Supplemental Evidence and Data Request on Cervical Ripening in the Outpatient Setting, 6188-6190 [2020-02058]
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
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[FR Doc. 2020–02111 Filed 2–3–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Cervical Ripening in the
Outpatient Setting
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Cervical Ripening in the Outpatient
Setting, which is currently being
conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
DATES: Submission Deadline on or
before 30 days after date of publication
in the Federal Register.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Cervical Ripening in the
Outpatient Setting. AHRQ is conducting
this systematic review pursuant to
Section 902(a) of the Public Health
Service Act, 42 U.S.C. 299a(a).
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Cervical Ripening in the
Outpatient Setting, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/cervical-ripening/protocol.
This is to notify the public that the
EPC Program would find the following
information on Cervical Ripening in the
Outpatient Setting helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
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trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://www.effective
healthcare.ahrq.gov/email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ1: How do the effectiveness and
harms of cervical ripening (CR) using
prostaglandins compare in the
outpatient vs. inpatient setting?
1a: How do effectiveness and harms
vary by choice of prostaglandin?
1b: Do effectiveness and harms vary
by important patient characteristics
(such as gestational age, parity,
uncomplicated pregnancy, prior
cesarean delivery, etc.)?
KQ2: How do the effectiveness and
harms of CR using mechanical methods
(e.g., balloon catheters) compare in the
outpatient vs. inpatient setting?
2a: How do effectiveness and harms
vary by choice of mechanical method in
the inpatient versus the outpatient
setting?
2b: Do effectiveness and harms vary
by important patient characteristics
(such as gestational age, parity,
uncomplicated pregnancy, prior
cesarean delivery, etc.)?
KQ3: How do the effectiveness and
harms of CR in the outpatient setting
vary by method of CR compared with
each other?
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
3a: Do effectiveness and harms vary
by important patient characteristics
(such as gestational age, parity,
uncomplicated pregnancy, prior
cesarean delivery, etc.)?
KQ4: How do the effectiveness and
harms of different methods and
protocols for fetal surveillance compare
with each other or with no monitoring
in pregnant women undergoing CR with
prostaglandins?
4a. Do effectiveness and harms vary
by important patient characteristics
(such as gestational age, parity,
uncomplicated pregnancy, prior
cesarean delivery, etc.)?
Contextual Question: What evidence
informs preference for or tolerability of
different methods of CR in the
outpatient setting or outpatient
compared to the inpatient setting?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)
Inclusion key question 1:
Prostaglandin inpatient vs. outpatient
Inclusion key question 2: Mechanical method inpatient vs
outpatient
Inclusion key question 3: Outpatient comparison of methods
Inclusion key question 4: Fetal
surveillance
• Pregnant women ≥37 weeks
undergoing CR in the outpatient setting.
• Important maternal subgroups: parity, maternal age,
GBS status, diabetes (pregestational, gestational), hypertension (chronic,
preeclampsia without severe
features, gestational).
• Important fetal subgroups:
fetal growth restriction, gestational age (<39 weeks, 39 to
41 weeks, >41 weeks).
• Pharmacologic agents
(prostaglandins) given in outpatient setting.
• Pregnant women ≥37 weeks
undergoing CR in the outpatient setting.
• Important maternal subgroups: parity, maternal age,
GBS status, diabetes (pregestational, gestational), hypertension (chronic,
preeclampsia without severe
features, gestational).
• Important fetal subgroups:
fetal growth restriction, gestational age (<39 weeks, 39 to
41 weeks, >41 weeks).
• Mechanical methods (balloon
catheters, laminaria tents)
used in outpatient setting.
• Pregnant women ≥37 weeks
undergoing CR in the outpatient setting.
• Important maternal subgroups: parity, maternal age,
GBS status, diabetes (pregestational, gestational), hypertension (chronic,
preeclampsia without severe
features, gestational).
• Important fetal subgroups:
fetal growth restriction, gestational age (<39 weeks, 39 to
41 weeks, >41 weeks).
Mechanical methods (balloon
catheters, laminaria tents) or
pharmacologic agents
(prostaglandins).
• Pregnant women ≥37 weeks
undergoing CR with a
prostaglandin.
