Wednesday, May 31, 2017

In case you missed it: Here are the top 5 posts this month.

News from ACOG 2017: Changing gloves before abdominal closure brings down the rate of wound infection by almost 50% in Cesarean Section.
Results of a randomized controlled trial presented at the ACOG 2017showed that changing the outer gloves before closing the abdomen decreases the wound complication of infection, cellulitis and dehiscence.

Wound infection after a cesarean section (CS) is a major cause of maternal morbidity, lengthy hospital stays and increased medical cost. The rate of surgical site infection after cesarean section range from 3% to 15%. 

CDC releases ‘long awaited’ guidelines for preventing surgical site infections.
The Center for Disease Control released it’s much awaited update to its 1999 guidelines for the prevention of surgical site infections (SSIs). The guidelines were published online May 3, 2017 in JAMA.
As the number of surgeries performed worldwide rise, so does the human and financial cost of treating this infection also rises as reimbursements for SSIs are often reduced or denied. It is estimated that 50% of SSIs are preventable.

ACOG updates its recommendations for estimating gestational age and due date: May 2017
Accurate gestational dating of pregnancy is very important for optimal maternal and fetal outcome.Throughout pregnancy decisions like ordering and interpreting lab tests, determining fetal growth and performing intervention to prevent preterm births or post-term pregnancies and associated morbidities are based on accurate dating.
Estimated Due Date (EDD)and current gestational dating should be documented on medical records and discussed with the patient as early as possible based on dates of Last Menstrual Period(LMP) and earliest available ultrasound in pregnancy.

ACOG issues guidelines for obstetrics analgesia and anesthesia.
ACOG has issued clinical guidance for obstetricians and other healthcare professional for management of pain during labor and giving anesthesia for any surgical procedure required during labor.
The reviewed guidelines were published in Journal of Obstetrics & Gynecology, April issue.

Antenatal Corticosteroids administration just few hours before preterm delivery improves survival and health gains for the infants.
Imminent preterm labor, with no time to give antenatal corticosteroids? Still give it says the result of a large population based study.
Antenatal corticosteroids given few hours before an imminent delivery is effective in improving survival says results of a large population-based study of 4594 European infants born before 32 weeks’ gestation. This study was published on line today in JAMA Pediatrics.

Vaccinations before, during and after pregnancy.

Prenatal screening

Women who are planning to become pregnant should make sure that they are up to date on their immunizations. This will protect them and the unborn child from many diseases.

The measles, mumps, rubella, and chickenpox (varicella) vaccines are particularly important for women of childbearing age, as these cannot be given when pregnant. If a woman is infected with any of this in pregnancy, particularly first trimester, it results in adverse pregnancy outcome. 

Patients should check with their physician, who can request a blood test to see the blood levels of antibodies against these viruses, because of prior vaccination or prior history of disease itself.

MMR- If you need to get the vaccine for Rubella, avoid getting pregnant for at least a month after receiving the MMR.
Varicella- Similarly, if you are not immune to chickenpox, get vaccinated at least a month before getting pregnant.
HPV Vaccine- The human papillomavirus (HPV) vaccine is recommended for nonpregnant girls and women 9 to 26 years of age. It is contraindicated during pregnancy, although evidence suggests it is safe if pregnant women receive it inadvertently.
Hepatitis B- A woman should get tested for anti-HBs before she is pregnant to see whether the vaccine was well taken and she is immune to infection.

Vaccines during pregnancy

The tetanus, diphtheria, acellular pertussis (Tdap) vaccine is recommended for every pregnant woman during each pregnancy. It should be given as early as possible between 27 and 36 weeks of gestation, to facilitate the passive transfer of maternal antibodies. Infants exposed in utero to Tdap vaccine were better protected against pertussis during the first year of life than infants not exposed in utero.

