A year in review: Best of 2017

We are already round the corner to 2018, here are the top 10 most read articles from 2017.

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 2017 showed that changing the outer gloves before closing the abdomen decreases the wound complication of infection, cellulitis and dehiscence.

https://obgynupdated.blogspot.com/2017/05/news-from-acog-2017-changing-gloves.html

Clinical review: Updates on Cesarean Section

Here is a roundup of the latest research on Cesarean Section.

https://obgynupdated.blogspot.com/2017/08/clinical-review-updates-on-cesarean.html

The American Heart Association updates BP guidelines in 14 years: now 130 is the new 140

The American Heart Association (AHA)  and The American College of Cardiology (ACC) has changed the definition of hypertension for the first time in 14 years, moving the number from the old standard of 140/90 to the newly revised 130/80.

According to the new definition, 130 to 139 mm Hg systolic and or 80 to 89 mm Hg will be labelled as stage 1 hypertension.

https://obgynupdated.blogspot.com/2017/11/the-american-heart-association-updates.html

First US baby born after uterine transplant delivered in Texas

The first birth as a result of a uterine transplant in the United States took place on Friday in Texas at the Baylor University Medical Center in Dallas. The women had undergone a live donor transplant and have received her uterus from Taylor Siler, 36, a registered nurse in the Dallas area.

https://obgynupdated.blogspot.com/2017/12/first-us-baby-born-after-uterine.html

New use of old drug: Sildenafil Citrate (Viagra) improves amniotic fluid index in oligohydramnios.

Sildenafil Citrate (Viagra) improves amniotic fluid index in pregnancies complicated by oligohydramnios according to a new study published ahead of print on March 6,2017 in Journal of Obstetrics and Gynecology.

https://obgynupdated.blogspot.com/2017/03/new-use-of-old-drug-sildenafil-citrate.html

WHO updates its guidance on Tranexamic Acid for the Treatment of Postpartum Hemorrhage

WHO has recently updated their guidelines for use of Tranexamic acid for treatment of Postpartum Hemorrhage: TXA should now be included in the treatment regimen for PPH along with other drugs, irrespective of the cause of hemorrhage.  

https://obgynupdated.blogspot.com/2017/11/who-updates-its-guidance-on-tranexamic.html

CDC releases ‘long awaited’ guidelines for preventing surgical site infections.

The Center for Disease Control released its 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.

https://obgynupdated.blogspot.com/2017/05/cdc-releases-long-awaited-guidelines.html

Finally, an oral drug found effective in treatment of Uterine Fibroids following successful phase-3 trial

Relugolix successfully reduced heavy menstrual blood loss among Japanese women in a Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral relugolix 40 mg as compared with injectable leuprolide in the Treatment of Uterine Fibroids.

https://obgynupdated.blogspot.com/2017/10/finally-oral-drug-found-effective-in.html

Now ‘Switch’ the way you suture: Reinventing suturing technique with the new device

Mellon Medical, a Dutch MedTech developer has reinvented suturing by developing a device which enables the surgeon to suture with only one hand, the other hand remaining free to use as needed. The product is named Switch®, a single use precision instrument that allows the surgeon to suture tubular structures or skin with twice the speed of conventional suturing.

https://obgynupdated.blogspot.com/2017/10/now-switch-way-you-suture-reinventing.html

A simple, novel solution to identify and protect ureter during surgery

AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held, single use device that precisely identifies ureter during surgery; thus, eliminating the need for ureteral stenting.

https://obgynupdated.blogspot.com/2017/12/a-simple-novel-solution-to-identify-and.html

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

Finally, an oral drug found effective in treatment of Uterine Fibroids following successful phase-3 trial

Relugolix successfully reduced heavy menstrual blood loss among Japanese women in a Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral relugolix 40 mg as compared with injectable leuprolide  in the Treatment of Uterine Fibroids.

Relugolix is an oral, once-daily, small molecule GnRH receptor antagonist that has been evaluated in almost 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, it has shown to suppress estrogen and progesterone levels in women and testosterone levels in men. (It is also being evaluated in advanced prostate cancer via ongoing phase-3 HERO study).

https://obgynupdated.blogspot.com/2017/10/finally-oral-drug-found-effective-in.html

Now ‘Switch’ the way you suture: Reinventing suturing technique with the new device

Mellon Medical, a Dutch MedTech developer has reinvented suturing by developing a device which enables the surgeon to suture with only one hand, the other hand remaining free to use as needed. The product is named Switch®, a single use precision instrument that allows the surgeon to suture tubular structures or skin with twice the speed of conventional suturing.

https://obgynupdated.blogspot.com/2017/10/now-switch-way-you-suture-reinventing.html

ACOG updates its guidelines on LARC

The American College of Obstetricians and Gynecologists (ACOG) today updated its guidelines on Long-Acting Reversible Contraception(LARC): Implants and Intrauterine Devices. These updated guidelines were published online October 24 in Obstetrics & Gynecology and replaces the old practice bulletin published in July 2011.

https://obgynupdated.blogspot.com/2017/10/acog-updates-its-guidelines-on-larc.html

ACOG updates guidance on postpartum hemorrhage- calls for standard, coordinated, protocol based intervention

The American College of Obstetricians and Gynecologists (ACOG) recently released expanded guidelines for management of postpartum hemorrhage (PPH)—the leading cause of maternal mortality worldwide.