• Important maternal subgroups: parity, maternal age,
GBS status, diabetes (pregestational, gestational), hypertension (chronic,
preeclampsia without severe
features, gestational).
• Important fetal subgroups:
fetal growth restriction, gestational age (<39 weeks, 39 to
41 weeks, >41 weeks).
• Any method of fetal surveillance.
Comparator ...............
• Mechanical (i.e., balloon
catheters, luminaria tents)
and/or pharmacologic (i.e.,
prostaglandins) methods in
the inpatient setting.
• Mechanical (i.e., balloon
catheters, luminaria tents)
and/or pharmacologic (i.e.,
prostaglandins) methods in
the inpatient setting.
• Another method of fetal surveillance.
• Another protocol for fetal surveillance with the same
method.
• No monitoring.
Outcomes ..................
Effectiveness (birthrelated).
• Total time admission to vaginal delivery; total L&D length
of stay c.
• Cesarean delivery rate overall c.
• Vaginal delivery within 24
hours.
Failed induction rate, defined
as:
Æ CD in patient at <6cm dilation excluding fetal distress
(labor dystocia, failure to
progress, etc.).
Æ CD in patient at <6 cm dilation for fetal distress.
• Cervical assessment at time
of admission (e.g., latent vs.
active phase, Bishop score,
cervical dilation).
• Time from ROM to delivery ..
• Total time admission to vaginal delivery; total L&D length
of stay c.
• Cesarean delivery rate overall c.
• Vaginal delivery within 24
hours.
Failed induction rate, defined
as:
Æ CD in patient at <6cm dilation excluding fetal distress
(labor dystocia, failure to
progress, etc.).
Æ CD in patient at <6 cm dilation for fetal distress.
• Cervical assessment at time
of admission (e.g., latent vs.
active phase, Bishop score,
cervical dilation).
• Time from ROM to delivery ..
Outcomes ..................
Fetal Harms ...............
• Perinatal Mortality c ...............
• Hypoxic-ischemic c
encephalopathy c.
• Seizure c ................................
• Infection (confirmed sepsis or
pneumonia) c.
• Meconium aspiration syndrome c.
• Birth trauma (e.g., bone fracture, neurologic injury, or retinal hemorrhage) c.
• Intracranial or subgaleal
hemorrhage c.
• Need for respiratory support
within 72 hours after birth.
• Apgar score ≤3 at 5 minutes a.
• Hypotension requiring
vasopressor support.
• Umbilical cord gas <pH 7.0
or 7.10.
• Perinatal Mortality c ...............
• Hypoxic-ischemic c
encephalopathy c.
• Seizure c ................................
• Infection (confirmed sepsis or
pneumonia) c.
• Meconium aspiration syndrome c.
• Birth trauma (e.g., bone fracture, neurologic injury, or retinal hemorrhage) c.
• Intracranial or subgaleal
hemorrhage c.
• Need for respiratory support
within 72 hours after birth.
• Apgar score ≤3 at 5 minutes a.
• Hypotension requiring
vasopressor support.
• Umbilical cord gas <pH 7.0
or 7.10.
• Any comparator including alternative mechanical device
or protocol, alternative pharmacologic agent or dose,
combination mechanical and
pharmacologic, placebo, and
other CR methods excluded
as intervention (e.g., Castor
oil, acupuncture).
• Total time admission to vaginal delivery; total L&D length
of stay c.
• Cesarean delivery rate overall c.
• Vaginal delivery within 24
hours.
Failed induction rate, defined
as:
Æ CD in patient at <6cm dilation excluding fetal distress
(labor dystocia, failure to
progress, etc.).
Æ CD in patient at <6 cm dilation for fetal distress.
• Cervical assessment at time
of admission (e.g., latent vs.
active phase, Bishop score,
cervical dilation).
• Time from ROM to delivery ..
• Breastfeeding b.
• Maternal mood b.
• Mother-baby attachment b.
• Perinatal Mortality c ...............
• Hypoxic-ischemic c
encephalopathy c.
• Seizure c ................................
• Infection (confirmed sepsis or
pneumonia) c.
• Meconium aspiration syndrome c.
• Birth trauma (e.g., bone fracture, neurologic injury, or retinal hemorrhage) c.
• Intracranial or subgaleal
hemorrhage c.