Influenza (flu)- Every pregnant woman who is pregnant around the influenza season should be vaccinated against the seasonal flu as she is at high risk for developing flu complications. The vaccine has no adverse effect on fetus, on the contrary the unborn baby is protected against flu for first 6 months of life, till the baby is eligible to receive the vaccine.
The nasal spray influenza vaccine is contraindicated as it is made of live virus.

Vaccines for special circumstances

Hepatitis A- Pregnant woman who is at risk for developing Hepatitis A should receive the vaccine as the virus can be passed on to fetus.
Hepatitis B- It is only recommended for pregnant women who are at high risk for developing the infection like unimmunized women who live with someone infected with hepatitis B and for completing the series if started before becoming pregnant.
Poliomyelitis- Although polio has been eradicated from most developed and some developing countries, polio vaccine is usually not given in pregnancy unless travel to an area where polio is prevalent is unavoidable. In such circumstances, she may receive the inactivated polio vaccine (IPV). 
Pneumococcus- Ideally the vaccine is given before pregnancy, but  if woman is at high risk for pneumococcal infection, the vaccine appears to be safe if given in second and third trimester.
Varicella- Because the effects of the varicella virus on the fetus are unknown, it is contraindicated in pregnant women.

Vaccines for travel

Yellow fever- May be given if benefit outweigh risk. 
BCG- contraindicated
Typhoid- Inadequate data to make any recommendations
Rabies – Pregnancy is not considered a contraindication for post-exposure prophylaxis. If risk of exposure is substantially high, pre-exposure prophylaxis could be considered.

Passive Immunization during pregnancy

No known risk exists for the fetus from passive immunization of pregnant women with immune globulin preparations.

Prenatal screening

Every Pregnant woman should be tested for immunity to rubella and varicella and be tested for the presence of HBsAg during every pregnancy. Women who are found susceptible to rubella and varicella should be vaccinated immediately after delivery.
If a woman is found to be HBsAg positive, the infant should receive HBIG and begins the hepatitis B vaccine series no later than 12 hours after birth.

Breastfeeding and vaccines.

Inactivated and live-virus vaccines are not contraindicated in pregnant woman, although the virus can replicate in mother, it is not excreted in human milk.

Small pox and yellow fever vaccines are contraindicated in lactating mother, although if travel to an area where Yellow fever is endemic is imminent, it can be given. 

Tuesday, May 30, 2017

Videssa Breast Blood Diagnostic Test: An innovative, non-invasive tool to rule out breast cancer.

Artist's rendering of measurable biomarkers released from a breast cancer tumor.
ProvistaDiagnostics, Inc. has developed the Videssa Breast blood test, the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer (BC). It is specifically useful in ambiguous clinical situation when women present with difficult to interpret imaging findings.

At present imaging [including mammography, ultrasound (US), magnetic resonance imaging (MRI), and 3-D tomosynthesis] is the gold standard for BC detection. But sometimes breast density, prior biopsy or lesion size can confound the diagnosis.  The physician faces a diagnostic dilemma about whether to go for a biopsy or wait further for reimaging after 6 months.

These imaging results usually fall in the Breast Imaging-Reporting and Data System [BI-RADS] categories 3 or 4.

e-book by Provista.
The e-book BREAST CANCER DETECTION can be downloaded here.

The diagnostic test use ELISA to evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. The Videssa Breast blood test has been studied in two prospective, randomized clinical trials, Provista-001 and Provista-002, across 13 domestic clinical sites.

A total of 545 women, ages 25-50, with BI-RADS categories 3 or 4 underwent the blood test. The study results showed a BC prevalence of nearly 6%. It has a very high negative predictive value (NPV) of 99.1 %, that means the clinician can quite accurately identify those patients who are unlikely to have BC after an ambiguous imaging result.

The test has positive predictive value (PPV) of 25.2%, which means it increases the number of breast biopsies that yield a positive BC diagnosis from 1 in 11 for imaging to 1 in 4.

Overall, when used prospectively along with imaging, Videssa Breast reduceds unnecessary biopsies by up to 67%, compared with standard imaging modalities (p < 0.0001).

