Previously, ACOG had recommended a comprehensive postpartum visit occur within the first 6 weeks after birth.
Results in the 202B and 202C trials showed that brexanolone achieved the primary endpoint of mean reduction from baseline in the Hamilton Rating Scale for Depression.
The test detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor.
To assess safety and efficacy of artemisinin-based combination therapies (ACTs) during pregnancy, researchers from the CDC conducted an analysis of the literature which included clinical trials, observational studies, meta-analyses and case reports conducted in Asia and Africa.
The new Essure labeling restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device.
Bonjesta is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief.
Bremelanotide is used as needed prior to anticipated sexual activity.
Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.
At the 43-month endpoint, a total of 60.7% (307/506) of the abaloparatide followed by alendronate group had ≥3% increase in bone mass at all 3 sites (P<0.0001) vs. 24% (121/505) of the placebo followed by alendronate group.
Results - measured by the alkaline hematin method - found that at 6 months those in the combination group had 76.2% (P<0.001) clinical response compared to the elagloix along group, in which only 10.1% had a clinical response.
TX-001HR is an investigational treatment for moderate-to-severe vasomotor symptoms due to menopause.
The recall was initiated due to a manufacturing defect.
Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.
Makena was the first FDA-approved treatment option for pregnant women who have had prior spontaneous preterm birth.
Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
ADHD medication prescriptions are increasingly common among privately insured, reproductive-aged women.
A 2011 committee opinion from the American College of Obstetricians and Gynecologists (ACOG) recommended that sulfonamides and nitrofurantoin may be prescribed in the first trimester of pregnancy only when other antimicrobial therapies are deemed clinically inappropriate.
Balcoltra is the only branded contraceptive that combines levonorgestrel 0.1mg and ethinyl estradiol 20mcg with ferrous bisglycinate 36.5mg.
The drug-free supplements also contain varying levels of flax, vitamin B2, vitamin B6, D-biotin, and vitamin D3.
The law, enacted in 2013 and implemented in 2016, allows pharmacists to prescribe birth control to increase access to oral contraceptives, patches, rings, and injections for women.
The Lia Pregnancy Test is made with the same plant based fibers as most toilet paper and weighs less than 6 squares of the leading 3-ply toilet paper.
GONAL-f (follitropin alfa injection) is a recombinant human follicle-stimulating hormone (r-hFSH) approved for the treatment female infertility and a rare form of male infertility.
The data showed women who used IUD had a lower occurrence of cervical cancer (odds ratio [OR] 0.64, 95% CI: 0.53-0.77).
No new safety concerns were identified with elagolix use for the 12-month treatment period
Results showed that 22.2% and 73.7% experienced shivering postoperative in the acetaminophen and placebo groups, respectively.
The researchers found that ever being breastfed was associated with a lower risk of CD and UC (OR 0.71, 95% CI 0.59-0.85 and OR 0.78, 95% CI 0.67-0.91 respectively).
The recommendations will be published in the November issue of the American Journal of Obstetrics and Gynecology.
A total of 703 abortion facilities in the U.S. and 94 in Canada were surveyed to estimate the prevalence of medication abortion practices and to compare the regional differences.
The device is intended to enhance the accuracy of laparoscopic instruments in manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery.
Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.
The updates include a primer on HCV resistance and guidance on treating patients who have undergone kidney transplantation.
Noven announced that CombiPatch (estradiol/norethindrone acetate transdermal system) and Minivelle (estradiol transdermal system) are now readily available following a temporary product shortage.
The majority of syphilis infections are seen particularly in gay, bisexual, and other men who have sex with men (MSM), of which half are also diagnosed with HIV.
"Scientifically, it is unclear why this would occur," states Mr. Brown. "In the same study, when vaccination was given either later in the first trimester or in the second or third trimester, there was no association seen with pregnancy loss or any other adverse pregnancy outcomes."
The data indicated little association between vaccination in females (FR 0.98, 95% CI: 0.90, 1.08) or males (FR 1.07, 95% CI: 0.79, 1.46) and fecundability.
The approval was based on two randomized, placebo-controlled studies which evaluated the efficacy of Solosec in the treatment of bacterial vaginosis.
In addition, the researchers assayed umbilical cord blood samples from 33 infants to assess the concentration of biologic agents.
Overall, the study points to an association between spontaneous abortion and influenza vaccination receipt in the past 28 days. This link, however, proved significant only among those vaccinated in the previous season with the pH1N1-containing vaccine.