• Need for respiratory support
within 72 hours after birth.
• Apgar score ≤3 at 5 minutes a.
• Hypotension requiring
vasopressor support.
• Umbilical cord gas <pH 7.0
or 7.10.
PICOTS
Population .................
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Intervention ................
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Exclusion
Women with contraindications
to CR in the outpatient setting: a multiple pregnancy,
prior uterine rupture and
breech presentation of the
fetus.
• Catheters not available in the
U.S.
• Pharmacy-compounded
prostaglandin products.
• Other CR methods: Castor
oil, nipple stimulation, membrane stripping, sexual intercourse, acupuncture/pressure, transcutaneous nerve
stimulation, herbal compounds.
• Catheters not available in the
U.S.
• Pharmacy-compounded
prostaglandin products.
• Total time admission to vaginal delivery; total L&D length
of stay c.
• Cesarean delivery rate overall c.
• Vaginal delivery within 24
hours.
Failed induction rate, defined
as:
Æ CD in patient at <6cm dilation excluding fetal distress
(labor dystocia, failure to
progress, etc.).
Æ CD in patient at <6 cm dilation for fetal distress.
• Cervical assessment at time
of admission (e.g., latent vs.
active phase, Bishop score,
cervical dilation).
• Time from ROM to delivery.
Outcomes not listed in inclusion
criteria.
• Perinatal Mortality c ...............
• Hypoxic-ischemic c
encephalopathy c.
• Seizure c.
• Infection (confirmed sepsis or
pneumonia) c.
• Meconium aspiration syndrome c.
• Birth trauma (e.g., bone fracture, neurologic injury, or retinal hemorrhage) c.
• Intracranial or subgaleal
hemorrhage c.
• Need for respiratory support
within 72 hours after birth.
• Apgar score ≤3 at 5 minutes a.
• Hypotension requiring
vasopressor support.
• Umbilical cord gas <pH 7.0
or 7.10.
Outcomes not listed in inclusion
criteria.
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
PICOTS
Outcomes ..................
Maternal Harms .........
Timing ........................
Setting .......................
Study design .............
Inclusion key question 1:
Prostaglandin inpatient vs. outpatient
Inclusion key question 2: Mechanical method inpatient vs
outpatient
Inclusion key question 3: Outpatient comparison of methods
• Hemorrhage requiring transfusion c.
• Postpartum hemorrhage by
mode (vaginal, cesarean) c.
• Uterine infection (i.e.,
choriamnionitis, administration of antibiotics in labor
other than GBS prophylaxis) c.
• Placental abruption, Uterine
rupture.
• Umbilical cord prolapse
• Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
Maternal outcomes ...................
• From CR initiation to within
1-week following delivery.
Infant outcomes
• Immediately following delivery.
• Hemorrhage requiring transfusion c.
• Postpartum hemorrhage by
mode (vaginal, cesarean) c.
• Uterine infection (i.e.,
choriamnionitis, administration of antibiotics in labor
other than GBS prophylaxis) c.
• Placental abruption ...............
• Uterine rupture
• Umbilical cord prolapse
• Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
Maternal outcomes ...................
• From CR initiation to within
1-week following delivery.
Infant outcomes
• Immediately following delivery.
• Inpatient versus outpatient
settings.
• Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insufficient, include large, high
quality cohort studies comparing inpatient and outpatient setting.
• Include high quality cohort
and case-control studies for
harms.
• Inpatient versus outpatient
settings.
• Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insufficient, include large, high
quality cohort studies comparing inpatient and outpatient setting.
• Include high quality cohort
and case-control studies for
harms.
• Hemorrhage requiring transfusion c.
• Postpartum hemorrhage by
mode (vaginal, cesarean) c.
• Uterine infection (i.e.,
choriamnionitis, administration of antibiotics in labor
other than GBS prophylaxis) c.
• Placental abruption, Uterine
rupture.
• Umbilical cord prolapse
• Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
Maternal and additional outcomes (i.e., breastfeeding,
maternal mood, mother-baby
attachment).
• From CR initiation to 1-year
postpartum.
Infant outcomes
• Immediately following delivery.
• Outpatient setting ..................
• Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insufficient, include large, high
quality cohort studies comparing inpatient and outpatient setting.