The authors concluded “Therefore, this study supports the use of Videssa® Breast, concomitant with imaging, to help guide the management of women under the age of 50 with challenging imaging findings.”

"With about 1.6 million breast biopsies performed each year,1 the implications of a blood test that can help clinicians confidently rule out breast cancer and avoid a potentially unnecessary biopsy are tremendous," said Judith K. Wolf, MD, Chief Medical Officer of Provista Diagnostics, Inc

Monday, May 29, 2017

World’s first system to eliminate surgical smoke and improve visibility in laparoscopic or robot-assisted procedures gains FDA approval.

courtesy:Cardiff University
Alesi Surgical Limited, leading innovator of Minimally Invasive Technology gains FDA approval for its Ultravision system. It is world’s first technology that not only clears surgical smoke, but eliminates it to improve visibility of the surgical field. Particulate matter and smoke is generated by cutting instruments during the modern laparoscopic abdominal surgeries obscuring the surgical field.

Dr Dominic Griffiths, Managing Director of Alesi Surgical said “We are thrilled to have gained FDA approval for our Ultravision system that will now allow us to enter the US market. Commercially the US represents approximately fifty per cent of the global medical device market and so it is difficult to overstate the importance of this for the company.”

When a surgeon uses Ultravision, the surgery is quick, requires few lens cleaning along with significantly less use of carbon dioxide. Keyhole surgeries are known to use several hundred liters of carbon dioxide to get a clear vision of the surgical field, which prolongs the recovery time and causes post-surgical pain.  

The Ultravision system works by producing negatively charged gas ions in the abdominal cavity, which move towards the “positive” patient tissue. As the ions move, they collide with water vapour and particulate matter and draw them away from the surgical site. Particles land, and the electrical charge flows back to the generator.

After 1 minute of continuous use, smoke evacuation removes 30.2% of particles (by number) In the same time period Ultravision™ precipitated 99.9% of particles, independent of particle size, from 7nm to 10µm (p<0.05).

It is estimated that over seven million abdominal keyhole procedures are performed annually, worldwide.

                             The video demonstrates the mode of action of Ultravision.

Sunday, May 28, 2017

An inexpensive intervention reduces maternal mortality due to Post-partum hemorrhage.

An inexpensive intervention like Tranexamic acid (TXA) has the potential to significantly reduce maternal death due to Post-Partum hemorrhage(PPH) when used in timely manner, report the results of large randomized control trial.

The WOMAN (World Maternal Antifibrinolytic) Trial results along with an accompanying editorial were published online April 26, 2017 in Lancet.

Primary Post-partum hemorrhage is responsible for about 100 000 deaths every year primarily in developing countries and in low resource settings.

Before the WOMAN trial, tranexamic acid was shown to be effective in surgical blood loss and trauma cases but a review of literature failed to document any research in use of tranexamic acid in postpartum hemorrhage. Interestingly, the drug was originally developed for controlling hemorrhage in obstetrics and gynecology.

Further, WHO guideline in 2012 recommended “tranexamic acid should be used for the treatment of post-partum hemorrhage when uterotonics fail to control the bleeding or when the bleeding is thought to be due to trauma,” but the results were extrapolated from surgery or trauma cases.

Comprising of 20,060 patients with a clinical diagnosis of PPH during normal or cesarean delivery, the WOMAN trial spanned across 193 hospitals in 21 countries.

All patients received normal obstetric care and were randomized to receive 1 g tranexamic acid or placebo by slow intravenous injection. If bleeding persisted after 30 minutes or restarted after once controlled within 24 hours, a dose of TXA was repeated.  

Trial results were evaluated in terms of number of deaths from all causes or hysterectomy within 42 days of drug administration. Deaths due to bleeding was also looked at as main secondary outcome.
The results showed that treatment with TXA reduces the chances of death due to bleeding by almost 20% as compared to placebo (risk ratio [RR], 0.81; P = .045). The effect was maximum when TXA was used within 3 hours of delivery (RR, 0.69; P = .008).

