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Newsletter Featuring research studies conducted by the
Center for Women’s Reproductive Health/OBGYN Department
[email protected] us at: November 2019
In 2019, the NIH committed $945 million in research funding to
tackle the opioid crisis through the NIH Helping End Addiction
Long-Term (HEAL) Initiative. The UAB Center for Women’s
Reproductive Health is participating in two of these
initiatives.
1) Led by Dr. Ambalavanan of Neonatology, UAB is a participating
Research Center for the Advancing Clinical Trials in Neonatal
Opioid Withdrawal (ACT NOW) Longitudinal Study. Known locally as
the Outcomes of Babies with Opioid Exposure (OBOE) Study, we will
be recruiting women and their infants with opioid exposure, in
addition to non-exposed normal controls, and will follow the
infants for up to two years after delivery. The goals of the study
are to quantify the effects of antenatal opioid exposure on the
trajectory of brain development over the first 2 years of life,
determine associations with developmental and neurobehavioral
outcomes, and explore how specific factors (differing antenatal and
postnatal exposures, severity of neonatal opioid withdrawal,
maternal stress/depression/parenting) modify these effects. UAB’s
participation in this study represents a joint effort between
Neonatology, Radiology, MFM (CAPP Clinic), and the CWRH. CWRH looks
forward to continued successful collaborations with our Neonatology
partners.
2) The MFMU is leading a trial in the NIH HEAL Initiative Pain
Management Effectiveness Research Network. Anticipated to start in
January 2020, the Prescription after Cesarean Trial (PACT) will
examine the best way to treat pain post-Cesarean delivery. While
UAB has been using individualized opioid prescribing for discharge
medications, many institutions and practitioners continue to
prescribe large amounts of opioids. The goal of this study is to
compare a shared-decision making with individualized opioid
prescriptions versus a set amount of 20 oxycodone pills. The
primary outcome of this study is patient pain and satisfaction at 2
weeks after discharge, but we will follow women for up to 90 days
after cesarean section to assess if they are still using opioids.
We will be working on how best to communicate with the postpartum
teams who is participating in the study and what their prescription
should be for. This ambitious study plans to enroll 5500 women at
12 network sites in 18 months – based on the success of TXA at UAB,
we know we can be the lead recruiting site in the network on this
one!
NIH Helping End Addiction Long-Term (HEAL) Initiative
Mission and Goals: The overall goal of this robust
multidisciplinary initiative is to leverage the long-standing
success of the Center for Women’s Reproductive Health (CWRH) as an
international leader in reproductive health (RH) research to
enhance interdisciplinary collaborations across UAB campus focusing
on women’s RH. The mission of the CWRH is to conduct research aimed
at improving the reproductive health (RH) and wellbeing of all
women and their offspring, especially minority and under-served
(including those in rural Alabama). It is also to facilitate
collaboration between UAB researchers and developing scholars
interested in women’s RH. The major research themes at CWRH are
currently maternal/child health and gynecologic conditions
including genitourinary disorders and cancer prevention (reflecting
the spectrum of benign conditions in women as they age) and their
intersection with infections, cardiovascular disorders,
obesity/diabetes, neurodevelopment and global health. The CWRH has
built a reputation of excellence in women’s RH research over the
last three decades.The leadership plans to use UWIRC funds to
promote interdisciplinary RH initiatives and programs that
transcend the department. Over the next 5 years, the CWRH aims to
grow current research programs including global health, expand to
other RH areas including common general problems of reproductive
and post-reproductive aged women, family planning and cancer
prevention. It plans to continue to diversify its funding sources
beyond NIH and industry to other government and non-profit
agencies.
Structure, Governance and Leadership: The CWRH comprises
multidisciplinary scientists (faculty/investigators) and trainees
interacting with staff who are organized into five functional cores
with dedicated infrastructure. The executive leadership committee
responsible for day-to-day management is made up of the Center
Director, Associate/Assistant Directors and leaders of each of the
cores. The CWRH Director, Alan T. Tita, MD, PhD, is Vice Chairman
for Research in OBGYN and PI of the NICHD Maternal-Fetal Medicine
Units (MFMU) Network. The Associate Director for Obstetric Research
is Lorie Harper, MD, MSCI. The Associate Director for Gynecologic
Research is Holly E. Richter, PhD, MD who oversees benign
gynecologic research.
Membership: The CWRH formally nominates/appoints center
scientists (Associate Scientist, Scientist or Senior Scientist) in
recognition of previous or ongoing collaborations with the center.