• Include high quality cohort
and case-control studies for
harms.
Inclusion key question 4: Fetal
surveillance
Exclusion
Outcomes not listed in inclusion
• Hemorrhage requiring transcriteria.
fusion c.
• Postpartum hemorrhage by
c
mode (vaginal, cesarean) .
• Uterine infection (i.e.,
choriamnionitis, administration of antibiotics in labor
other than GBS prophylaxis) c.
• Placental abruption ...............
• Uterine rupture
• Umbilical cord prolapse
• Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
Maternal outcomes ................... KQ 1,2,4: Outcomes occurring
• From CR initiation to within
after 1-week post delivery.
1-week following delivery.
KQ3: Outcomes for
Infant outcomes
breastfeeding, mother-infant
• Immediately following delivattachment, and maternal
ery.
mood occurring after 1 year
post-delivery.
• Inpatient and outpatient settings.
• Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insufficient, include large, high
quality cohort studies comparing inpatient and outpatient setting.
• Include high quality cohort
and case-control studies for
harms.
Case series, pre-post studies,
case reports.
c (Bolded) items indicate Primary Outcomes.
CR = cervical ripening; CD = cesarean delivery; KQ = Key Question; ROM = rupture of membrane; CDC = Centers for Disease Control and Prevention; L&D = labor and delivery; RCTs = randomized controlled trials.
Dated: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
Coordination.’’ In accordance with the
Paperwork Reduction Act, AHRQ
invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be
received by 60 days after date of
publication.
[FR Doc. 2020–02058 Filed 2–3–20; 8:45 am]
BILLING CODE 4160–90–P
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Evaluating the Dissemination and
Implementation of PCOR to Increase
Referral, Enrollment, and Retention
through Automatic Referral to Cardiac
Rehabilitation (CR) with Care
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project
Evaluating the Dissemination and
Implementation of PCOR to Increase
Referral, Enrollment, and Retention
through Automatic Referral to Cardiac
Rehabilitation (CR) With Care
Coordination
The aim of AHRQ’s TAKEheart
project is to (a) raise awareness about
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the benefits of cardiac rehabilitation
(CR) after myocardial infarction or
coronary revascularization, then to (b)
disseminate knowledge about the best
practices to increase referrals to CR,
and, finally, (c) to increase CR uptake.
Currently over two-thirds of eligible
cardiac patients are not referred to CR
despite extensive evidence of its
effectiveness in preventing subsequent
morbidity; national estimates of referral
range from 10–34%. To help improve
CR rates, the Million Hearts® Cardiac
Rehabilitation Collaborative—an
initiative co-led by the Centers for
Disease Control and Prevention (CDC)
and the Centers for Medicare &
Medicaid Services (CMS)—developed a
Cardiac Rehabilitation Change Package
(CRCP) and established a national goal
of 70% participation in CR by 2022 for
eligible patients. Recognizing that
widespread adoption of the CRCP could
help hospitals enhance CR rates, the
CDC turned to AHRQ with a request that
AHRQ consider disseminating and
implementing evidence for CR and
practices that promote CR. The CRCP is
designed to facilitate this dissemination
and implementation process.
AHRQ reviewed this request in the
context of its Patient Centered
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]]>Agencies
[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6188-6190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02058]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Cervical Ripening in
the Outpatient Setting
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Cervical
Ripening in the Outpatient Setting, which is currently being conducted
by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before 30 days after date of
publication in the Federal Register.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Cervical Ripening in
the Outpatient Setting. AHRQ is conducting this systematic review
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C.
299a(a).
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Cervical Ripening in the Outpatient Setting, including
those that describe adverse events. The entire research protocol is
available online at: https://effectivehealthcare.ahrq.gov/products/cervical-ripening/protocol.
This is to notify the public that the EPC Program would find the
following information on Cervical Ripening in the Outpatient Setting
helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ1: How do the effectiveness and harms of cervical ripening (CR)
using prostaglandins compare in the outpatient vs. inpatient setting?
1a: How do effectiveness and harms vary by choice of prostaglandin?
1b: Do effectiveness and harms vary by important patient
characteristics (such as gestational age, parity, uncomplicated
pregnancy, prior cesarean delivery, etc.)?