When the drug was used after 3 hours, there was no significant reduction in risk of death due to bleeding (RR, 1.07; P = .70).

The risk of death due to hysterectomy and all causes or hysterectomy including pulmonary embolism, organ failure, sepsis, and eclampsia were similar between the study and control group.

TXA did not increase the risk of thromboembolic events as compared to placebo.

An accompanying editorial writes that “Hemorrhage accounts for 18% of these deaths, and is a particularly important cause of maternal mortality in Africa and Asia. Discovering new ways to prevent maternal death, especially from bleeding, therefore continues to be a high priority, and WOMAN trial is an important milestone in that quest.”

The authors recognize that most deaths due to PPH occur in developing or low resource setting countries, where administering IV TXA may not be feasible.  So, studies investigating alternate routes of TXA administration should be planned.

The trial also supported the WHO recommendation of inclusion of tranexamic acid in treatment guidelines for primary postpartum hemorrhage but with a caveat that it should be given as soon as possible.

Full text of the article can be accessed here.

Full text of the editorial can be accessed here.

                                          Woman Trial: Tranexamic acid for the treatment of PPH

Zika fever: our newest dread disease. What is it? Where'd it come from?

Where did Zika come from, and what can we do about it? Molecular biologist Nina Fedoroff takes us around the world to understand Zika's origins and how it spread, proposing a controversial way to stop the virus — and other deadly diseases — by preventing infected mosquitoes from multiplying.

Nina V. Fedoroff, Ph.D is Science and Technology Advisor to the Secretary of State, and Evan Pugh Professor of Biology and Willaman Professor of Life Sciences, Huck Institutes of the Life Sciences, Pennsylvania State University, University Park, PA, USA

A TED talk by Nina Fedoroff

Friday, May 26, 2017

Power Morcellator: A Boon or Curse ? Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

Amy Reed, MD, PhD, an anesthesiologist died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laproscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

The surgery took place at the Harvard-affiliated Brigham and Women’s Hospital in Boston where both Reed and her husband Noorchashm worked.

She came to know about the diagnosis only after the histopathology reports came in after the surgery. To date, there isn’t a reliable method to determine whether or not a uterine tumor is malignant before it has been removed and fully examined. The estimated incidence of leiomyosarcoma is 0.64 per 100,000 women.

The couple immediately knew they were in trouble and it was just a race against time. 
She turned her calamity into advocacy against the use of power morcellator and have fought an uphill battle to ban morcellation.  

Introduced to the United States in 1993 and approved by the FDA in 1995, the device gained rapid popularity among gynecologists particularly for the removal of fibroids and in hysterectomies.

It is estimated that Power Morcellator is used in about 600,000 minimally invasive hysterectomies and myomectomies annually.

Traditional cancer therapies were all ineffective as the morcellation has already advanced the cancer to stage IV. She fought an epic battle against the deadly disease along with a campaign to ban morcellation. She and her husband wrote numerous emails to FDA, along with device makers and hospitals and legislators. They also waged the war on social media and other traditional medias.

It is because of her efforts that FDA revisited the literature and made an announcement on April 17, 2014 “Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

“For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Soon, after this FDA newsletter, Johnson & Johnson pulled its device off the market.

Morcellator use dropped after this, but was not completely banned. By September 2016, the FDA received 285 additional reports of cancer spread by morcellation.

Many gynecologist surgeons however, continue to use the morcellator. In 2014, ACOG issued a position statement on Power Morcellation quoting that while it supports FDA commitment to women’s health, but believe that power morcellation has a role in gynecologic surgery. A careful selection of cases and evaluation of woman’s risk for leiomyosarcoma plus informed consent can protect women against the negative outcome. 

Following the ongoing controversy, on April 7, 2016, FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy.

However, FDA requires the manufacturer to warn patients and health care providers that the containment system has not been proven to reduce the risk of spreading cancer during power morcellation.

FDA recommendation can be accessed here.

