|
proteinuria diagnosed with ≥300 mg of protein on 24 h urine collection OR |
≥0.3 on spot protein:creatinine ratio |
|
|
proteinuria diagnosed with ≥1+ protein on urine dipstick |
|
|
blood pressure cannot be measured OR |
no proteinuria evaluation is available (note diagnosis of preeclampsia with severe |
features does not require proteinuria, see definition below) |
|
|
|
is a clinical syndrome characterized by |
pregnancy ≥20 weeks |
AND |
new onset hypertension (systolic blood pressure ≥140 mmHg and/or diastolic |
blood pressure ≥90 mmHg) sustained on two measurements over a minimum of 1 h |
AND |
At least one of the criteria for severe disease: |
|
|
At least one of the following: |
Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 |
mmHg, which is confirmed after only minutes OR |
Development of severe, persistent headache OR |
Development of visual changes OR |
Eclampsia OR |
New onset thrombocytopenia (platelets <100,000/μL) OR |
New onset unremitting epigastric pain OR |
AST and ALT elevated to twice upper limit of normal OR |
Evidence of liver capsular hematoma or liver rupture (diagnosed on clinical exam or with imaging) OR |
Worsening renal function, as evidenced by serum creatinine level greater than 1.1 mg/dL or a doubling of the serum creatinine (absent other renal disease) or oliguria (<500 cc/24 h) OR |
Pulmonary edema (confirmed on imaging with chest X-ray, or on clinical exam) |
|
|
new onset nausea and vomiting |
|
|
blood pressure cannot be measured |
|
|
|
is a clinical syndrome characterized by |
pregnancy ≥20 weeks |
AND |
new onset hypertension (systolic blood pressure ≥140 mmHg and/or diastolic |
blood pressure ≥90 mmHg) sustained on two measurements over a minimum of 1 h |
WITHOUT |
severe features (see preeclampsia with severe features category) and WITHOUT |
proteinuria |
|
|
no proteinuria (as defined by 24 h urine collection < 300 mg, spot protein:creatinine ratio <0.3) |
|
|
no proteinuria (as defined by urine dipstick negative or trace) |
|
|
blood pressure cannot be measured OR |
no proteinuria evaluation is available |
2.1. Guidelines for data collection, analysis and presentation
As mentioned in the overview paper, the case definition is accompanied by guidelines which are structured according to the steps of conducting a clinical trial, i.e. data collection, analysis and presentation. Neither case definition nor guidelines are intended to guide or establish criteria for management of ill infants, children, or adults. Both were developed to improve data comparability.
2.2. Periodic review
Similar to all Brighton Collaboration case definitions and guidelines, review of the definition with its guidelines is planned on a regular basis (i.e. every three to five years) or more often if needed.
3. Guidelines for data collection, analysis and presentation of the hypertensive disorders of pregnancy, as presented in document
It was the consensus of the Brighton Collaboration Hypertensive Disorders of Pregnancy Working Group to recommend the following guidelines to enable meaningful and standardized collection, analysis, and presentation of information about these conditions. 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 hypertension in pregnancy. 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.
3.1. Data collection
These guidelines represent a desirable standard for the collection of data on availability following immunization to allow for comparability of data, and are recommended as an addition to data collected for the specific study question and setting. The guidelines are not intended to guide the primary reporting of the hypertensive disorders of pregnancy to a surveillance system or study monitor. 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. The Brighton Collaboration has developed guidelines for data collection https://brightoncollaboration.org/public/resources/standards/guidelines.html ; and data collection forms https://brightoncollaboration.org/public/resources/data-collection-forms.html .
Guidelines 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 [27] , and the form for reporting of drug adverse events by the Council for International Organizations of Medical Sciences [28] . These data elements include an identifiable reporter and patient, one or more prior immunisations, and a detailed description of the adverse event, in this case, of a hypertensive disorder of pregnancy following immunization. The additional guidelines have been developed as guidance for the collection of additional information to allow for a more comprehensive understanding of development of the hypertensive disorders of pregnancy following immunization.
3.1.1. Source of information/reporter
For all cases and/or all study participants, as appropriate, the following information should be recorded:
- 1) Date of report.
- 2) Name and contact information of person reporting 2 and/or diagnosing the hypertensive disorder of pregnancy as specified by country-specific data protection law.
- 3) Name and contact information of the investigator responsible for the subject, as applicable.
- 4) Relation to the patient (e.g., immunizer [clinician, nurse], family member [indicate relationship], other).