KQ2: How do the effectiveness and harms of CR using mechanical
methods (e.g., balloon catheters) compare in the outpatient vs.
inpatient setting?
2a: How do effectiveness and harms vary by choice of mechanical
method in the inpatient versus the outpatient setting?
2b: Do effectiveness and harms vary by important patient
characteristics (such as gestational age, parity, uncomplicated
pregnancy, prior cesarean delivery, etc.)?
KQ3: How do the effectiveness and harms of CR in the outpatient
setting vary by method of CR compared with each other?
[[Page 6189]]
3a: Do effectiveness and harms vary by important patient
characteristics (such as gestational age, parity, uncomplicated
pregnancy, prior cesarean delivery, etc.)?
KQ4: How do the effectiveness and harms of different methods and
protocols for fetal surveillance compare with each other or with no
monitoring in pregnant women undergoing CR with prostaglandins?
4a. Do effectiveness and harms vary by important patient
characteristics (such as gestational age, parity, uncomplicated
pregnancy, prior cesarean delivery, etc.)?
Contextual Question: What evidence informs preference for or
tolerability of different methods of CR in the outpatient setting or
outpatient compared to the inpatient setting?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inclusion key question Inclusion key question Inclusion key
1: Prostaglandin 2: Mechanical method question 3: Inclusion key
PICOTS inpatient vs. inpatient vs Outpatient comparison question 4: Fetal Exclusion
outpatient outpatient of methods surveillance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Population......................... Pregnant Pregnant Pregnant Pregnant Women with
women >=37 weeks women >=37 weeks women >=37 weeks women >=37 weeks contraindications to
undergoing CR in the undergoing CR in the undergoing CR in the undergoing CR with a CR in the outpatient
outpatient setting. outpatient setting. outpatient setting. prostaglandin. setting: a multiple
Important Important Important Important pregnancy, prior
maternal subgroups: maternal subgroups: maternal subgroups: maternal subgroups: uterine rupture and
parity, maternal age, parity, maternal age, parity, maternal parity, maternal breech presentation
GBS status, diabetes GBS status, diabetes age, GBS status, age, GBS status, of the fetus.
(pre-gestational, (pre-gestational, diabetes (pre- diabetes (pre-
gestational), gestational), gestational, gestational,
hypertension hypertension gestational), gestational),
(chronic, (chronic, hypertension hypertension
preeclampsia without preeclampsia without (chronic, (chronic,
severe features, severe features, preeclampsia without preeclampsia without
gestational).. gestational).. severe features, severe features,
Important Important gestational).. gestational)..
fetal subgroups: fetal subgroups: Important Important
fetal growth fetal growth fetal subgroups: fetal subgroups:
restriction, restriction, fetal growth fetal growth
gestational age (<39 gestational age (<39 restriction, restriction,
weeks, 39 to 41 weeks, 39 to 41 gestational age (<39 gestational age (<39
weeks, >41 weeks).. weeks, >41 weeks).. weeks, 39 to 41 weeks, 39 to 41
weeks, >41 weeks).. weeks, >41 weeks)..
Intervention....................... Pharmacologic Mechanical Mechanical methods Any method Catheters
agents methods (balloon (balloon catheters, of fetal not available in the
(prostaglandins) catheters, laminaria laminaria tents) or surveillance. U.S.
given in outpatient tents) used in pharmacologic agents Pharmacy-
setting. outpatient setting. (prostaglandins). compounded
prostaglandin
products.
Other CR
methods: Castor oil,
nipple stimulation,
membrane stripping,
sexual intercourse,
acupuncture/
pressure,
transcutaneous nerve
stimulation, herbal
compounds.
Comparator......................... Mechanical Mechanical Any Another Catheters
(i.e., balloon (i.e., balloon comparator including method of fetal not available in the
catheters, luminaria catheters, luminaria alternative surveillance. U.S.
tents) and/or tents) and/or mechanical device or Another Pharmacy-
pharmacologic (i.e., pharmacologic (i.e., protocol, protocol for fetal compounded
prostaglandins) prostaglandins) alternative surveillance with prostaglandin
methods in the methods in the pharmacologic agent the same method.. products.
inpatient setting. inpatient setting. or dose, combination No
mechanical and monitoring..
pharmacologic,
placebo, and other
CR methods excluded
as intervention
(e.g., Castor oil,
acupuncture).