ACOG full statement can be accessed here.

Drs. Noorchashm and Reed make a joint presentation at a symposium focused on FDA law and law enforcement at Widener University Law School.

Thursday, May 25, 2017

ACOG updates its recommendations for estimating gestational age and due date: May 2017

Accurate gestational dating of pregnancy is very important for optimal maternal and fetal outcome.Throughout pregnancy decisions like ordering and interpreting lab tests, determining fetal growth and performing intervention to prevent preterm births or post-term pregnancies and associated morbidities are based on accurate dating.

Estimated Due Date (EDD)and current gestational dating should be documented on medical records and discussed with the patient as early as possible based on dates of Last Menstrual Period(LMP) and earliest available ultrasound in pregnancy.

A first trimester ultrasound can improve the accuracy of predicted EDD, even if date of LMP is known. Many women have irregular cycles, or falsely recall the date of LMP or have irregular ovulation, which is not considered when calculating the EDD by traditional method.

The American College of Obstetricians and Gynecologists, the American Institute of Ultrasound in Medicine, and the Society for Maternal–Fetal Medicine make the following recommendations regarding the method for estimating gestational age and due date:

A first trimester ultrasound of the embryo (up to and including 13 6/7 weeks of gestation) is most accurate for calculating or confirming the gestational age. Measuring the crown–rump length (CRL) is accurate up to ±5–7 days and it should be the mean of three discrete CRL measurements when possible.

If the pregnancy is the result of successful ART procedure, then the EDD is calculated based on age of embryo and day of transfer.

As soon as LMP and results of first trimester ultrasound are known, EDD should be calculated and recorded in medical records. It should also be told to patient and discussed with her.

Second trimester ultrasound for gestational dating (14 0/7 weeks to 27 6/7 weeks of gestation) is more complex and introduces more complexities and variability. It incorporates multiple parameters like the biparietal diameter and head circumference, the femur length and the abdominal circumference. The accuracy decreases as we progress further into second trimester, with a variability of ± 10–14 days at the end of second trimester.

Gestational age assessment by ultrasonography in the third trimester (28 0/7 weeks of gestation and beyond) is the least reliable method, with an accuracy of ± 21–30 days.

Pregnancies without an ultrasound examination that confirms or revises the EDD before 22 0/7 weeks of gestational age should be considered suboptimally dated and managed accordingly.

This document replaces the Committee Opinion Number 611, (October 2014).

The full text of the committee opinion can be accessed here. 

Wednesday, May 24, 2017

Preeclampsia Foundation Initiates First Global Preeclampsia Day

To help build awareness of pre-eclampsia outside the United States, the Preeclampsia Foundation partnered with other like-minded organizations to sponsor the first-ever World Preeclampsia Day on Monday, May 22, 2017.

Planning is underway and involves multiple global advocacy and professional organizations including representatives from Australia, Brazil, Ireland, the Netherlands, and Norway among many others.

Elagolix shows promising results for long term treatment of endometriosis

Elagolix has the potential to be an important treatment option for long term medical treatment for Endometriosis, reports the results of two replicate, randomized double blind, phase III studies. The paper was presented at the 13th World Congress on Endometriosis in Vancouver, Canada and simultaneously published in the New England Journal of Medicine.

Elagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, oestradiol and progesterone, while on therapy.

Medical management of Endometriosis requires treatment for extended period and physicians currently have very limited options in this regard. Treatment with gonadotropin-releasing hormone (GnRH) agonists, such as leuprolide acetate cannot be extended beyond 6 months because of osteoporosis and sever vasomotor symptoms.

These two-trial recruited 1,689 premenopausal women between the ages of 18 and 49 years, who had endometriosis and suffered from moderate to severe pain and had a z score of more than -1.5 for bone mineral density at the lumbar spine, femoral neck, or total hip. The study participants were from 151 sites in the United States and Canada from July 2012 through May 2014 and for Elaris EM-II at 187 sites on five continents from November 2013 through July 2015.

