[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]


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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.

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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published and unpublished pertinent scientific information will improve 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)
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                                     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
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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.
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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