Abstract
BackgroundMaternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders.MethodsThe development of a COS for studies on obesity in pregnant patients (COSSOPP) will comprise five steps. First, a systematic review of published literature will identify the long list of outcomes, their definitions and measurements if applicable, and outcome reporting quality. This will be followed by a meta-synthesis of qualitative studies with patients, and qualitative interviews in Toronto with patients, clinicians, researchers, hospital administrators, and policy-makers, to identify novel outcomes that were not obtained through systematic review. Third, the long list of outcomes will be narrowed down through online Delphi surveys involving an international group of patients and relevant stakeholders. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Finally, in order to determine how the identified core outcomes should be measured, we will conduct another literature review and Delphi process.DiscussionCOSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization.COMET Core Outcome Set Registrationhttp://www.comet-initiative.org/studies/details/939.
Highlights
Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events
An estimated 38.3% of women in the USA between the ages of 20–39 years have a body mass index (BMI) ≥ 30 [1], many of whom will plan a pregnancy. Do these women have higher incidences of pre-existing conditions such as diabetes mellitus, chronic hypertension, cardiovascular disease, and mental illness [2, 3], but even in their absence, are at a higher risk of developing pregnancyspecific complications during the antepartum, intrapartum, and postpartum periods
Systematic reviews and meta-analyses of Clinical trial (CT) looking at these interventions repeatedly highlight heterogeneity in outcomes reported between studies, causing difficulty with data aggregation and synthesis [13, 14]
Summary
Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. An estimated 38.3% of women in the USA between the ages of 20–39 years have a body mass index (BMI) ≥ 30 [1], many of whom will plan a pregnancy Do these women have higher incidences of pre-existing conditions such as diabetes mellitus, chronic hypertension, cardiovascular disease, and mental illness [2, 3], but even in their absence, are at a higher risk of developing pregnancyspecific complications during the antepartum (gestational diabetes mellitus, gestational hypertension, preeclampsia, fetal macrosomia, intrauterine growth restriction, congenital anomalies, and stillbirths [4,5,6]), intrapartum (labor dystocia, and failed labor induction or augmentation [7, 8] resulting in higher rates of cesarean and operative vaginal deliveries and birth trauma [9]), and postpartum (wound infections, hemorrhage, thromboembolism, depression, lactation failure, and prolonged hospitalization [5]) periods. International initiatives, such as Core Outcome Measurement in Effectiveness Trials (COMET) and Core Outcomes in Women’s and Newborn Health (CROWN) have addressed the need to develop “core outcome sets” (COS) aimed at standardizing the reporting and measuring of health outcomes in research [15, 16]
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