PPH is defined as total blood loss of 1000 ml or more along with signs or symptoms of hypovolemia within 24 hours after the labor, but can occur up to 12 weeks postpartum. Although Maternal Mortality Rates(MMR) have decreased worldwide in last 4 decades, it still accounts for 10% of all pregnancy related mortality.

https://obgynupdated.blogspot.com/2017/10/acog-updates-guidance-on-postpartum.html

Endometriosis fertility index can accurately predict a women’s chances of conception after laparoscopy

The Endometriosis fertility index can accurately predict the possibility of non-ART conception or the need of ART for achieving pregnancy after surgical resection of moderate-severe (Stage III–IV) endometriosis reports the results of study published in Human Reproduction. The study confirmed that adnexal function is deciding factor in evaluation of fertility prognosis after the surgery.

There is no evidence based guidelines about post-surgery fertility management of women who have undergone surgery for severe endometriosis. Physicians differ in their approach about the length of conservative treatment and that sometimes add years and causes unnecessary delays.

https://obgynupdated.blogspot.com/2017/10/endometriosis-fertility-index-can.html

Finally, an oral drug found effective in treatment of Uterine Fibroids following successful phase-3 trial

Relugolix successfully reduced heavy menstrual blood loss among Japanese women in a Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral relugolix 40 mg as compared with injectable leuprolide  in the Treatment of Uterine Fibroids.

Relugolix is an oral, once-daily, small molecule GnRH receptor antagonist that has been evaluated in almost 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, it has shown to suppress estrogen and progesterone levels in women and testosterone levels in men. (It is also being evaluated in advanced prostate cancer via ongoing phase-3 HERO study).

The drug is being developed by Switzerland’s Myovant Sciences along with Japan’s Takeda. They said that these results will support the other ongoing global trials evaluating the drug in endometriosis and uterine fibroid patients.

"The positive results of decreased menstrual bleeding from Takeda's Phase 3 study of relugolix in Japanese women with uterine fibroids provides strong support for Myovant's ongoing Phase 3 studies with relugolix in North America, Europeand other regions," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences in a press release. 

"Uterine fibroids result in debilitating heavy menstrual bleeding and anemia in millions of women throughout the world, oftentimes requiring a hysterectomy to control the bleeding.  Myovant is working to develop relugolix, an oral, once-daily medication that can potentially provide women with an alternative option to major surgery for the treatment of uterine fibroids."

The study recruited 288 women with heavy menstrual bleeding associated with uterine fibroids. They were randomized to receive either relugolix 40 mg, administered orally once daily, or leuprolide acetate, an injectable GnRH agonist, administered by subcutaneous injection every four weeks, at a dose of 1.88 mg or 3.75 mg, for 24 weeks. 

The amount of blood loss was assessed by Pictorial Blood Loss Assessment Chart, or PBAC self-reported by patient themselves. At entry into study all patient had PBAC ≥ 120.

In the study, relugolix successfully demonstrated that it was as good as leuprolide acetate with 82.2% of patients achieving a score of less than 10 on the PBAC, compared with 83.1% of patients treated with leuprolide acetate (p = 0.0013).

The incidence of adverse effects was nearly similar and varied according to the drug. Another phase 3 trial with relugolix is currently ongoing in Japan with 70 patients who also complained of pain because of fibroids.

Two more trials (LIBERTY 1 and LIBERTY 2) are ongoing and were initiated by Myovant in January 2017.  These trials are looking at reducing heavy menstrual blood loss by relugolix alone followed by leuprolide  as monotherapy, relugolix combined with low dose leuprolide  or placebo for 24 weeks. 

These two trials are looking at reduction in blood loss by at least 50%, decrease in pain and size of fibroid and safety of the drug, as evident by bone -mineral density.

Myovant is solely responsible for obtaining Food and Drug Administration (FDA) approval for relugolix in the United States and the results of Takeda study will definitely reinforce its application. 

The drug is also currently tested by two phase-3 ongoing trials for relieving endometriosis associated pain, named as SPIRIT 1 and SPIRIT 2. These two trials are still recruiting patients and will run through 2020. The trials will evaluate relugolix with and without low-dose hormonal add-back therapy, to avoid the iatrogenic menopausal side effects.