Clinical Research Involving Pregnant Women

Acknowledgments -- Contents -- About the Authors -- Chapter 1: Missed Trials, Future Opportunities -- 1.1 Routine Exclusion Is Harmful -- 1.2 Routine Exclusion Is Unfair -- 1.3 Routine Exclusion Is Illogical -- 1.4 The Book -- References -- Part I -- Chapter 2: Why Physicians and Women Should Want Pregnant Women Included in Clinical Trials -- 2.1 Why Are Clinical Trials in Pregnancy Important from a Physician's Perspective? -- 2.2 Why Are Clinical Trials in Pregnancy Important from a Pregnant Woman's Perspective? -- 2.3 Why Might Pregnant Women Not Want to Participate in Clinical Trials? -- 2.4 How Might Pregnant Women Be Encouraged to Participate in Clinical Trials? -- 2.5 Conclusion -- References -- Chapter 3: Better Safe Than Sorry: Risk, Stigma, and Research During Pregnancy -- 3.1 Thalidomide -- 3.2 DES -- 3.3 Regulation -- 3.4 Risk -- 3.5 Stigma -- 3.6 Risk Communication -- 3.7 Conclusion -- References -- Chapter 4: Presumptive Inclusion and Legitimate Exclusion Criteria -- 4.1 Background Assumptions -- 4.2 The Default Position -- 4.3 Criteria Relevant for Exclusion Decisions -- Individualised Review -- Nature and Severity of the Disease -- Previous Nonclinical Data on Animals and Results from Clinical Data -- Availability of Alternative Therapy -- Stage of Pregnancy in Relation to Overall Development of the Foetus -- Risks to the Pregnant Woman, the Foetus, or Child -- Choice to Continue or Terminate the Pregnancy -- Risks to the Individual Pregnant Woman of Not Participating in Clinical Research -- Likelihood That the Intervention Will Be Used by Pregnant Women Even Without Research Evidence -- 4.4 Conclusion -- References -- Part II -- Chapter 5: Fair Inclusion of Pregnant Women in Clinical Research: A Systematic Review of Reported Reasons for Exclusion -- 5.1 Design -- Search Strategy -- Study Selection and Inclusion Criteria