ACOG: Revised Committee Opinion on Postpartum Care Released

Previously, ACOG had recommended a comprehensive postpartum visit occur within the first 6 weeks after birth.

NDA Submitted for Postpartum Depression Treatment Brexanolone

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.

Point-of-Care Test for Assessing Risk of Spontaneous Preterm Birth Approved

The test detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor.

CDC Recommends Additional Malaria Tx Option During Pregnancy

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.

FDA Puts New Restrictions on Permanent Birth Control Implant Essure

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 Now Available to Treat Nausea and Vomiting of Pregnancy

Bonjesta is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief.

Bremelanotide NDA Submitted to FDA for Hypoactive Sexual Desire Disorder

Bremelanotide is used as needed prior to anticipated sexual activity.

Cimzia Label Update Provides New Information for Women of Childbearing Age

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.

Abaloparatide Followed by Alendronate Ups BMD in Postmenopausal Women

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.

Positive Results for Elagolix in Second Phase 3 Uterine Fibroid Trial

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.

FDA Accepts NDA for Bio-Identical Combination Hormone Therapy

TX-001HR is an investigational treatment for moderate-to-severe vasomotor symptoms due to menopause.

Product Defect Leads to Recall of Hormone Replacement Therapy

The recall was initiated due to a manufacturing defect.

Progestin-Only Contraceptives and Depression: Is There a Link?

Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.

Ready-to-Use Makena Formulation Approved to Reduce Preterm Birth Risk

Makena was the first FDA-approved treatment option for pregnant women who have had prior spontaneous preterm birth.

Edurant Dosing Recommendations Updated for Pregnant HIV Patients

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

ADHD Medication Use Increasing Among Reproductive-Aged Women

ADHD medication prescriptions are increasingly common among privately insured, reproductive-aged women.

Nitrofurantoin, TMP-SMX Often Prescribed in Early Pregnancy for UTI

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.

Oral Contraceptive Balcoltra Gets FDA Approval

Balcoltra is the only branded contraceptive that combines levonorgestrel 0.1mg and ethinyl estradiol 20mcg with ferrous bisglycinate 36.5mg.

Drug-Free Supplements Launched for Menopause Symptom Relief

The drug-free supplements also contain varying levels of flax, vitamin B2, vitamin B6, D-biotin, and vitamin D3.

Few CA Pharmacies Offer RPh-Prescribed Contraception, Despite Law

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.

First Flushable Pregnancy Test Cleared for OTC Use

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.

FDA Approves New Version of Gonal-f Prefilled Pen

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.

IUD Use and Cervical Cancer Risk: What's the Link?

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).

Long-Term Efficacy Data Show Sustained Pelvic Pain Reduction With Elagolix

No new safety concerns were identified with elagolix use for the 12-month treatment period

Acetaminophen Evaluated for Postoperative Shivering

Results showed that 22.2% and 73.7% experienced shivering postoperative in the acetaminophen and placebo groups, respectively.

Does Breastfeeding Protect Against Future Inflammatory Bowel Conditions?

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).

SMFM Issues Recommendations on Managing Hepatitis C in Pregnancy

The recommendations will be published in the November issue of the American Journal of Obstetrics and Gynecology.

Do U.S. Medication Abortion Practices Follow Evidence-Based Guidelines?

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.

Robotically-Assisted Device Cleared for Surgery Use

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.

First-in-Class Oral Tx for Uterine Fibroids One Step Closer to Approval

Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.

Updated HCV Guidance Focuses on Additional Patient Populations

The updates include a primer on HCV resistance and guidance on treating patients who have undergone kidney transplantation.

CombiPatch, Minivelle Patches No Longer in Shortage

Noven announced that CombiPatch (estradiol/norethindrone acetate transdermal system) and Minivelle (estradiol transdermal system) are now readily available following a temporary product shortage.

CDC: Sexually Transmitted Diseases Hit 'Record High' in U.S.

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.

ACOG Issues Statement on Safety of Flu Vaccine During Pregnancy

"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."

HPV Vaccination May Protect Fertility for Some Women

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.

Single-Dose Oral Therapy for Bacterial Vaginosis Gets Approval

The approval was based on two randomized, placebo-controlled studies which evaluated the efficacy of Solosec in the treatment of bacterial vaginosis.

Does Prenatal Biologic Therapy for IBD Affect Infant Vaccine Response?

In addition, the researchers assayed umbilical cord blood samples from 33 infants to assess the concentration of biologic agents.

Experts Concerned About Study that Links Flu Vaccine to Spontaneous Abortion

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.

Alcohol Consumption and Pregnancy: Is Any Amount Safe?

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.

Does Timing of Postpartum IUD Insertion Impact Breastfeeding 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 NDA Submitted for Treating Endometriosis-Associated Pain

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.

Recall of Oxytocin Products Due to Lower than Expected Potency

Laboratory test results have indicated a lower than expected potency affecting certain lots which would lead to a lower dose being administered.

Adverse Birth Outcomes Examined by Antiretroviral Tx Regimens

The study authors reported that of the 11,932 infants exposed to HIV, 5780 (48.4%) of them were considered ART exposed from conception.

Licorice Supplements May Put Patients at Risk for Drug Interactions

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.

Targeting Premenstrual Breakthrough of Depression with OCs: Is it Effective?

Premenstrual exacerbation (PME) of depression has been found to occur in roughly two-thirds of women with depressive disorders.

Cancer, CV Risks Examined for Vaginal Estrogen Tx in Postmenopausal Women

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.

Does Antiepileptic Drug Use Contribute to Adverse Pregnancy Outcomes?

Women with epilepsy were at increased risk of adverse pregnancy and delivery outcomes.