Researchers found a "surprisingly limited number of prospective studies" specifically addressing the question of whether consuming small amounts of alcohol has an impact on pregnancy and childhood outcomes.
Patients were randomized (1:1) to receive immediate device insertion postpartum (n=132) or delayed device insertion (n=127), which occurred 4-12 weeks postpartum
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.
Laboratory test results have indicated a lower than expected potency affecting certain lots which would lead to a lower dose being administered.
The study authors reported that of the 11,932 infants exposed to HIV, 5780 (48.4%) of them were considered ART exposed from conception.
More women are looking toward alternatives like licorice due to, "concerns about the risk of stroke and breast cancer associated with conventional hormone," said Richard B. van Breemen, PhD, and lead author.
Premenstrual exacerbation (PME) of depression has been found to occur in roughly two-thirds of women with depressive disorders.
The data showed women with an intact uterus did not have a significantly different risk of stroke, invasive breast cancer, colorectal cancer, endometrial cancer, and pulmonary embolism/deep vein thrombosis (PE/DVT) between those who used vaginal estrogen and those who did not.
Women with epilepsy were at increased risk of adverse pregnancy and delivery outcomes.
The concomitant use of HCV drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to the potential for liver enzyme elevations.
Delayed-release DMF exerts anti-inflammatory and neuroprotective properties for the treatment of relapsing multiple sclerosis, a disease that often develops in women between the ages of 20 and 40.
The FDA's approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from the ongoing Phase 3 ACCESS IUS trial.
Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens (with minimal systemic exposure) to help restore vaginal tissue.
Commenting on the report, retired Ob-Gyn Valerie Anne Jones, MD said, "Access to maternity care and women's health services is vitally important, and we need to have infrastructure to support the numbers or these women will have no Ob-Gyn to turn to despite having insurance."
The data showed in utero exposure to clindamycin was associated with a higher risk of MCMs (adjusted odds ratio [aOR] 1.34, 95% CI: 1.02-1.77), musculoskeletal system malformations (aOR 1.67, 95% CI: 1.12-2.48), and ventricular/atrial septal defect (aOR 1.81, 95% CI: 1.04-3.16).
Gonorrhea is a sexually transmitted infection (STI) that can affect the genitals, rectum, and throat. Complications include pelvic inflammatory disease, ectopic pregnancy, infertility, and an increased risk of HIV.
While the clinicians could not rule out the possibility of transmission from a colonized household member, their final diagnosis was late-onset GBS disease attributable to high maternal colonization secondary to consumption of GBS-infected placental tissue.
In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.
The patient was a 32-year-old nulliparous white female who reported a 5-year history of severe hypertension, hypokalemia, and resultant systolic dysfunction.
Firstly, NAMS reiterates that HT should be individualized for each patient and requires periodic reevaluation for risks and benefits of selected therapy.
Cervical cap insemination has demonstrated a pregnancy success rate of up to 20%.
The study included information on 1,325,563 women enrolled in Medicaid. They gave birth between 2000 and 2010.
The analysis found that the simulated maternal serum concentration associated with the lowest probability of infant cerebral palsy was 4.1mg/dL, while the simulated total administered magnesium dose associated with the lowest probability of delivering an infant with cerebral palsy was 64g.
The data showed sarcopenia was 4 times more prevalent for the high-risk alcohol drinking group vs. the low-risk alcohol drinking group (odds ratio 4.29, 95% CI: 1.87, 9.82).
A review of recent data showed that insemination with sperm from an HIV-negative donor is the safest option for a discordant couple where the woman does not have HIV but the man is HIV-positive.
While IUD displacement has been discussed in the literature, the authors could not find a similar case which showed a displaced IUD reaching the diaphragm and causing chest pain.
Mibelas 24 Fe is an oral contraceptive indicated to prevent pregnancy in women who choose to use oral contraceptives.
The study was conducted in 1,000 women residing in the Republic of Ireland and Northern Ireland, where abortion is not available through the formal healthcare system.
The investigators found that earlier menopause was associated with increased risk of heart failure, and this link was stronger in women who had natural rather than surgical menopause.
Replens contains a blend of moisturizers and vitamins that help soothe and relieve symptoms such as irritation, discomfort, and chafing.
All 16 infants in the clinical trial of the device demonstrated a successful joining of their esophagus within 3-10 days after receiving it.
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
In general, an increased risk of spontaneous abortion was seen with the use of macrolides (except erythromycin), quinolones, tetracyclines, sulfonamides, and metronidazole during early pregnancy.