Currently there are 73 members from 26 departments in eight UAB
schools including Business, Dentistry, Medicine, Nursing, Public
Health, Health Professions, Engineering and Arts &
Sciences.
UWIRC Job Announcements:TBN, Assoc Dir, Global WRH A new CWRH
Associate Director will be named to oversee the emerging thematic
area of Global Health. This position will be competitively filled
from our membership with priority placed on a member from
departments other than OBGYN.
TBN, Assoc Dir, Maternal and Child Follow-up A new CWRH
Associate Director will be named to oversee the area of post
pregnancy Maternal and Child follow up studies. This position will
be competitively filled from our membership with priority placed on
a member from departments other than OBGYN .
Administrative Contact for UWIRC: Richard Sarver,
[email protected]; 205.934.6349
https://www.uab.edu/medicine/obgyn/research
CWRH awarded University-Wide Interdisciplinary Research Center
(UWIRC) status
for the FY20-24 funding cycle
Alan T. Tita, MD, PhD
Lorie Harper, MD, MSCI
Holly E. Richter, PhD, MD
mailto:[email protected]
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Newsletter
In this edition of the newsletter, we celebrate the long career
and many contributions of Gail Williams to the UAB Department of
OB/GYN. Gail began her journey at UAB in 1971 as a labor and
delivery nurse. In 1974, she joined the department and has served
in many roles over the years. This year is the 50th anniversary of
UAB which was born in 1969. Thus, Gail has been at UAB for 96% of
the time UAB has existed. She was already a fixture when I was
first introduced to the department in 1981 as a medical student and
has known me throughout my career. I have many fond memories of
Gail as a nurse, manager and department leader. As the department
has grown, we have leaned on Gail for so many tasks including
moving clinics (over and over it seems), managing outpatient
services, developing programs and responding to urgent and emergent
needs. Never once has Gail ever hesitated to pitch in or have I
ever heard her complain.
I have had the opportunity to know many OB/GYN departments
across the country and I can say unequivalently that our department
is special and unique. This is true in part because of the original
architect of our department, Dr. Charles Flowers, Jr., but more
importantly because of the incredible input of everyone in the
department. Gail is an outstanding example of the quality of
individuals that have made us so strong. Gail’s leadership skills
have helped build and operate
our outpatient services in obstetrics. Perhaps more importantly,
Gail exemplifies a part of the special glue that makes us the
family that we are. It is that ‘family’ oriented culture that
contributes so much to separating us from the others. For so many
years and in so many ways, we have Gail to thank for that.
Gail has mentored medical students, residents, faculty and even
chairs. I have been in each of these roles. She has trained and
represented a role model for innumerable nurses and nursing leaders
within our department. Most importantly to me, she has been a
dependable friend throughout my career. She knew my needs and was
always ready to help in any way she could, and I forever will be
grateful for that help.
Please join me in thanking Gail for her enormous contributions
to all of us. We celebrate her 48-years at UAB and wish her all of
the best as she enjoys some well-deserved rest and relaxation.
Gail has had a hand in everything OB in the department. Not only
has she touched the lives of so many faculty and staff, but she
also has touched the lives of literally thousands of patients for
generations. She will forever be an icon in this department. She
will be sorely missed, but never forgotten.
Kindest Regards,
Bill Andrews
Celebrating 48 years of service at UAB
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BIOBANKS/TISSUE STUDIES, etc.
As part of the Division of GYN Oncology, our Biobanks are housed
in the Arend lab – our goal is to bank tissue and blood for
patients with ovarian cancer, carcinosarcomas, and cervical
cancer.
GYN ONC OPEN TRIALS
GOG279 – Phase II trial with treatment of radiation therapy,
cisplatin, and gemcitabine hydrochloride in patients with locally
advanced squamous cell carcinoma of the vulva. Includes surgical
evaluation of lymph nodes.
Vulvar Cancer
Exemestane study UAB1788– Window of opportunity study with
treatment of Exemestane for 3 weeks prior to hysterectomy in
patients with CAH or G1/2 endometrioid endometrial
adenocarcinoma.
CAH OR G1/G2 Endometrial Cancer
NRG GY017 – Phase I trial with treatment of Atezolizumab before
and/or with chemoradiotherapy in patients with PA node positive
stage IB2, II, IIIB, or IVA primary cervical cancer.NRG GY006 –
Phase III trial with treatment of radiation therapy with cisplatin
alone or in combination with Triapine in women with stage IB2, II,
IIIB, or IVA primary cervical cancer or stage II-IVA vaginal
cancer.UAB1544 – Pilot study with treatment of the TA-CIN vaccine
in patients who have undergone definitive therapy for cervical
cancer in the past 12 months.