Each woman was randomly assigned to receive 150 mg of elagolix once daily (lower-dose group), 200 mg of elagolix twice daily (higher-dose group), or placebo.

The results were evaluated in terms of proportion of women who had clinical response for dysmenorrhea and non-menstrual pain after 3 months of treatment. Other relevant clinical parameters tested were dyspareunia, use of rescue NSAIDs and opioids, dyspareunia and non-menstrual pain at 6 months of treatment.

In both the trials, women showed statistically significant response in terms of dyspareunia and non-menstrual pain at 3 months of treatment as compared to placebo. The response was sustained at 6 months of treatment for these two parameters.

Women who received the higher dose of elagolix (200 mg twice daily) had significantly better results with respect to the use of rescue analgesic agents at 3 months and 6 months, dyspareunia at 3 months, and rescue opioid use at 3 months than did those receiving placebo.

Treatment with Elagolix improved the quality of life based on the 30-item Endometriosis Health Profile dimensions in both groups as compared to placebo.

Because of its hypoestrogenic effect, more than 70% women in the trial reported adverse effect including hot flushes and changes in bone mineral density and lipid levels but the frequency differed significantly between the higher and lower dose groups.

Professor Hugh Taylor, lead author of the resulting paper said, “The idea that we now have choices with regards to the extent of oestrogen suppression is attractive, as it allows us to provide a more personalised and individualised therapy.”

“With elagolix – unlike with Lupron (leuprolide acetate)– we can partially suppress oestrogen, unlike the “all or nothing” current approach,” he further added.

Elagolix is currently being investigated in uterine fibroids and endometriosis, and has been studied in over 40 clinical trials totalling more than 3,000 women. AbbVie, the makers of the drug, plans to submit a New Drug Application to the US Food and Drug Administration (FDA) for endometriosis in 2017. 

Full text of the article in NEJM can be accessed here

Tuesday, May 23, 2017

Hysterosalpingography with oil-based contrast boosts pregnancy rates: A landmark study

Infertile women undergoing Hysterosalpingography (HSG) with an oil based contrast have a 10% higher chances of getting pregnant and continue the pregnancy as compared to women who have HSG with a water based medium reports results of a multicentric, randomized trial from Netherlands.

The study was published online May 18 in the New England Journal of Medicine and presented at the 13th World Congress on Endometriosis in Vancouver, Canada.

Looking back, the debate about superiority of one medium over other has been going on for 50 years. It is known that flushing of the fallopian tube enhances fertility, but controversy about the type of medium continues.

First HSG was carried out by Carey in 1914 and he used collergol. Lipiodol was introduced by Sicard and Forestier in 1924 and remained a popular contrast medium for many decades. Later, water-soluble contrast material was generally preferred as it avoided the possible complication of oil embolism.

A 2007 update of Cochrane review concluded that “Flushing of the tubes with oil-soluble media increases subsequent pregnancy rates in infertility patients. Clinicians should consider flushing the tubes with OSCM before contemplating more invasive therapies.”

While other smaller studies have reported that contrast does not affect the cumulative pregnancy rate.

The current study called the The H2Oil study was conducted by Professor Ben W.J. Mol along with Dr. Kim Dreyer & Dr. Velja Mijatovic from the Department of Reproductive Medicine, VU University Medical Centre, Amsterdam, and their multi-center research team from 27 hospitals in the Netherlands.

The study recruited 1,119 women who were undergoing fertility treatment and were advised hysterosalpingography (HSG). The women were randomized to a standard HSG with water-soluble contrast medium (WSCM)(Hystero) or another group which used an oil-based contrast with Lipiodol Ultra-Fluide. (LIPIODOL Ultra-Fluid 480 Injection 10 mL, GUERBET). (Ethiodol in the United States). Then couples received expectant management or the women underwent intrauterine insemination.

All women were between 18 and 39 years of age, with regular menstrual cycles, and were undergoing treatment for infertility for at least 1 year.

The primary outcome measure was positive fetal heart rate by USG at 12 weeks of pregnancy within 6 months of the HSG test. Multiple secondary outcomes were tested like positive pregnancy test by USG, live birth, ectopic pregnancy, miscarriage and pain scores by the Visual-Analogue Scale for Pain.

After statistical analysis at 6 months, it was seen that 220(39.7%) in oil-based group had an ongoing pregnancy versus 161(29.1%) in water based group (P <.001). The oil based group also had considerable more live birth rates, 38.8% versus 28.1% (P <.001).   

Professor Mol said “This means that for every ten women undergoing an HSG to test their fallopian tubes, if Lipiodol® is used for that test, there will be one more pregnancy six months later and, consequently, one more baby nine months after that.”

The groups were comparable to each other in terms of bilateral tubal patency, pain score, miscarriage rates, ectopic pregnancy, twins, stillbirth rates and median duration of pregnancy.  

“If we move to the use of Lipiodol® Ultra-Fluid for routine diagnostic tubal patency testing, more women will have a successful fertility outcome and will avoid the need for other expensive fertility treatments such as IVF. I believe that is justifiable at this point,” he further added.

Professor Mol has a personal connection with the study which came to light only when he started researching about HSG. He himself was born, after his mother underwent HSG using Lipiodol after being infertile for 9 years.  

Professor Neil Johnson, President of the World Endometriosis Society concluded “This new study from our Dutch colleagues confirms beyond doubt the fertility value of Lipiodol® Ultra-Fluid.”

Monday, May 22, 2017

Digital health trackers making pregnancy and delivery safer for mother and her newborn

Pregnancy wearables are revolutionizing the experience of pregnancy and motherhood by digitally tracking the health of mother and her unborn child.  The global wearables market is predicted to reach the value of over US$30 billion in the next five years with pregnancy app industry and wearables occupying a major market share.

Apple CEO Tim Cook said, “Users Will Trust Health Apps More Than Their Doctors in near future,” during an Apple event in San Francisco.

A variety of wearables and health apps are available for women, right from tracking her fertility and helping her getting pregnant until labor and beyond.

MyHealthbee is a website that have a comprehensive database of apps and products created for more than 60 health and wellness conditions, ranging from right before conception to delivery and beyond. It includes fertility tracker, pregnancy, newborn care and early child development monitors and many more.

Earlier we have learned about Ava: The First Fertility Tracking Sensor Bracelet. Once you are already pregnant, the 9 months’ adventurous journey towards motherhood begins.

Reliefband Neurowave

In the first trimester, nearly 80% of women experience morning sickness, the Reliefband Neurowave,is FDA approved, simply drug free, life-changing wearable device to treat morning sickness which is worn like a watch.

As you advance into your pregnancy, we have wearables that can play music to the unborn child. Many women speak to their babies in pregnancy and in Indian Mythology, the story of Abhimanyu is known to all of us who knew the art of fighting on battlefield because he has heard his parents talking about it when in womb.

The Bellybuds 
Around week 25 or 26, babies in the womb have been shown to respond to voices and noise. Recordings taken in the uterus reveal that noises from outside of the womb are muted by about half.
Study in the Proceedings of the National Academy of Sciences reinforces that babies can hear and distinguish sounds in womb.

Currently, 5 Prenatal Sound Systems to play music in the womb are available. Lullabelly is the safe, comfortable, and convenient way to play music to your baby in the womb whether at home or on the go. It is an ultrasoft, lightweight, machine washable belt that can be worn over any apparel. It has got a large pocket to carry the music system, making it hands free and user-friendly.

It comes with audio splitter so that the mother can listen to it too.

Lullabelly speakers have volume control disc and the maximum volume reached is equal to mother and father speaking or singing loudly to the baby in womb. Shop Lullabelly Prenatal Music Belt and Bellybuds here

Sound Beginnings prenatal sound system high quality speakers keep the volume under safe limit. Other similar gadgets are Ritmo, Bellysonic and Bellybuds. Bellybuds are specialized bellyphones that gently adhere to your belly and play music.

If you have reached the third trimester than Bloomlife is a wearble that will measure and monitor your contractions and store the data in an app for iOS or Android that is easy to monitor. It is attached to the belly and electronically picks up the contractions of the uterine muscles.

Bloomlife contraction tracker 

The battery and the reusable strip last for a week. As this is something that has no longterm use, it is also available on rent for 1-3 months. The company is expecting to get FDA approval in future.

Ultra stan 
Ultra stan is finally an ultrasound scanner and let parents hear and see the baby in womb whenever they want and wherever they want. Simply link Ultra Stan to the BleepBleeps smartphone app and it can record videos and audio of baby in the womb, and take photos as he or she somersaults and kicks away.

And now would be fathers can also be able to feel their unborn baby kicking in the womb, thanks to The Fibo bracelet, developed by First Bond Wearables.

Fibo bracelet for men.
The mother is wearing a kick monitor patch, developed by another start-up.

“So, when the baby kicks or moves, it sends a signal via GSM to an elegant smart bracelet that imitates the movements. The sharing happens instantly so the person wearing the wristband will feel the movement in real-time.” Said Sandra Pétursdóttir from First Bond Wearables.

An Innovative, High Tech bangle which goes by the name Coel was recently launched successfully by Grameen Intel Social Business Ltd in  Bangladesh,Asia. The app will deliver  pregnancy wellness tips to women in remote  Asia.

 Qardiobase smartscale

Finally, there are Smart Scales and Smart Body Analyzers which measure the weight, body fat measurements and BMI and automatically transfer data to smart phone apps.

There are also wearables and apps for babies before they are born.

A study published in BMC Pregnancy and Childbirth reports that women value the use of modern gadgets and apps during pregnancy and urge the healthcare providers to include the information about these digital wearables and apps in planning pregnancy care.

Saturday, May 20, 2017

Vaginal Progesterone supplementation decreases preterm births, neonatal morbidity and mortality in women with twin gestation and short cervix: an updated meta-analysis of individual patient data

Administration of vaginal progesterone to asymptomatic women with a twin gestation and a sonographic short cervix (cervical length ≤ 25 mm) in the mid-trimester reduces the risk of preterm birth occurring at < 30 to < 35 gestational weeks, neonatal mortality and some measures of neonatal morbidity, without any demonstrable deleterious effects on childhood neurodevelopment.

The article was published online in Ultrasound in Obstetrics and Gynecology, the official journal of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG).

The meta-analysis included the results of 6 studies, encompassing 303 women pregnant with twins, all of whom had a cervical length of 25 mm or less in the midtrimester. Of these, 159 women received vaginal progesterone and 144 received a placebo or no treatment. Women who received vaginal progesterone were 31 percent less likely to deliver before 33 weeks of pregnancy (31 percent for those receiving vaginal progesterone, compared to 43 percent for those who did not). Vaginal progesterone also reduced the rate of preterm delivery before 32 weeks and 34 weeks. All results were statistically significant.

The risk of preterm birth < 33 weeks was reduced by 31% and neonatal death by 47% and also reduced the rate of respiratory distress syndrome (RDS), birth weight < 1500 g and use of mechanical ventilation.

No significant difference in the risk of neurodevelopmental disability at 4–5 years of age between children exposed prenatally to vaginal progesterone and those exposed to placebo.

“The findings represent persuasive evidence that treatment with vaginal progesterone in women with a short cervix and a twin gestation reduces the frequency of preterm birth, neonatal complications such as respiratory distress syndrome, and importantly, neonatal death,” said the study’s first author, Roberto Romero, M.D., Chief of the Perinatology Research Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH). Dr. Romero emphasized that individual patient data meta-analyses represent the “gold standard” in the hierarchy of scientific evidence to answer clinical questions.

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The accompanying videoclip by the  ISUOG summarizes the importance of research.