Five lamb fetuses of 105 to 108 days of gestation were run for 25-28 days, and three fetuses of 115 to 120 days of gestation were run for 20-28 days.
Autism spectrum disorder was diagnosed by age 15 in 5.28% of exposed vs. 2.14% of unexposed babies; 12.63% of exposed vs. 5.46% of unexposed babies were diagnosed with ADHD by age 15.
The researchers found the associations of hot flashes to be independent of other cardiovascular disease risk factors.
"The findings highlight the likelihood that prenatal exposure to progesterone may have a long-term influence on behavior related to sexuality in humans," said lead researcher June Reinisch, Director Emerita of The Kinsey Institute.
TherapeuticsMD announced positive data for its investigational hormone therapy, TX-001HR, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Study findings were presented at the annual meeting of the Endocrine Society, ENDO 2017.
Information on vaccination, adverse pregnancy outcomes, and potential confounders were assessed for links in a cohort of women in Denmark.
What makes the technology ground-breaking is how it creates a dynamic culture in which organs communicate with each other as opposed to being static in a dish.
The researchers found that the overall survival was strongest among premenopausal women in the highest 25OHD tertile group.
Hypothalamic amenorrhea occurs when the hypothalamus slows or stops releasing GnRH, a hormone that controls the menstrual cycle. It can increase the risk of other health issues such as delayed puberty in adolescents and infertility in female adults.
The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Solosec (secnidazole oral granules; Symbiomix) for the treatment of bacterial vaginosis (BV).
Sales of prenatal supplements with DHA continue to rise, however little evidence exists on whether supplementation imparts a benefit on offspring neurodevelopment.
Researchers stated that there is a need for improved contraceptive access for teens, as proven by the increase in use of hormonal emergency contraceptives after the FDA approved the OTC availability under Plan B in 2012.
Embolization for uterine fibroids may be underused in U.S. hospitals, compared with surgery, according to research presented at the annual meeting of the Society of Interventional Radiology, held from March April 4 to 9 in Washington, D.C.
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
Findings from a new study published in the journal Pharmacoepidemiology and Drug Safety indicate an increase in ondansetron use for the management of nausea among pregnant women from <1% in 2001 to 22.2% in 2014
Researchers found that their evidence showed no protective association between postmenopausal HT use and AD or dementia, although they observed a reduced AD risk among those with long-term self-reported HT use.
The investigators found that overall survival of periviable infants rose from 30% at the start of the research to 36% in the last time period
Even though Zika virus was found to linger for 3 months in semen, scientists say recommendations urging abstinence, condoms for 6 months after infection should still be followed.
The FDA have approved Tirosint-SOL, a liquid form of levothyroxine; a synthetic form of the thyroid hormone thyroxine.
A study published in the American Journal of Obstetrics & Gynecology reports that the total length of induced labor may be reduced with the use of glucose supplementation.
Chronic pain patients being treated with certain opioid and non-opioid medications had significantly lower serum concentrations of free testosterone (fTe) and free estradiol (fE2), highlighting the potential endocrinologic side effects of these drugs. These were the findings of a new study published in the journal Drug Testing and Analysis.
A fecal microbiota transplant through colonoscopy appears to be safe for recurrent Clostridium difficile infection during pregnancy, according to a case report published in the March issue of Obstetrics and Gynecology.
Prenatal exposure to bisphenol A (BPA) may raise a child's risk of obesity by altering hypothalamic circuits that regulate feeding behavior and energy balance, according to an experimental study published online Feb. 7 in Endocrinology.
In a study of female patients with epilepsy, retrospective data found that unintended pregnancy was common and varied by contraceptive type and antiepileptic drug (AED) stratification. Full findings are published in Neurology.
According to a new study published in The Journal of Clinical Endocrinology & Metabolism, preconception-initiated low-dose aspirin may help prevent pregnancy loss in women with high levels of C-reactive protein (CRP) who have previously lost a pregnancy.
Endoscopy during pregnancy is associated with increased risk of preterm birth or small for gestational age, according to a study published in the February issue of Gastroenterology.
The Food and Drug Administration has approved the marketing of the Seeker System (Baebies, Inc.) for the screening of four rare lysosomal storage disorders (LSDs) in newborns.
From 2002 to 2012 there was an increase in herb and supplement use among pregnant women, according to a research letter published in the American Journal of Obstetrics and Gynecology.
Licorice consumption during pregnancy has been linked to lower IQ, poorer memory, and attention deficit hyperactivity disorder (ADHD)-type problems in offspring.