Pregnancy and Birth

Amid the media frenzy regarding KV Pharmaceutical's decision to sell the FDA-approved drug Makena (hydroxyprogesterone caproate injection) at up to $1500 per injection, the pharmaceutical company as well as the FDA took steps last week to ensure that the medication, which is recommended for women at high risk for premature birth, is more accessible to patients.

Group B streptococci (GBS) is still the dominant cause of neonatal bacterial meningitis, whereas Escherichia coli (E. coli) is the most common cause among preterm infants, according to a study published in the March issue of The Pediatric Infectious Disease Journal.

The use of progestin-estrogen oral contraceptive pills (OCPs) in women prior to becoming pregnant does not appear to increase the risk of adverse respiratory outcomes in offspring, according to a study presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology, held from March 18 to 22 in San Francisco.

There's an important subtext that undergirds defensive medicine that often goes unrecognized and therefore unanalyzed. Defensive medicine is driven by the fact that we live in a "risk society," a society that is organized around a new understanding of risk.

A 43 year old woman came to me with irregular bleeding despite being on birth control pills. Her OB/GYN had inserted a Mirena® IUD 7 months ago, which failed to stop her irregular bleeding.

Obesity is a worldwide public health concern that affects many pregnant women. According to new research published in British Journal of Obstetrics and Gynaecology, pregnancy is an ideal time to initiate healthy weight and lifestyle discussions with patients.

Answering the Institute of Medicine’s call to improve patient safety, the New York Presbyterian Hospital-Weill Cornell Medical Center undertook a step-wise, comprehensive, and ongoing safety program. The program was conceived in 2002 and began with a review by independent consultants.

Prophylactic treatment with 17-alpha-hydroxyprogesterone caproate (17Pc) in twin pregnancy does not reduce neonatal morbidity or prolong gestation, according to a study published in the March issue of the American Journal of Obstetrics & Gynecology.

Between 1965 and 2007, the prevalence of high-intensity smoking declined in California and in the remaining states, according to a study published in the March 16 issue of the Journal of the American Medical Association.

Higher serum polychlorinated biphenyl (PCB) concentration levels that are within the normal range for women in the general U.S. population are associated with failed implantation in women undergoing in vitro fertilization (IVF), according to a study published online Feb. 24 in Environmental Health Perspectives.

Low-level lead exposure, measured by umbilical blood lead levels, suggests a significant association with elevations in maternal blood pressure during labor and delivery, according to a study published online Feb. 3 in Environmental Health Perspectives.

The incidence and severity of cerebral palsy (CP) among preterm survivors decreased significantly from 1990 to 1993 onward, possibly because of a reduction in severe cystic periventricular leukomalacia (c-PVL), according to a study published online March 3 in The Journal of Pediatrics.

A recent article in the Wall Street Journal describes some of the ways health care professionals are collaborating to improve obstetrics care, thanks in part to grants from the federal Agency for Healthcare Research and Quality.

The 2009 H1N1 pandemic caused anxiety and concern, especially for pregnant women and their physicians. The Centers for Disease Control (CDC) recognized this special patient population and the increased risk for serious problems and negative outcomes-both for the women and their unborn babies. As such, the CDC advised doctors to provide antiviral medicines to those with symptoms of the flu and vaccines to those pregnant women who were eligible. They further partnered with the American College of Obstetricians and Gynecology, the American Medical Association, and the American Academy of Family Physicians to educate clinicians and urge their participation in the 2009 H1N1 vaccination programs.

Maternal use of opioid analgesics just prior to or during early pregnancy is associated with a modestly higher risk of certain birth defects, according to a study published online Feb. 24 in the American Journal of Obstetrics & Gynecology.

Postmenopausal women who used to smoke or who currently smoke appear to be at a higher risk of invasive breast cancer than postmenopausal women who never smoked, according to a study published online March 1 in BMJ.

The U.S. Food and Drug Administration has notified health care providers and consumers that new data indicate that women who take topiramate (Topamax) during pregnancy increase the risk for cleft lip and cleft palate in their offspring.

Women who smoke cigarettes during the first trimester of pregnancy may increase their offspring's risk for congenital heart defects (CHDs), according to research published online Feb. 28 in Pediatrics.

When used properly, oral contraceptives are extremely effective in preventing unintended pregnancies, yielding only 3 pregnancies per 1000 users in the first year of use. In reality, however, women may not be as adherent as necessary to obtain this ideal rate-studies have shown that about 50% of women regularly miss at least 1 pill per cycle.

News of KV Pharmaceutical’s plan to sell Makena (hydroxyprogesterone caproate injection) at up to $1500 per injection is receiving some serious backlash. The drug-perhaps best known to physicians as 17P-has been used for years to prevent preterm deliveries. Before Makena’s FDA approval last month, 17P had an “orphan drug” designation; forms of the medication were custom-compounded in pharmacies, which were then provided to patients at a cost of around $10.

Makena (hydroxyprogesterone caproate) has been approved by the U.S. Food and Drug Administration to help prevent birth before 37 weeks of pregnancy in women who have had at least one prior early delivery.

The American Heart Association (AHA) has compiled a series of evidence-based recommendations for the diagnosis, management, and treatment of cerebral venous thrombosis (CVT), and specifically for its management during pregnancy and postpartum, detailed in a statement published online Feb. 3 in Stroke.

The U.S. teenage birth rate has resumed its decline, reaching a historic low in 2009, according to a report published in the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics (NCHS) February Data Brief.

Sex during pregnancy is generally safe, and abstinence should be recommended only for women at risk of preterm labor or antepartum hemorrhage due to placenta previa, according to a primer published online Jan. 31 in CMAJ, the journal of the Canadian Medical Association.

Overnight closed-loop insulin delivery appears to be safe among pregnant women, according to a study published in the February issue of Diabetes Care.

Is there a way to predict which patients will have the best outcomes following an assisted reproductive intervention? Dr William Gibbons, director of the Family Fertility Program at Texas Children’s Hospital and professor of obstetrics and gynecology at Baylor College of Medicine, and colleagues examined birth weight and gestational age of singleton pregnancies from in vitro fertilization, donor egg, and gestational carrier cycles to determine which factors most influence outcomes.

Progesterone support during the luteal phase is needed to allow for implementation in medically assisted cycles. To date, available options have not met all of the ideals of the “perfect” progesterone strategy-easy to administer, safe with minimal adverse effects, and effective in producing pregnancies.

The fertility field has seen incredible successes with in vitro fertilization and intracytoplasmic sperm injection. However, the resulting successes have yielded concern over the high rates of multiple pregnancies, which can result in increased maternal and perinatal morbidity and mortality as well as increased health care utilization and costs.

One serum blood test is sufficient to diagnose hyperprolactinemia, and dynamic testing of prolactin secretion should be avoided, according to new guidelines published in the February issue of the Journal of Clinical Endocrinology & Metabolism.

Injectable terbutaline should not be used for prevention or prolonged treatment of preterm labor in pregnant women because of the potential for serious maternal heart problems and death, according to a warning issued by the U.S. Food and Drug Administration. The agency also warned that oral terbutaline should not be used for prevention or any treatment of preterm labor because of similar safety concerns and the fact that it has not been shown to be effective.