Sunday, June 19, 2016

OB Nest- A novel approach to antenatal care by remote monitoring of low risk pregnancies.

A novel prenatal care model ( OB Nest) optimizes antenatal care and  improves patient satisfaction by leveraging technology and  reducing the number of office visits during pregnancy.

According to the ACOG recommendations the current antenatal care consists of at least 12-14 visits with an obstetrician, with majority being just brief visits to ensure fetal well-being. Researchers in the past have focused on decreasing the number of visits in low risk pregnancies so that resources and time can be diverted towards high risk pregnancies. But this has resulted in less patient satisfaction and was found unsafe for maternal and fetal well-being.

But researchers at Mayo clinic have developed a new prenatal care model called OB-Nest and families are feeling satisfied with it.  The results of using the newly devised program were presented at the 2016 annual meeting of the American College of Obstetricians and Gynecologists (ACOG) by Yvonne S Butler Tobah, MD, who is an instructor in obstetrics-gynecology at the Mayo Clinic, Rochester, Minnesota. The results were also published in the May issue of Journal of Obstetrics and Gynecology.

"Traditionally, pregnancy is treated as a sickness," says Yvonne Butler Tobah, M.D., lead author of this study. "We wanted our care to reflect the normal, life-bringing event that it is, and [we] looked for a way to transform prenatal care into a wellness, patient-oriented experience."

Researchers at Mayo clinic embarked on a randomized, controlled trial enrolling 300 women, all of whom met criteria for low risk pregnancies. The patients were randomized to either OB-Nest (134 patients) or usual antenatal care practice (133 patients) according to ACOG guidelines of standard 12 office visits.  Both the groups received lab testing, imaging, immunizations, and appropriate anticipatory guidance according to ACOG guidelines. 

Patients in the OB Nest group had 8 scheduled office visits and six "virtual care" visits with a lead nurse either via phone or email. They also received home monitoring supplies for measuring blood pressure and fetal heart rate and reporting them online regularly.  They also were a part of online community that included OB Nest participants and nurses from the OB Nest care team.OB Nest Online Communities reinforces the role of OB as supportive and guiding partner in moms’ prenatal experience.

Primary outcomes included patient satisfaction, number of clinic visits, perceived quality of care, and pregnancy-related stress. Secondary outcomes included unplanned visits, fetal and maternal outcomes. Data analysis was performed by intention to treat.

When the results of the trial were compared it was seen that patients in the OB Nest group -- who had remote monitoring -- reported higher satisfaction about their care at 36 weeks (95% versus 77%, respectively, P<0.001). No difference was found in the perceived quality of care by the patients.
OB Nest patients reported 3.4 fewer outpatient scheduled clinic appointments, and 2.85 fewer scheduled appointments with a provider (OBN=9.2 vs UC=11.2, P<.0001) than patients receiving usual care.

No difference was seen in terms of maternal/fetal events, incidence of cesarean delivery, preterm birth, birthweight, or an Apgar score <7. 

However, according to Dr. Tobah the study was did not have sufficient power to detect obstetrical outcome, only patient outcomes. The study also suffered from ascertainment bias as the participants were not blinded. It also has limited generalizability as all the participants were Caucasians and well educated.

Researchers are looking forward to apply OB Nest into larger community settings, with diverse population contributing to larger study population to compare maternal-fetal outcomes and confirm costs savings. They are also looking to apply the study to high-risk population such as patties with Gestational Diabetes Mellitus.

The researchers got the inspiration for the study after a visit to the  Mayo Clinic Center of Excellence, where remote monitoring was being done on patients with end-stage kidney disease. 

ACOG awarded the researchers second prize in the scientific program for 2016.

Both the researchers were employee of Mayo Clinic and received grant for the study.  

References:
http://www.fiercehealthcare.com/it/mayo-clinic-remote-monitoring-low-risk-pregnancies-boosts-patient-satisfaction





Thursday, June 16, 2016

Renal Function Tests useful in predicting the risk of preeclampsia.

Chronic hypertension affects 3-5% of all pregnancies and its prevalence is increasing recently because of rise in number of elderly and obese gravidas. The most prevalent complication in pregnant women with chronic hypertension is the development of preeclampsia.

According to a recent study it is estimated that 17% to 25% of women with chronic hypertension will develop superimposed preeclampsia and these women have worse birth outcomes than women with chronic hypertension without superimposed preeclampsia.

Diagnosing superimposed preeclampsia on chronic hypertension pose a significant challenge because blood pressures are already elevated and proteinuria may be present before pregnancy. There is a continuing search for improved tests to both predict and diagnose preeclampsia.