3.1.2. Vaccinee/control
3.1.2.1. demographics.
- 5) Case/study participant identifiers (e.g. first name initial followed by last name initial) or code (or in accordance with country-specific data protection laws).
- 6) Date of birth, age, and sex.
- 7) For infants: Gestational age and birth weight.
3.1.2.2. Clinical and immunization history
- 8) Past medical history, including hospitalisations, underlying diseases/disorders, pre-immunization signs and symptoms including identification of indicators for, or the absence of, a history of allergy to vaccines, vaccine components or medications; food allergy; allergic rhinitis; eczema; asthma.
- 9) 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.g. immunoglobulins, blood transfusion and immunosuppressants).
- 10) Immunization history (i.e. previous immunisations and any adverse event following immunization (AEFI)), in particular occurrence of a hypertensive disorder in pregnancy after a previous immunization.
3.1.3. Details of the immunization
- 11) Date and time of immunization(s).
- 12) Description of vaccine(s) (name of vaccine, manufacturer, lot number, dose (e.g. 0.25 mL, 0.5 mL, etc.) and number of dose if part of a series of immunisations against the same disease).
- 13) The anatomical sites (including left or right side) of all immunisations (e.g. vaccine A in proximal left lateral thigh, vaccine B in left deltoid).
- 14) Route and method of administration (e.g. intramuscular, intradermal, subcutaneous, and needle-free (including type and size), other injection devices).
- 15) Needle length and gauge.
3.1.4. The adverse event
Specifically document:
- 17) Clinical description of signs and symptoms of the hypertensive disorder of pregnancy, and if there was medical confirmation of the event (i.e. patient seen by physician).
- 18) Date/time of onset, 3 first observation 4 and diagnosis, 5 end of episode 6 and final outcome. 7
- 19) Concurrent signs, symptoms, and diseases.
- 20) Measurement/testing
- • Values and units of routinely measured parameters (e.g. temperature, blood pressure)–in particular those indicating the severity of the event;
- • Method of measurement (e.g. type of thermometer, oral or other route, duration of measurement, etc.);
- • Results of laboratory examinations, surgical and/or pathological findings and diagnoses if present.
- 21) Treatment given for the hypertensive disorder of pregnancy, especially any antihypertensive medication, magnesium sulfate and steroid medications.
- 22) Outcome 7 at last observation.
- 23) Objective clinical evidence supporting classification of the event as “serious”. 8
- 24) Exposures other than the immunization 24 h before and after immunization (e.g. food, environmental) considered potentially relevant to the reported event.
3.1.5. Miscellaneous/general
- 25) The duration of surveillance for the hypertensive disorders of pregnancy should be predefined based on
- • Biologic characteristics of the vaccine e.g. live attenuated versus inactivated component vaccines;
- • Biologic characteristics of the vaccine-targeted disease;
- • Biologic characteristics of the hypertensive disorders of pregnancy including patterns identified in previous trials (e.g. early-phase trials); and
- • Biologic characteristics of the vaccinee (e.g. nutrition, underlying disease like immunodepressing illness).
- 26) The duration of follow-up reported during the surveillance period should be predefined likewise. It should aim to continue to resolution of the event.
- 27) Methods of data collection should be consistent within and between study groups, if applicable.
- 28) Follow-up of cases should attempt to verify and complete the information collected as outlined in data collection guidelines 1–24.
- 29) Investigators of patients with a hypertensive disorder of pregnancy should provide guidance to reporters to optimize the quality and completeness of information provided.
- 30) Reports of hypertensive disorders of pregnancy should be collected throughout the study period regardless of the time elapsed between immunization and the adverse event. If this is not feasible due to the study design, the study periods during which safety data are being collected should be clearly defined.
3.2. Data analysis
The following guidelines represent a desirable standard for analysis of data on the hypertensive disorders of pregnancy to allow for comparability of data, and are recommended as an addition to data analyzed for the specific study question and setting.
- 31) 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.