Contraindication Added to OCs, Other Ethinyl Estradiol-Containing Drugs

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.

Dimethyl Fumarate and Oral Contraceptives: Drug Interactions Explored

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.

Liletta Approved to Prevent Pregnancy for up to Four Years

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.

Novel Treatment for Dyspareunia Due to Menopause Now Available

Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens (with minimal systemic exposure) to help restore vaginal tissue.

Ob-Gyn Shortage Possible in Some Parts of the U.S., Says New Report

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."

Antibiotics During Pregnancy and Birth Defects: What's the Link?

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).

WHO: Resistance to Last-Resort Gonorrhea Tx Seen in 66% of Countries

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.

Maternal Ingestion of Placenta Capsules Linked to Bacteremia in Infant

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.

NDA Resubmitted for Twirla Contraceptive Patch

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.

Severe, Monthly Hypertensive Episodes in a Female Patient

The patient was a 32-year-old nulliparous white female who reported a 5-year history of severe hypertension, hypokalemia, and resultant systolic dysfunction.

NAMS: New Position Statement on Hormone Therapy

Firstly, NAMS reiterates that HT should be individualized for each patient and requires periodic reevaluation for risks and benefits of selected therapy.

The Stork OTC, an FDA-Cleared, At-Home Conception Device

Cervical cap insemination has demonstrated a pregnancy success rate of up to 20%.

Risks Associated with Lithium Use in Pregnancy Reevaluated

The study included information on 1,325,563 women enrolled in Medicaid. They gave birth between 2000 and 2010.

Ideal Magnesium Sulfate Dose ID'd for Fetal Neuroprotection

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.

Higher Alcohol Intake May Up Muscle Loss, Function for Some Women

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).

HIV Prevention Among HIV-Discordant Couples Trying to Conceive

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.

Contraceptive ID'd as Culprit in Patient with Shortness of Breath, Chest Pain

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.

Birth Control Pills Recalled Due to Out of Sequence Tablets

Mibelas 24 Fe is an oral contraceptive indicated to prevent pregnancy in women who choose to use oral contraceptives.

Medical Abortion via Online Telemedicine: Outcomes Explored

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.

Menopausal Age May Correlate With Heart Failure Risk, Incidence

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 Moisture Restore Gel Available for Vaginal Dryness

Replens contains a blend of moisturizers and vitamins that help soothe and relieve symptoms such as irritation, discomfort, and chafing.

First-of-its-Kind Device Cleared to Treat Esophageal Birth Defect

All 16 infants in the clinical trial of the device demonstrated a successful joining of their esophagus within 3-10 days after receiving it.

FDA Issues Complete Response Letter for Dyspareunia Drug

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.

These Antibiotics Were Found to Increase Miscarriage Risk

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.

Artificial 'Womb' Could Potentially Up Survival of Extremely Premature Infants

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.

Does Prenatal Antidepressant Exposure Up Risk of ADHD, Autism?

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.

Early Hot Flashes May Indicate Presence of Comorbidities

The researchers found the associations of hot flashes to be independent of other cardiovascular disease risk factors.

Prenatal Progesterone Exposure May Affect Offspring Sexual Orientation

"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.

Bio-Identical Combo Therapy Promising for Vasomotor Symptoms of Menopause

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.

Is Quadrivalent HPV Vaccine During Pregnancy Safe?

Information on vaccination, adverse pregnancy outcomes, and potential confounders were assessed for links in a cohort of women in Denmark.

Mini Personalized Reproductive System Called 'Revolutionary'

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.

Vit D Levels May Correlate With Overall Survival in Breast CA

The researchers found that the overall survival was strongest among premenopausal women in the highest 25OHD tertile group.

New Guideline on Hypothalamic Amenorrhea Released

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.

Single-Dose Treatment for Bacterial Vaginosis Under Priority Review

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).

Does Prenatal DHA Have an Impact on Offspring IQ?

Sales of prenatal supplements with DHA continue to rise, however little evidence exists on whether supplementation imparts a benefit on offspring neurodevelopment.

New Review Makes the Case for OTC Oral Contraceptives

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.

U.S. Patients Lack Awareness of Less Invasive Options for Fibroids

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.

Study Investigates Transfer of TNFi Therapy to Breast Milk

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.

Ondansetron Use Increasing Among Pregnant Women

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

Hormone Therapy and Alzheimer's Disease: What's the Link?

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.

U.S. Survival Rates Assessed for Periviable Infants

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

How Long Does Zika Virus Stay in the Body?

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.

FDA Approves Liquid Formulation of Levothyroxine

The FDA have approved Tirosint-SOL, a liquid form of levothyroxine; a synthetic form of the thyroid hormone thyroxine.

Can Glucose Supplementation Shorten Labor in Induced Women?

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.

Certain Pain Meds May Have Significant Endocrinologic Effects

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.

Safety, Efficacy of Fecal Transplant for C. difficile During Pregnancy

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.

Exposure to Common Plastic Compound May Increase Offspring Obesity Risk

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.

Contraceptive, AED Choice May Impact Unintended Pregnancy Rate in Epilepsy

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.

Preconception-Initiated Aspirin May Prevent Pregnancy Loss in Certain Women

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.

Adverse Events Assessed With Endoscopy During 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.

FDA Approves Screening System that Detects Metabolic Disorders in Newborns

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.

Herb, Supplement Use Up Among Pregnant Women

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.

Should Licorice Consumption During Pregnancy Be Avoided?

Licorice consumption during pregnancy has been linked to lower IQ, poorer memory, and attention deficit hyperactivity disorder (ADHD)-type problems in offspring.