A recent paper published online June 6 in Obstetrics & Gynecology suggests that baseline renal parameters may be useful in predicting the risk for preeclampsia among pregnant women with chronic hypertension.

This is a retrospective cohort study of 755 women with singleton pregnancy with chronic hypertension. Renal function (urine protein-to-creatinine ratio and serum creatinine) assessment was done in all patients before 20 weeks.

The primary outcome was the development of early onset preeclampsia at less than 34 weeks' gestation; secondary outcomes evaluated were the development of severe preeclampsia at any gestational age, any preeclampsia, small for gestational age, preterm birth at less than 35 weeks' gestation, and composite adverse perinatal outcome including perinatal death, neonatal seizures, assisted ventilation, arterial cord pH lower than 7, and 5-minute Apgar score of 3 or lower.

A Receiver operating characteristic (ROC)curve was created to determine the cut-off for baseline serum creatinine in development of severe preeclampsia.  

It was seen that in these cohort of women, baseline serum creatinine and urine protein-to-creatinine ratio 0.75 mg/dL or greater and 0.12 or greater, respectively, are associated with increased risks of severe preeclampsia before 34 weeks of gestation, severe and mild preeclampsia at any gestational age and for urine protein-to-creatinine ratio, preterm birth at less than 35 weeks of gestation.

These levels are much below what is considered normal.

Further it was seen that 33.3% of women with levels above the arbitrary cut-off developed severe preeclampsia before 34 weeks and remaining 66.7% developed any kind of preeclampsia during pregnancy.

Conversely 97.4% of patients with urine protein-to-creatinine ratio less than 0.12 did not develop severe preeclampsia and 95.4% of patients with baseline serum creatinine less than 0.75 mg/dL did not develop severe preeclampsia.

Patients with UPCR above the cutoff had odds of preterm labor 2.4 times to those with normal levels.

The study results may not be generalized to other populations as it included mostly black women and the blood samples for baseline renal functions were not all collected at the same gestational age, although all were collected before 20 weeks.  The strength was a large study subjects, accurately recorded data and strict study criteria for development of preeclampsia.  

In summary, the study findings suggest that in women with chronic hypertension a creatinine 0.75 mg/dL or greater and a urine protein-to creatinine ratio 0.12 or greater is associated with adverse pregnancy outcomes. These values are much lower than what was previously thought to be normal.

"These findings should be validated in additional studies and, if validated, can be used to counsel women regarding their risk of adverse pregnancy outcomes and to alter surveillance for preeclampsia," the researchers concluded.

References:


Wednesday, June 15, 2016

ACOG updates the recommendations for use of aromatase inhibitors in gynecology practice.

Aroma-tase is a microsomal cytochrome P450 hemoprotein-containing enzyme with a wide expression in different kind of tissues like ovary, testes, endometrium, brain, breast, placenta, skin, bone, and fat. In these tissues it mediates the conversion of androstenedione to estrone and the conversion of testosterone to estradiol in situ. 

Therefore, for tissues which express this enzyme it creates a hyperestrogenic state leading to proliferation of the tissue.

Based on these varied effects aromatase inhibitors are used in treatment of breast cancer, ovulation induction, endometriosis, and other estrogen-modulated conditions.

Currently three aromatase inhibitors are commercially available. Out of which Exemestane is a steroid-derived aromatase inhibitor that binds irreversibly to aromatase and permanently inactivates the available enzyme while Letrozole and anastrozole are reversible inhibitors of aromatase competing with androgens for aromatase binding sites.

The American College of Obstetricians and Gynecologists supports the following recommendations and conclusions: They were published in June issue of Journal of obstetrics and gynecology.

  • For women with breast cancer, bone mineral density screening is recommended with long-term aromatase inhibitor use because of risk of osteoporosis due to estrogen deficiency.
  • Based on long-term adverse effects and safety data, when compared with tamoxifen, aromatase inhibitors are associated with a reduced incidence of thrombosis, endometrial cancer, and vaginal bleeding.
  • For women with polycystic ovary syndrome and a body mass index (BMI) greater than 30, letrozole should be considered as first-line therapy for ovulation induction because of the increased live birth rate compared with clomiphene citrate. Lifestyle changes that result in weight loss should be strongly encouraged.
  • For women with unexplained infertility (regular menstrual cycles, all known male or female factors excluded), a large multicenter study demonstrated that ovulation induction with letrozole resulted in lower live birth rates and multiple gestation rates compared with gonadotropins; however, live birth and multiple gestation rates did not differ significantly between ovulation induction with letrozole compared with clomiphene citrate.
  • Aromatase inhibitors are a promising therapeutic option that may help manage endometriosis-associated pain in combination therapy with progestins.
References: