About this Research Topic
Promoting healthy pregnancy and birth outcomes is essential in supporting pre-and post-natal health, and in ensuring children survive and thrive during infancy and early childhood.
Therapeutic interventions in pregnancy show enormous potential but are often under-funded and under-researched. Moreover, pregnancy as an exclusion criterion in clinical trials is often the result of applied assumptions regarding safety considerations rather than any in-depth review and analysis. This can ultimately result in interventions being used in pregnancy without rigorous review and evaluation, and can leave pregnant women and their newborn children without the benefits of safe and supportive clinical interventions.
Here, we welcome authors to explore topics around therapeutic interventions in pregnancy, including clinical trial design, review of safety and monitoring, vaccination in pregnancy, and nutrient supplementation in pregnancy. This collection aims to increase awareness of the importance of clinical evaluation in pregnancy, and to examine best practices in clinical trial design, as well as discuss novel interventions recently reported or currently being assessed.
We anticipate this collection being comprised mainly of review or opinion pieces but will aim to include primary research articles where possible.
Sub-topics with example focus areas are outlined below.
Clinical trial design in pregnancy:
• Reviews of the methodology of clinical trials in pregnancy (including novel trial design)
• Inclusion criteria for pregnancy (including review of the importance of inclusion of pregnant individuals in clinical trials, review of safety considerations)
• Methodology to ensure representation of marginalized groups, including spectrum of engagement to co-creation at the community level
Vaccination in pregnancy:
• Review of the importance of vaccination in pregnancy with existing licensed vaccines (e.g. influenza, COVID-19, T-dap), including novel vaccines in pregnancy (e.g. RSV)
• Vaccines as "pathogen-agnostic immune modulatory interventions” to prevent PTB
Nutrient supplementation in pregnancy:
• Review of the status of multivitamin supplementation (access in low resource settings), need to address malnutrition
• Novel work in supplementation in pregnancy (e.g. Calcium, Vitamin D), micronutrients (Omega-3s),
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Conflict of interest statement:
Dr. Chloe Ross McDonald works for Pfizer.
Therapeutic interventions in pregnancy show enormous potential but are often under-funded and under-researched. Moreover, pregnancy as an exclusion criterion in clinical trials is often the result of applied assumptions regarding safety considerations rather than any in-depth review and analysis. This can ultimately result in interventions being used in pregnancy without rigorous review and evaluation, and can leave pregnant women and their newborn children without the benefits of safe and supportive clinical interventions.
Here, we welcome authors to explore topics around therapeutic interventions in pregnancy, including clinical trial design, review of safety and monitoring, vaccination in pregnancy, and nutrient supplementation in pregnancy. This collection aims to increase awareness of the importance of clinical evaluation in pregnancy, and to examine best practices in clinical trial design, as well as discuss novel interventions recently reported or currently being assessed.
We anticipate this collection being comprised mainly of review or opinion pieces but will aim to include primary research articles where possible.
Sub-topics with example focus areas are outlined below.
Clinical trial design in pregnancy:
• Reviews of the methodology of clinical trials in pregnancy (including novel trial design)
• Inclusion criteria for pregnancy (including review of the importance of inclusion of pregnant individuals in clinical trials, review of safety considerations)
• Methodology to ensure representation of marginalized groups, including spectrum of engagement to co-creation at the community level
Vaccination in pregnancy:
• Review of the importance of vaccination in pregnancy with existing licensed vaccines (e.g. influenza, COVID-19, T-dap), including novel vaccines in pregnancy (e.g. RSV)
• Vaccines as "pathogen-agnostic immune modulatory interventions” to prevent PTB
Nutrient supplementation in pregnancy:
• Review of the status of multivitamin supplementation (access in low resource settings), need to address malnutrition
• Novel work in supplementation in pregnancy (e.g. Calcium, Vitamin D), micronutrients (Omega-3s),
---
Conflict of interest statement:
Dr. Chloe Ross McDonald works for Pfizer.
Keywords: Pregnancy, lactation, maternal and children health, clinical trial design, vaccination, nutrition, micronutrient supplementation, breastfeeding, birth outcomes
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