Outcomes........................... Total time Total time Total time Total time Outcomes not listed
Effectiveness (birth-related)...... admission to vaginal admission to vaginal admission to vaginal admission to vaginal in inclusion
delivery; total L&D delivery; total L&D delivery; total L&D delivery; total L&D criteria.
length of stay c. length of stay c. length of stay c. length of stay c.
Cesarean Cesarean Cesarean Cesarean
delivery rate overall delivery rate overall delivery rate delivery rate
c. c. overall c. overall c.
Vaginal Vaginal Vaginal Vaginal
delivery within 24 delivery within 24 delivery within 24 delivery within 24
hours. hours. hours. hours.
Failed induction Failed induction Failed induction Failed induction
rate, defined as: rate, defined as: rate, defined as: rate, defined as:
[cir] CD in patient [cir] CD in patient [cir] CD in patient [cir] CD in patient
at <6cm dilation at <6cm dilation at <6cm dilation at <6cm dilation
excluding fetal excluding fetal excluding fetal excluding fetal
distress (labor distress (labor distress (labor distress (labor
dystocia, failure to dystocia, failure to dystocia, failure to dystocia, failure to
progress, etc.) progress, etc.) progress, etc.) progress, etc.)
[cir] CD in patient [cir] CD in patient [cir] CD in patient [cir] CD in patient
at <6 cm dilation for at <6 cm dilation for at <6 cm dilation for at <6 cm dilation for
fetal distress fetal distress fetal distress fetal distress
Cervical Cervical Cervical Cervical
assessment at time of assessment at time of assessment at time assessment at time
admission (e.g., admission (e.g., of admission (e.g., of admission (e.g.,
latent vs. active latent vs. active latent vs. active latent vs. active
phase, Bishop score, phase, Bishop score, phase, Bishop score, phase, Bishop score,
cervical dilation). cervical dilation). cervical dilation). cervical dilation).
Time from ROM Time from ROM Time from Time from
to delivery. to delivery. ROM to delivery. ROM to delivery.
Breastfeeding b.
Maternal
mood b.
Mother-baby
attachment b.
Outcomes........................... Perinatal Perinatal Perinatal Perinatal Outcomes not listed
Fetal Harms........................ Mortality c. Mortality c. Mortality c. Mortality c. in inclusion
Hypoxic- Hypoxic- Hypoxic- Hypoxic- criteria.
ischemic c ischemic c ischemic c ischemic c
encephalopathy c.. encephalopathy c.. encephalopathy c.. encephalopathy c..
Seizure c.... Seizure c.... Seizure c... Seizure c...
Infection Infection Infection Infection
(confirmed sepsis or (confirmed sepsis or (confirmed sepsis or (confirmed sepsis or
pneumonia) c. pneumonia) c. pneumonia) c. pneumonia) c.
Meconium Meconium Meconium Meconium
aspiration syndrome c. aspiration syndrome c. aspiration syndrome aspiration syndrome
c. c.
Birth trauma Birth trauma Birth trauma Birth trauma
(e.g., bone fracture, (e.g., bone fracture, (e.g., bone (e.g., bone
neurologic injury, or neurologic injury, or fracture, neurologic fracture, neurologic
retinal hemorrhage) c. retinal hemorrhage) c. injury, or retinal injury, or retinal
hemorrhage) c. hemorrhage) c.
Intracranial Intracranial Intracranial Intracranial
or subgaleal or subgaleal or subgaleal or subgaleal
hemorrhage c. hemorrhage c. hemorrhage c. hemorrhage c.
Need for Need for Need for Need for
respiratory support respiratory support respiratory support respiratory support
within 72 hours after within 72 hours after within 72 hours within 72 hours
birth. birth. after birth. after birth.
Apgar score Apgar score Apgar score Apgar score
<=3 at 5 minutes a. <=3 at 5 minutes a. <=3 at 5 minutes a. <=3 at 5 minutes a.
Hypotension Hypotension Hypotension Hypotension
requiring vasopressor requiring vasopressor requiring requiring
support. support. vasopressor support. vasopressor support.