Cervical Cancer
UAB1753 – Phase III trial with treatment of metformin in
conjunction with chemotherapy followed by metformin maintenance
therapy in advanced stage ovarian, fallopian tube, and primary
peritoneal cancer in the adjuvant or neoadjuvant setting.OVATION2
study UAB1839– Phase Ib/II trial with treatment of GEN-1 in the
neoadjuvant setting for advanced stage ovarian, fallopian tube, and
primary peritoneal cancer.NRG GY005 – Phase II/III trial with
treatment of Cedaranib v. Cedi/Olaparib v. non-platinum
chemotherapy in patients with recurrent platinum resistant or
refractory high grade serous or endometrioid ovarian cancer (other
histologies may receive if they have a documented germline BRCA
mutation).
Ovarian Cancer
IMPROVE - A study for post menopausal woman who is not currently
using estrogen as a medication or has chosen to stop your current
estrogen therapy for a period of 1 month and is planning surgery to
repair pelvic organ prolapse.PI: Holly RichterInclusion:- Vaginal
bulge by exam with bothersome symptoms.- 48 years of age or older
and have transitioned through menopause (or have had ovaries
surgically removed in the past)- Willing to randomize to use/apply
estrogen cream or a look-alike inactive cream (placebo) for about 6
wks before surgery and then for the first year after their surgery-
Patients who desire surgical treatment for prolapse
POWeR - A study is for Post menopausal women (ages ≥ 55 years)
with or without UI Undergoing an osteoporosis evaluation (DXA and
TBS) PI: Isuzu MeyerInclusion: - Female age 55 or older who has not
had a DEXA scan in the past 10 years.
UroGyn Studies at TKC & WICFor more info, please leave a
message at: 205-934-5498 or email us at:
[email protected]
Allergan - A study for women with refractory urgency urinary
incontinence. This is a Phase 2 randomized dose finding trial where
either placebo, 100U, 200U, 300U or 500U botox are mixed in a
hydrogel and instilled into the bladder with a catheter in the
office.PI: Holly RichterInclusion:-Ages 18-75-Symptoms of
overactive bladder including frequency, urgency and urgency urinary
incontinence-Previously tried medications and had inadequate
response or intolerable side effects-Weight ≥40 kg (88 pounds)
Renovia 17-Fl - A NON-INVASIVE (IN-HOME EXERCISES) study for
fecal incontinence (FI). Fecal incontinence defined as any
uncontrolled loss of liquid or solid fecal material that occurs at
least monthly over the last 3 months that is bothersome enough to
desire treatment.PI: Holly RichterInclusion:- Patients with fecal
incontinence or bowel leakage- Female and 18 years of age and
olderIMPLORE - Investigation of Microbiomes of Postmenopausal Women
Looking for Outcomes and Response to Estrogen Therapy in
postmenopausal women with vulvovaginal atrophyPI: Kyle
NorrisInclusion:- Age ≥55 years old and a screening vaginal pH of
≥5. - Without menses for ≥12 months. - No uterovaginal or vaginal
vault prolapse beyond the hymen.
UAB1824 – Phase I trial with treatment of SY-1365 (a CDK7
inhibitor) in patients with recurrent platinum sensitive or
resistant ovarian cancer. If the histology is not clear cell,
carboplatin is added to the regimen.
PUMA study UAB1839– Phase II trial with treatment of Neratinib
in patients with recurrent ovarian or cervical cancer with
documented ERBB2/3/4 mutations or EGFR amplifications.
UAB1861 – Phase Ib/II trial with treatment of Rebastinib (TIE2
inhibitor) in combination with paclitaxel in patients with
recurrent ovarian cancer or recurrent/metastatic/high risk
endometrial cancer.
UAB17105 – Phase II trial with treatment of DKN-01 (a WNT
modulator) +/- weekly paclitaxel in patients with recurrent ovarian
or uterine carcinosarcoma.
GARNET – UAB1659- Phase I trial with treatment of TSR-042 in
patients with recurrent MSI-H cancers (endometrial, ovarian,
cervix, sarcomas). Cannot enroll until October with the allowance
for slide submission is amended. Current requirement is blocks.
Other
DETECT – A study for women undergoing hysterectomy for reasons
other than ovarian or cervical cancer where a tampon is placed
preoperatively to evaluate for the presence of endometrial cancer
in the tampons.
@UAB_CWRHFollow us on Twitter
For more info, please leave a message at: 205-934-6454 or email
Anna Wilbanks, MSN, RN, WHNP-BC [email protected]
UAB Center for Clinical and Translational Science (CCTS): The
CCTS is a major national initiative that aims to catalyze the
translation of fundamental and clinical research into improvements
for human health and health care delivery. By developing a diverse,
well-trained workforce in translational science, by promoting an
efficient scientific infrastructure, by engaging our communities in
partnership to identify challenges and create approaches to
solutions, and by assuring effective use of available resources,
the CCTS Partner Network accelerates the pace of discovery to
delivery across the entire translational spectrum. We encourage all
faculty, trainees and staff to bookmark the CCTS website – there is
something for everyone! Free resources include: Funding
Opportunities, Grant Review Panels, Drop-in clinics (Stats/Epi),
Grant Samples Library, Protocol Development, Regulatory Support,
Academic Writing, Avoiding Burnout, UAB Promotion and Tenure,
Mentoring, etc. https://www.uab.edu/ccts/
mailto:[email protected]://twitter.com/@UAB_CWRHmailto:[email protected]
https://www.uab.edu/ccts/
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For more info, please contact us at:
[email protected]
Inclusion: - 18-45- Singleton- 10-20.6 weeks
- On insulin or willing to start- Willing to stop their oral
agent and be on ours
MOMPOD-Medical Optimization & Mgmt of Preg. w/Overt Type II
Diabetes PI: Lorie Harper
Inclusion: - Singleton pregnancy- GA 16.0-23.6 wks
- CL on TVUS 20.0mm or less- No h/o spontaneous PTB
TOPS - RCT of Pessary in Singleton Pregnancies with a Short
Cervix PI: Lorie Harper
Inclusion: - Twin gestation - GA 16.0-23.6 wks - CL on TVUS
or=500, C/S >or= 100-1500, with failed 1st line uterotonic &
massage
LIGASSURE - Compare the technical feasibility and surgical
outcomes between complete salpingectomy performed with Ligasure vs
previously performed during the SCORE trialPI: Akila
SubramaniamInclusion: ≥ 25, OBCC patients desiring permanent
sterilization & undergoing c/sectionHPV - Exploratory
study-rates of vaccination uptake in Postpartum patientsPI: Haller
SmithInclusion: 16-26 y/o, postpartum day 1-4, vaginal or c/s,
received PNC at OBCC or a Jefferson County HDMicrobiology Cord
Blood - Investigating the way the environment affects certain
immune cells, called B cellsPI: Rodney KingInclusion: 19 or older,
> or=37 weeks GA, English speakingE-ALPS - RCT (maternal blood
glucose screening with treatment of hyperglycemia with insulin vs
usual care with no CBG screening or treatment) to determine if
keeping mom’s blood sugar normal during labor will help to prevent
the baby from developing low blood sugar after birth.PI: Ashley
Battarbee Inclusion: singleton pregnant women who received 1st dose
of BMZ at 34.0 to 36.5 GA or who have already received BMZ within 6
hours of randomization, expected preterm delivery by any of
following: ROM, PTL, maternal or fetal indications. Delivery
expected in no less than 12 hours and no more than 7 days.
Sickle Cell Study - Maternal/cord blood collection studyPI:
Akila SubramaniamInclusion: 14 or older with at least one S gene.
AS, ASF, SCF, SFA, SS
SAVVY- Pfizer RSV vaccine studyPI: Dr. Alan TitaInclusion: -
Women 18-49 y/o with an uncomplicated singleton pregnancy - 24.0 to
36.0 weeks gestation at time of vaccineRecruitment ends
10-31-2019
• 2 or more major congenital anomalies• 1 major and 2+ minor
anomalies• 1 major anomaly & unexplained major medical
condition
• 1 major anomaly & 1st degree rel w/ same anomaly• OR
suspicion of a potential underlying genetic condition
SouthSeq: Whole Genome Sequencing (WGS) for 1500 live-born
infants with multiple congenital anomalies. Clinical trial arm will
compare return of WGS results by non-genetics providers vs genetics
providers, in order to facilitate deliberative process to develop
guidelines for future implementation of WGS testing in neonates.
Patients may be approached during prenatal visits or immediate
postpartum period.PI: Akila SubramaniamInclusion:
mailto:MFMResearchRecruit%40uabmc.edu?subject=
