Remarkable progress has been made in the implementation of vaccinations against infectious diseases worldwide. Immunization of pregnant women is important because pregnancy is thought to modulate the immune system to tolerate a growing fetus, and this, along with the physiologic changes of pregnancy, may increase susceptibility to certain infectious diseases . Immunizing the mother also provides direct protection via transplacental transfer of antibodies for the fetus during pregnancy and for the neonate following delivery. Pregnancy outcomes related to the administration of immunizations during pregnancy, however, have been less well studied. Puerperal sepsis is defined by the World Health Organization WHO as infection of the genital tract occurring any time between the rupture of membranes or labor and the 42nd day postpartum. This definition encompasses both chorioamnionitis and postpartum endometritis or endomyometritis PPE , two of the most common infections surrounding childbirth .
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Remarkable progress has been made in the implementation of vaccinations against infectious diseases worldwide. Immunization of pregnant women is important because pregnancy is thought to modulate the immune system to tolerate a growing fetus, and this, along with the physiologic changes of pregnancy, may increase susceptibility to certain infectious diseases . Immunizing the mother also provides direct protection via transplacental transfer of antibodies for the fetus during pregnancy and for the neonate following delivery.
Pregnancy outcomes related to the administration of immunizations during pregnancy, however, have been less well studied. Puerperal sepsis is defined by the World Health Organization WHO as infection of the genital tract occurring any time between the rupture of membranes or labor and the 42nd day postpartum.
This definition encompasses both chorioamnionitis and postpartum endometritis or endomyometritis PPE , two of the most common infections surrounding childbirth . These complications are likely to be inconsistently reported. Infection following incomplete or complete abortion, diagnostic levels of certainty 1 and 2. Early identification and appropriate management of these infections is essential for prevention of maternal and infant morbidity and mortality.
Efforts have been made to standardize the definitions for maternal infectious conditions or sepsis in order to improve identification of the condition, facilitating timely treatment based upon prompt identification, and assessment of the burden of maternal puerperal sepsis across settings  , .
While infectious complications following delivery or abortion are important pregnancy outcomes and should be reported in vaccine trials, the variability in terms used and lack of standardized diagnostic criteria make interpretation of available data challenging.
Our aim is to provide guidance for the appropriate diagnosis of postpartum endometritis PPE in studies of maternal vaccination and to improve data quality by harmonizing the definitions, allowing comparability across studies. In addition to PPE, we have also included levels of evidence for diagnostic criteria for septic abortion, since the clinical signs and symptoms and the microbial pathogens are similar to those of PPE .
The distinction between the PPE and septic abortion is frequently based solely upon the gestational age at the time the pregnancy concludes. Chorioamnionitis, or intra-amniotic infection, is discussed in a related article . Infection following childbirth occurs commonly. As with maternal mortality in general, death and morbidity from puerperal sepsis are more common in low-resource settings compared to high-resource settings .
Other common causes of postpartum febrile morbidity include mastitis, urinary tract infection, and abdominal or perineal wound infection. The relative frequency of these infections seems to vary by clinical setting. Mastitis 3—4. A prospective study in Uganda found that endometritis was the most common in-hospital postpartum infection 1. Postpartum endometritis is an infection of the decidua, or uterine lining.
It is typically polymicrobial, involving both facultative and anaerobic bacteria; genital mycoplasmas and sexually transmitted organisms such at C. Group B Streptococcus , frequently found in the genital tracts of pregnant women, is thought to be responsible for a significant number of infections in postpartum women worldwide .
Group A Streptococcus infection, while relatively rare, is associated with a particularly rapid and severe course of postpartum endometritis and with rapidly progressive soft tissue infections .
The most important risk factor for postpartum endometritis is cesarean delivery. This risk is 21 times higher when the cesarean occurs following labor . Postpartum endometritis is a clinical diagnosis, usually defined as maternal pyrexia together with physical signs of endometrial infection. Clinical signs and symptoms usually include fever and one or more of the following:uterine tenderness, abnormal vaginal discharge or odor, and delay in the rate of reduction of size of the uterus .
