[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42016-42018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16667]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Agency for Healthcare Research and Quality


Scientific Information Request on Management of Postpartum 
Hemorrhage

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information 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 of Management of 
Postpartum Hemorrhage, which is currently being conducted by the 
Evidence-based Practice Centers for the AHRQ Effective Health Care 
Program. Access to

[[Page 42017]]

published and unpublished pertinent scientific information will improve 
the quality of this review. AHRQ is conducting this systematic review 
pursuant to Section 1013 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003, Public Law 108-173, and 
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before August 18, 2014.

ADDRESSES:
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.
    Email submissions: src.org">SIPS@epc-src.org.

Print Submissions

Mailing Address

Portland VA Research Foundation, Scientific Resource Center, ATTN: 
Scientific Information Packet Coordinator, P.O. Box 69539, Portland, OR 
97239.

Shipping Address (FedEx, UPS, etc.)

Portland VA Research Foundation, Scientific Resource Center, ATTN: 
Scientific Information Packet Coordinator, 3710 SW U.S. Veterans 
Hospital Road, Mail Code: R&D 71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna,Telephone: 503-220-8262 
ext. 58653 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: AHRQ has commissioned the Effective Health 
Care (EHC) Program Evidence-based Practice Centers to complete a review 
of the evidence for Management of Postpartum Hemorrhage.
    The EHC 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 Management of Postpartum Hemorrhage, including those 
that describe adverse events. The entire research protocol, including 
the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1918.
    This notice is to notify the public that the EHC program would find 
the following information on Management of Postpartum Hemorrhage 
helpful:
     A list of completed studies that your company has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
     For completed studies that do not have results on 
ClinicalTrials.gov, please provide 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.
     A list of ongoing studies that your company 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.
     Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your company for this 
indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EHC Program. Since 
the contents of all submissions will be made available to the public 
upon request, materials submitted must be publicly available or can 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 EHC 
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 EHC program Web 
site 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: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    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. The entire research 
protocol, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1918.

The Key Questions (KQ)

    KQ1. What is the evidence for the comparative effectiveness of 
interventions for management of postpartum hemorrhage?
    a. What is the comparative effectiveness of interventions intended 
to treat postpartum hemorrhage likely due to atony?
    b. What is the comparative effectiveness of interventions intended 
to treat postpartum hemorrhage likely due to retained placenta?
    c. What is the comparative effectiveness of interventions intended 
to treat postpartum hemorrhage likely due to genital tract trauma?
    d. What is the comparative effectiveness of interventions intended 
to treat postpartum hemorrhage likely due to uncommon causes (e.g., 
coagulopathies, uterine inversion, subinvolution)?
    KQ2.What is the evidence for choosing one intervention over another 
and when to proceed to subsequent interventions for management of 
postpartum hemorrhage?
    KQ3. What are the comparative harms, including adverse events, 
associated with interventions for management of postpartum hemorrhage?
    KQ4. What is the comparative effectiveness of interventions to 
treat acute blood loss anemia after stabilization of postpartum 
hemorrhage?
    KQ5. What systems-level interventions are effective in improving 
management of postpartum hemorrhage?

PICOTS (Population, Intervention, Comparator, Outcomes, Timing, and 
Setting)

Population

     KQ1-3: Women with postpartum hemorrhage (PPH) immediately 
post-birth to 12 weeks postpartum following pregnancy >24 weeks 
gestation.
 KQ4: Women with stabilized PPH and acute blood loss anemia
 KQ 1-5: All modes of birth

Intervention(s)

 KQ1-3, 5
    [cir] Compression techniques (external uterine massage, bimanual 
compression, aortic compression)
    [cir] Medications (oxytocin [Pitocin], prostaglandin El 
[Misoprostol, Cytotec], methylergonovine [Methergine], prostaglandin 
15-methyl F2a [Hemabate], prostaglandin E2 [Dinoprostone], recombinant 
factor Vila [NovoSeven], and tranexamic acid [Cyklokapron])

[[Page 42018]]

    [cir] Devices (Bakri postpartum balloon, Foley catheter, 
Sengstaken-Blakemore tube, Rusch balloon)
    [cir] Procedures (manual removal of placenta, manual evacuation of 
clot, uterine tamponade, uterine artery embolization, laceration 
repair)
    [cir] Surgeries (curettage, uterine artery ligation, uterine 
hemostatic compression suturing, hysterectomy)
    [cir] Blood and fluid products
    [cir] Anti-shock garment
    [cir] Systems-level interventions (e.g., implementation of 
protocols, training)
 KQ4
    [cir] Interventions for acute blood loss anemia (e.g., iron 
replacement, erythropoietin)

Comparator

 Different intervention (any intervention compared with any 
other intervention)
 Placebo

Outcomes

 Intermediate outcomes
    [cir] Blood loss
    [cir] Transfusion
    [cir] ICU admission
    [cir] Anemia
    [cir] Length of stay
 Final outcomes
    [cir] Mortality
    [cir] Uterine preservation
    [cir] Future fertility
    [cir] Breastfeeding
    [cir] Psychological impact
    [cir] Harms

Timing

 Immediately post-birth to 12 weeks postpartum
 Primary (< 24 hours postpartum) or secondary (>= 24 hours 
postpartum)

Setting

    All birth settings (hospital, birth center, home)

    Dated: July 1, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-16667 Filed 7-17-14; 8:45 am]
BILLING CODE 4160-90-P