Event classification in 5 categories 9
Event meets case definition
- 1) Level 1: Criteria as specified in the Hypertensive Disorders of Pregnancy case definition
- 2) Level 2: Criteria as specified in the Hypertensive Disorders of Pregnancy case definition
Event does not meet case definitionAdditional categories for analysis
- 3) Reported hypertensive disorder of pregnancy with insufficient evidence to meet the case definition 10 , 11
- 4) Not a case of a hypertensive disorder of pregnancy
- 32) The interval between immunization and reported hypertensive disorder of pregnancy could be defined as the date/time of immunization to the date/time of onset 3 of the first symptoms and/or signs consistent with the definition. 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:
Subjects with a hypertensive disorder of pregnancy by interval to presentation
Interval* | Number |
<1 week after immunization | |
<1 week <1 month after immunization | |
1 month – <3 months after immunization | |
<3 months – <6 months after immunization | |
Every 3 months increments thereafter through 6 weeks postpartum | |
Total |
- 33) The duration of a possible hypertensive disorder of pregnancy could be analyzed as the interval between the date/time of onset 2 of the first symptoms and/or signs consistent with the definition and the end of episode 6 and/or final outcome. 7 Whatever start and ending are used, they should be used consistently within and across study groups.
- 34) 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.
- 35) The distribution of data (as numerator and denominator data) could be analyzed in predefined increments (e.g. measured values, times), where applicable. Increments specified above should be used. When only a small number of cases is presented, the respective values or time course can be presented individually.
- 36) Data on hypertensive disorders of pregnancy obtained from subjects receiving a vaccine should be compared with those obtained from an appropriately selected and documented control group(s) to assess background rates of hypersensitivity in non-exposed populations, and should be analyzed by study arm and dose where possible, e.g. in prospective clinical trials.
3.3. Data presentation
These guidelines represent a desirable standard for the presentation and publication of data on hypertensive disorders of pregnancy following immunization to allow for comparability of data, and are recommended as an addition to data presented for the specific study question and setting. Additionally, it is recommended to refer to existing general guidelines for the presentation and publication of randomized controlled trials, systematic reviews, and meta-analyses of observational studies in epidemiology (e.g. statements of Consolidated Standards of Reporting Trials (CONSORT), of Improving the quality of reports of meta-analyses of randomized controlled trials (QUORUM), and of Meta-analysis Of Observational Studies in Epidemiology (MOOSE), respectively) [29] , [30] , [31] .
- 37) All reported events of hypertensive disorders of pregnancy should be presented according to the categories listed in guideline 31.
- 38) Data on possible hypertensive disorders of pregnancy should be presented in accordance with data collection guidelines 1–24 and data analysis guidelines 31–36.
- 39) Terms to describe hypertensive disorders of pregnancy such as “low-grade”, “moderate”, “high”, or “significant” are highly subjective, prone to wide interpretation, and should be avoided, unless clearly defined.
- 40) Data should be presented with numerator and denominator (n/N) (and not only in percentages), if available.
Although immunization safety surveillance systems denominator data are usually not readily available, attempts should be made to identify approximate denominators. The source of the denominator data should be reported and calculations of estimates be described (e.g. manufacturer data like total doses distributed, reporting through Ministry of Health, coverage/population based data, etc.).
- 41) The incidence of cases in the study population should be presented and clearly identified as such in the text.
- 42) If the distribution of data is skewed, median and range are usually the more appropriate statistical descriptors than a mean. However, the mean and standard deviation should also be provided.
- 43) Any publication of data on the hypertensive disorders of pregnancy should include a detailed description of the methods used for data collection and analysis as possible. It is essential to specify:
- • The study design;
- • The method, frequency and duration of monitoring for the hypertensive disorders of pregnancy;
- • The trial profile, indicating participant flow during a study including drop-outs and withdrawals to indicate the size and nature of the respective groups under investigation;
- • The type of surveillance (e.g. passive or active surveillance);
- • The characteristics of the surveillance system (e.g. population served, mode of report solicitation);
- • The search strategy in surveillance databases;
- • Comparison group(s), if used for analysis;
- • The instrument of data collection (e.g. standardized questionnaire, diary card, report form);
- • Whether the day of immunization was considered “day one” or “day zero” in the analysis;
- • Whether the date of onset 3 and/or the date of first observation 4 and/or the date of diagnosis 5 was used for analysis; and
- • Use of this case definition for the hypertensive disorders of pregnancy, in the abstract or methods section of a publication. 12
The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant's organization (e.g., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the views of their respective institutions.
Acknowledgements
The authors are grateful for the support and helpful comments provided by the Brighton Collaboration (Jan Bonhoeffer, Jorgen Bauwens) and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process. Finally, we would like to thank the members of the ISPE Special Interest Group in Vaccines (VAX SIG) for the review of, constructive comments on. Brighton Collaboration would like to acknowledge The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) Project, funded by the Bill and Melinda Gates Foundation.
