unavoidable, planned deliveries before 39 weeks should occur only when there are significant health risks to a woman and/or the fetus in continuing the pregnancy, Dr. Ecker said in the news release.
That view is reflected in a related committee opinion, published in April. In that statement, the committee emphasized that the risk for adverse outcomes is greater for neonates delivered in the early-term period compared with those delivered at 39 weeks.
Mortality rates are also higher among neonates and infants delivered in the early term compared with full-term births.
For example, a study published in September also found that compared with term infants born from 39 to 41 weeks' gestation, early-term infants born between 37 and 38 weeks' gestation had a 7-fold higher risk for neonatal morbidity and were at greater risk for admission to the neonatal intensive care unit or neonatology service.
Dr. Bernstein said the committee's latest recommendations will add weight to the push against electing to deliver before 39 weeks without a medical reason.
"I think it's a really good thing. This is something that's been gathering steam," he said.
Obstet Gynecol. 2013;122:1139-1140.

Friday, October 18, 2013

Use of Oral Fluconazole during Pregnancy and the Risk of Birth Defects.

Molgaard–Nielsen D et al. – Case reports suggest that long–term, high–dose fluconazole treatment for severe fungal infections during pregnancy causes a pattern of birth defects. It is unclear whether commonly used lower doses increase the risk of specific birth defects. Oral fluconazole was not associated with a significantly increased risk of birth defects overall or of 14 of the 15 specific birth defects of previous concern. Fluconazole exposure may confer an increased risk of tetralogy of Fallot.
Results
  • The majority of fluconazole–exposed pregnancies were in women who received common therapeutic doses of 150 mg (56% of pregnancies) or 300 mg (31%).
  • Oral fluconazole exposure was not associated with an increased risk of birth defects overall (210 birth defects among 7352 fluconazole–exposed pregnancies [prevalence, 2.86%] and 25,159 birth defects among 968,236 unexposed pregnancies [prevalence, 2.60%]; adjusted prevalence odds ratio, 1.06; 95% confidence interval [CI], 0.92 to 1.21).
  • In addition, oral fluconazole exposure was not associated with a significantly increased risk of 14 of 15 types of birth defects previously linked to azole antifungal agents: craniosynostosis, other craniofacial defects, middle–ear defects, cleft palate, cleft lip, limb defects, limb–reduction defects, polydactyly, syndactyly, diaphragmatic hernia, heart defects overall, pulmonary–artery hypoplasia, ventricular septal defects, and hypoplastic left heart.
  • A significantly increased risk of tetralogy of Fallot was observed (7 cases in fluconazole–exposed pregnancies [prevalence, 0.10%] as compared with 287 cases in unexposed pregnancies [prevalence, 0.03%]; adjusted prevalence odds ratio, 3.16; 95% CI, 1.49 to 6.71).
 New England Journal of Medicine, 09/03/2013  Evidence Based Medicine  Clinical Article

Friday, October 11, 2013

First Do No Harm: Guidelines Define a Nonviable Pregnancy

New criteria for the use of ultrasonography to assess prenatal viability, introduced by the Society of Radiologists in Ultrasound, will help ensure obstetricians are not too hasty in determining that an embryo has ceased developing. The guidelines were published as a review article in the October 10 issue of the New England Journal of Medicine.
Detection of serum human chorionic gonadotropin (hCG) concentration and transvaginal ultrasound imaging have enabled ever-earlier detection of pregnancy. However, previous guidelines may allow false-positives, designating an embryo as absent or nonviable when waiting a few days and repeating tests may reveal that it is neither.
The new, more stringent, diagnostic criteria are:
  • "Crown–rump length of ≥7 mm and no heartbeat
  • Mean sac diameter of ≥25 mm and no embryo
  • Absence of embryo with heartbeat ≥2 [weeks] after a scan that showed a gestational sac without a yolk sac
  • Absence of embryo with heartbeat ≥11 days after a scan that showed a gestational sac with a yolk sac."
The report also lists 8 findings that are "suspicious for, but not diagnostic of, pregnancy failure":
  • "Crown–rump length of <7 ad="" beat="" heart="" mm="" no="">
  • Mean sac diameter of 16–24 mm and no embryo
  • Absence of embryo with heartbeat 7–13 days after a scan that showed a gestational sac without a yolk sac
  • Absence of embryo with heartbeat 7–10 days after a scan that showed a gestational sac with a yolk sac
  • Absence of embryo ≥6 wk after last menstrual period
  • Empty amnion (amnion seen adjacent to yolk sac, with no visible embryo)
  • Enlarged yolk sac (>7 mm)
  • Small gestational sac in relation to the size of the embryo (<5 and="" between="" crown="" diameter="" difference="" length.="" mean="" mm="" rump="" sac="">
If a physician sees 1 or more of these findings, they should investigate further but not immediately reach the conclusion that the pregnancy is not viable, the authors say. "Because none of these signs have been extensively studied, they are considered to be suspicious for, though not diagnostic of, failed pregnancy," the authors write.(N Engl J Med. 2013;369:1443-1451.)

Wednesday, October 9, 2013

FDA Contraindicates Migraine Treatments for Pregnant Women

The US Food and Drug Administration (FDA) has announced that the children of mothers who took medications including or related to valproate(Drug information on valproate) sodium during pregnancy show decreased IQ scores, and that these drugs are now contraindicated for pregnant women.



Contraindicated valproate products include valproate sodium (Depacon), divalproex sodium(Drug information on divalproex sodium) (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
While valproate-containing medicines already have a boxed warning for fetal risk, the FDA’s strengthened recommendations are based on the results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs. The IQ difference varied between 8 and 11 points.
Valproate products have several FDA-approved uses, including the prevention of migraine headaches, treatment of epilepsy seizures, and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder). For bipolar disorder and seizures valproate may have value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable.
“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA is working with manufacturers to make changes to the drug labels to reflect the new information and change the pregnancy category for prevention of migraine headaches to category X (the drug’s risks outweigh the drug’s benefits for this use) from category D (the drug’s benefits outweigh the drug’s risks for this use). Valproate products will remain category D for the other two approved indications—epilepsy and manic episodes associated with bipolar disorder.
 http://hcp.obgyn.net/pregnancy-and-birth/content/article/1760982/2141651

Planned Cesarean No Safer Than Vaginal Delivery for Twins

A planned cesarean delivery in twin pregnancy does not increase or decrease risks to the unborn fetuses when compared with a planned vaginal delivery, according to the results of a randomized controlled trial. The study, published in the October 3 issue of the New England Journal of Medicine, shows that among pregnant mothers of twins between 32 weeks 0 days and 38 weeks 6 days of gestation and whose first twin is in the cephalic presentation, choosing to have a planned cesarean delivery does not affect the risks for fetal or neonatal death or serious neonatal morbidity when compared with choosing to deliver the twins vaginally.
"These results do not indicate that all sets of twins should be delivered vaginally." Michael Greene, MD, notes in an accompanying editorial. "Obstetricians exercising their best clinical judgment delivered both twins by cesarean section in nearly 40% of the women assigned to planned vaginal delivery, which undoubtedly contributed to the salutary outcomes," he writes. "However, the results of this study suggest that a plan to deliver appropriately selected sets of twins vaginally is a reasonably safe choice in skilled hands."
"Given the trends in patient demographic characteristics and preferences, the virtual disappearance of vaginal delivery in cases of breech presentation, and the dramatic reduction in instrumented vaginal delivery (and the associated gradual disappearance of the skills necessary to perform these procedures among obstetricians), it seems unlikely that we will see a major change in use of cesarean delivery for twins nationwide," he concludes. 

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