Other laboratory evidence is often used to support the diagnosis of infection, such as an elevated white blood cell count; an elevated blood lactic acid concentration is useful in identifying hypoperfusion related to sepsis.
While detection of bacteremia with blood cultures can be useful to tailor antibiotic treatment in complicated infections for example, in immunocompromised patients , the polymicrobial nature of most infections limits its utility; thus, in most patients with uncomplicated infection, broad-spectrum antibiotic treatment is recommended and usually effective  , . Abnormal vital signs consistent with sepsis physiology such as elevated or depressed temperature, hypotension, tachycardia, tachypnea or bradypnea, hypoxia, leukocytosis or leukopenia, bandemia excess immature white blood cells , and lactic acidosis can help identify women requiring urgent evaluation and treatment  , .
Endometrial bacterial cultures are challenging to obtain without contamination  and rarely impact treatment decisions; thus they are not routinely performed in most settings . One exception may be Group A Streptococcus , which remains extremely sensitive to penicillin.
Abortion is a common pregnancy outcome. The rate of infection following spontaneous abortion is low. Induced abortion is the termination of pregnancy through medical or surgical procedures. In women in HIC undergoing surgical abortion procedures i. Worldwide, the rate of infection after surgical abortion is 0. Rates of infection related to abortion in LMIC is difficult to ascertain, but given that almost all unsafe abortions occur in developing countries  , this statistic is likely to be higher than in HIC.
Infection following incomplete or complete abortion induced or spontaneous , results from infection of the products of conception retained within the uterine cavity. While most bacteria that cause infection following abortion are genital flora e. Group B streptococcus, B. Uterine instrumentation increases the risk of infection following abortion . Retained products of conception provide a nidus for the development of infection.
Many studies report an increased incidence of post-abortion complications in settings where abortion laws are restrictive  ,  , . Treatment delays are thought to contribute significantly to mortality associated with induced abortion .
As with postpartum endometritis, infection following incomplete or complete abortion is a clinical diagnosis in a patient with an incomplete abortion or following a completed abortion in which there is pyrexia and evidence of uterine tenderness. Peritonitis may be present. Retained products of conception, purulent discharge and vaginal bleeding are common signs associated with the condition. While not required for the diagnosis or prior to treatment, culture data is often obtained; products of conception should be sent for culture and Gram stain, if available .
All abstracts were screened for possible reports of abortion following immunization. Searches were restricted to references in English, and involving only human subjects. Multiple general medical, pediatric, obstetrics and infectious disease textbooks were also searched.
The search and screening resulted in the identification of articles with potentially relevant material for further evaluation. Most publications addressing postpartum endometritis and infection following abortion following immunization were case reports of single cases or case series describing various pregnancy outcomes, for which terminology was very inconsistent and very few used case definitions. Postpartum endomyometritis is a term that is increasingly utilized to describe uterine infection after childbirth in order to highlight that the infection does not solely involve the endometrial layer of the uterus, but also the myometrial, or muscular layer.
It needs to be re-emphasized that the grading of definition levels is entirely concerned with diagnostic certainty, not clinical severity of an event. Thus, a clinically very severe event may appropriately be classified as Level Two or Three rather than Level One if it could reasonably be non-abortion related. Detailed information about the severity of the event should always be recorded, as specified by the data collection guidelines.
Our case definition has been formulated such that the Level One definition is highly specific for the condition. As maximum specificity normally implies a loss of sensitivity, two additional diagnostic levels have been included in the definition, offering a stepwise increase of sensitivity from Level One down to Level Three, while retaining an acceptable level of specificity at each level. In this way it is hoped that all possible cases of post-partum endometritis and infection following incomplete or complete abortion can be captured.
There is a need to consider data sources and availability of existing data when defining pregnancy outcomes in research. The interpretation of data is difficult when definitions of commonly used terms differ in the literature. Sometimes these data are not made available. Proposed algorithms for defining abortion, fever and for estimating gestational age for studies in various settings are presented in related manuscripts  ,  , .