2 If the reporting center is different from the vaccinating center, appropriate and timely communication of the adverse event should occur.
3 The date and/or time of onset is defined as the time post immunization, when the first sign or symptom indicative of a hypertensive disorder of pregnancy occurred. This may only be possible to determine in retrospect.
4 The date and/or time of first observation of the first sign or symptom indicative for a hypertensive disorder of pregnancy can be used if date/time of onset is not known.
5 The date of diagnosis of an episode is the day post immunization when the event met the case definition at any level.
6 The end of an episode is defined as the time the event no longer meets the case definition at the lowest level of the definition.
7 E.g. recovery to pre-immunization health status, spontaneous resolution, therapeutic intervention, persistence of the event, sequelae, death.
8 An AEFI is defined as serious by international standards if it meets one or more of the following criteria: (1) it results in death, (2) is life-threatening, (3) it requires inpatient hospitalization or results in prolongation of existing hospitalization, (4) results in persistent or significant disability/incapacity, (5) is a congenital anomaly/birth defect, (6) is a medically important event or reaction.
9 To determine the appropriate category, the user should first establish, whether a reported event meets the criteria for the lowest applicable level of diagnostic certainty, e.g. Level two. If the lowest applicable level of diagnostic certainty of the definition is met, and there is evidence that the criteria of the next higher level of diagnostic certainty are met, the event should be classified in the next category. This approach should be continued until the highest level of diagnostic certainty for a given event could be determined. Major criteria can be used to satisfy the requirement of minor criteria. If the lowest level of the case definition is not met, it should be ruled out that any of the higher levels of diagnostic certainty are met and the event should be classified in additional categories four or five.
10 If the evidence available for an event is insufficient because information is missing, such an event should be categorized as “Reported hypertensive disorder of pregnancy with insufficient evidence to meet the case definition”.
11 An event does not meet the case definition if investigation reveals a negative finding of a necessary criterion (necessary condition) for diagnosis. Such an event should be rejected and classified as “Not a case of a hypertensive disorder of pregnancy”.
12 Use of this document should preferably be referenced by referring to the respective link on the Brighton Collaboration website ( http://www.brightoncollaboration.org ).
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Surrogate Moms Have Higher Rates of Pregnancy Complications
Key Takeaways
Surrogate mothers have a higher risk of pregnancy complications
They are four times more likely to have complications compared to women who conceive naturally
They also are twice as likely to have complications as women with IVF-aided pregnancies
TUESDAY, Sept. 24, 2024 (HealthDay News) -- Surrogate moms have a higher risk of pregnancy complications than other pregnant women, a new study finds.
About 8% of surrogate mothers developed a severe complication like high blood pressure or serious bleeding during delivery , Canadian researchers report.
By comparison, only 2% of women who conceive naturally and 4% of women who conceive via IVF develop similar complications, researchers found.
This is one of the first large-scale studies to compare outcomes between the three different types of pregnancy, they noted.
“Clinicians involved in the care of individuals and couples who need a gestational carrier to build their family should counsel their patients and the gestational carriers about the potential risk during pregnancy and early postpartum,” said lead researcher Dr. Maria Velez , an adjunct scientist with the Institute for Clinical Evaluative Services in Kingston, Ontario.
For the study, researchers analyzed data on more than 863,000 births in Ontario, Canada, between 2012 and 2021. Nearly 98% of pregnancies involved natural conception, compared with 1.8% conception with IVF and 0.1% a surrogate.
Overall risk of complications is higher for surrogates, researchers found, and surrogates have a specifically higher risk of high blood pressure and bleeding after delivery.
Surrogates were also more likely to have a preterm birth, results show.
The new study was published Sept. 23 in the Annals of Internal Medicine .
Further study is needed to figure out why surrogate moms are at greater risk for complications, researchers said.
“There are guidelines about the eligibility criteria to minimize the risk of pregnancy complications among gestational carriers,” Velez said in an institute news release. “However, these guidelines are not always strictly followed.”
More information
Yale Medicine has more on surrogacy .
SOURCE: Institute for Clinical Evaluative Services, news release, Sept. 23, 2024
What This Means For You
Women with a surrogate pregnancy should be sure to follow proper health care guidelines to reduce their risk of complications.
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All abstracts were screened for possible reports of preeclampsia, eclampsia or hypertension in pregnancy following immunization. Twenty-seven articles with potentially relevant material were reviewed in more detail, in order to identify studies using case definitions or, in their absence, providing clinical descriptions of the case material.
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