Umbilical Umbilical Umbilical Umbilical
cord gas Hemorrhage Hemorrhage Hemorrhage Hemorrhage Outcomes not listed
Maternal Harms..................... requiring transfusion requiring transfusion requiring requiring in inclusion
c. c. transfusion c. transfusion c. criteria.
Postpartum Postpartum Postpartum Postpartum
hemorrhage by mode hemorrhage by mode hemorrhage by mode hemorrhage by mode
(vaginal, cesarean) (vaginal, cesarean) (vaginal, cesarean) (vaginal, cesarean)
c.. c.. c.. c..
Uterine Uterine Uterine Uterine
infection (i.e., infection (i.e., infection (i.e., infection (i.e.,
choriamnionitis, choriamnionitis, choriamnionitis, choriamnionitis,
administration of administration of administration of administration of
antibiotics in labor antibiotics in labor antibiotics in labor antibiotics in labor
other than GBS other than GBS other than GBS other than GBS
prophylaxis) c. prophylaxis) c. prophylaxis) c. prophylaxis) c.
Placental Placental Placental Placental
abruption, Uterine abruption. abruption, Uterine abruption.
rupture. Uterine rupture. Uterine
Umbilical rupture. Umbilical rupture.
cord prolapse. Umbilical cord prolapse. Umbilical
Duration of cord prolapse. Duration of cord prolapse.
time between hospital Duration of time between Duration of
admission to birth time between hospital hospital admission time between
that is insufficient admission to birth to birth that is hospital admission
to enable complete that is insufficient insufficient to to birth that is
GBS prophylaxis to enable complete enable complete GBS insufficient to
antibiotics GBS prophylaxis prophylaxis enable complete GBS
administration per antibiotics antibiotics prophylaxis
CDC guidelines.. administration per administration per antibiotics
CDC guidelines.. CDC guidelines.. administration per
CDC guidelines..
Timing............................. Maternal outcomes..... Maternal outcomes..... Maternal and Maternal outcomes.... KQ 1,2,4: Outcomes
From CR From CR additional outcomes From CR occurring after 1-
initiation to within initiation to within (i.e., initiation to within week post delivery.
1-week following 1-week following breastfeeding, 1-week following KQ3: Outcomes for
delivery.. delivery.. maternal mood, delivery.. breastfeeding,
Infant outcomes....... Infant outcomes....... mother-baby Infant outcomes...... mother-infant
Immediately Immediately attachment). Immediately attachment, and
following delivery.. following delivery.. From CR following delivery.. maternal mood
initiation to 1-year occurring after 1
postpartum.. year post-delivery.
Infant outcomes......
Immediately
following delivery..
Setting............................ Inpatient Inpatient Outpatient Inpatient
versus outpatient versus outpatient setting. and outpatient
settings. settings. settings.
Study design....................... Randomized Randomized Randomized Randomized Case series, pre-post
Controlled Trials; Controlled Trials; Controlled Trials; Controlled Trials; studies, case
recent high quality recent high quality recent high quality recent high quality reports.
Systematic Reviews; Systematic Reviews; Systematic Reviews; Systematic Reviews;
if RCT evidence for if RCT evidence for if RCT evidence for if RCT evidence for
benefits is benefits is benefits is benefits is
insufficient, include insufficient, include insufficient, insufficient,
large, high quality large, high quality include large, high include large, high
cohort studies cohort studies quality cohort quality cohort
comparing inpatient comparing inpatient studies comparing studies comparing
and outpatient and outpatient inpatient and inpatient and
setting. setting. outpatient setting. outpatient setting.
Include high Include high Include high Include high
quality cohort and quality cohort and quality cohort and quality cohort and
case-control studies case-control studies case-control studies case-control studies
for harms. for harms. for harms. for harms.
--------------------------------------------------------------------------------------------------------------------------------------------------------
c (Bolded) items indicate Primary Outcomes.
CR = cervical ripening; CD = cesarean delivery; KQ = Key Question; ROM = rupture of membrane; CDC = Centers for Disease Control and Prevention; L&D =
labor and delivery; RCTs = randomized controlled trials.
Dated: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-02058 Filed 2-3-20; 8:45 am]
BILLING CODE 4160-90-P