The gestational age used to define second trimester abortion varies widely among resource settings. However, we have chosen to utilize the GAIA project definition of abortion using the Brighton guidelines in order to ensure harmonization across GAIA definitions, resulting in the fewest number of missed cases of post-partum endometritis and infection after complete or incomplete abortion as possible.
We emphasize that this gestational age cut-off should be used for research and data collection purposes only, and is not intended to inform or impact clinical care.
Where feasible, details of this interval should be assessed and reported as described in the data collection guidelines see guideline 34, Section 3.
As mentioned in the overview paper  , the case definition is accompanied by guidelines that are structured according to the steps of conducting a clinical trial, i. Neither case definition nor guidelines are intended to guide or establish criteria for management of ill infants, children, or adults, but were instead developed to improve data comparability.
Similar to all Brighton Collaboration case definitions and guidelines, review of the definition with its guidelines is planned on a regular basis i. It was the consensus of the Brighton Collaboration Postpartum Endometritis and Infection or Sepsis following Complete or Incomplete Abortion Working Group to recommend the following guidelines to enable meaningful and standardized collection, analysis, and presentation of information.
However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographical region, and whether the source of information is a prospective clinical trial, a post-marketing surveillance or epidemiological study, or an individual report of postpartum endometritis or infection following incomplete or complete abortion.
Also, as explained in more detail in the overview paper in this volume, these guidelines have been developed by this working group for guidance only, and are not to be considered a mandatory requirement for data collection, analysis, or presentation.
These guidelines represent a desirable standard for the collection of available pregnancy outcome data following immunization to allow comparability. The guidelines are not intended to guide the primary reporting of abortion to a surveillance system. Investigators developing a data collection tool based on these data collection guidelines also need to refer to the criteria in the case definition, which are not repeated in these guidelines.
Guidelines 1—46 below have been developed to address data elements for the collection of adverse event information as specified in general drug safety guidelines by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [ICHTR doc], and the form for reporting of drug adverse events by the Council for International Organizations of Medical Sciences [CIOMS].
These data elements include an identifiable reporter and patient, one or more prior immunizations, and a detailed description of the adverse event, in this case, of abortion following immunization. The additional guidelines have been developed as guidance for the collection of additional information to allow for a more comprehensive understanding of abortion following immunization.
Name and contact information of person 2 reporting postpartum endometritis or infection following incomplete or complete abortion as specified by country specific data protection law. Relationship of the reporter to the vaccine recipient [e. Case study participant identifiers first name initial followed by last name initial or code or in accordance with country- specific data protection laws. Any medication history other than treatment for the event described prior to, during, and after immunization including prescription and non-prescription medication as well as medication or treatment with long half-life or long term effect e.
Immunization history i. For all cases at any level of diagnostic certainty and for reported events with insufficient evidence, the criteria fulfilled to meet the case definition should be recorded. The following guidelines represent a desirable standard for analysis of data on postpartum endometritis and infection following incomplete or complete abortion to allow for comparability of data, and are recommended as an addition to data analyzed for the specific study question and setting.
Reported events should be classified in one of the following five categories including the three levels of diagnostic certainty. Events that meet the case definition should be classified according to the levels of diagnostic certainty as specified in the case definition. Events that do not meet the case definition should be classified in the additional categories for analysis. Reported abortion with insufficient evidence to meet the case definition Not a case of postpartum endometritis or infection following incomplete or complete abortion If few cases are reported, the concrete time course could be analyzed for each; for a large number of cases, data can be analyzed in the following increments for identification of temporal clusters:.
If more than one measurement of a particular criterion is taken and recorded, the value corresponding to the greatest magnitude of the adverse experience could be used as the basis for analysis.
Analysis may also include other characteristics like qualitative patterns of criteria defining the event.
Puerperal endometritis is uterine infection, typically caused by bacteria ascending from the lower genital or gastrointestinal tract. Symptoms are uterine tenderness, abdominal or pelvic pain, fever, malaise, and sometimes discharge. Diagnosis is clinical, rarely aided by culture. Treatment is with broad-spectrum antibiotics eg, clindamycin plus gentamicin. Endometritis may develop after chorioamnionitis during labor or postpartum.
Post partum infections: A review for the non-OBGYN