Phase 2 N=102 Influenza Vaccine in Pregnant Women
Influenza
Primary: Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009…
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N/A N=12,760 Increasing Influenza and Tdap Vaccination of Pregnant Women
Immunization; Infection · Pregnancy Related
Primary: Rate of Influenza Vaccination — 2382; 2496 participants
Phase 2 N=120 H1N1 Vaccine in Pregnant Women
Influenza
Primary: Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination — 15; 21; 26; 37 Participants
Phase 2 N=84 Novartis H1N1 Vaccine in Pregnant Women
Influenza
Primary: Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery — 0; 0; 0; 0 participants
Phase 2 N=370 S. Japonicum and Pregnancy Outcomes
Schistosomiasis
Primary: Mean Newborn Birth Weight — 2.85; 2.85 kilograms — p=0.988
N/A N=70 Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Obesity · Weight Gain, Maternal
Primary: Percent Change in Body Weight — 10.9; 9.6 percentage change
N/A N=2 Safety of 4CMenB Exposure During Pregnancy
Infections, Meningococcal
Primary: Major Congenital Malformation (MCM)
N/A N=360 Participate While Pregnant Survey
Pregnancy
Primary: Willingness to Participate in Research While Pregnant — 319; 39; 288; 70 Participants
N/A N=1,195 Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
HIV-I Infection
Primary: Participants Initiating Pre-exposure Prophylaxis During Pregnancy — 1089 Participants
Phase 2 N=128 Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
HIV Infections · H1N1 Influenza Virus
Primary: The Number of Participants Who Had at Least One Adverse Event (AE) — 118; 11; 8; 0 Participants
Phase 3 N=348 To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
SARS-CoV-2 Infection · COVID-19 · Maternal Immunization
Primary: Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1 — 2.5; 0.6; 0.6; 0 Percentage of participants
N/A N=117 Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy
Anxiety
Primary: Peripheral Markers of Inflammation — 17.09; 20.22; 14.79; 11.78 pg/ml
Phase 4 N=687 Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Primary: Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples…
Phase 4 N=384 Safety of RIV4 Versus IIV4 in Pregnant Women
Safety · Adverse Event Following Immunisation · Birth Outcomes
Primary: Number of Pregnant Women Vaccinated With RIV4 Versus IIV4 With Adverse Birth Outcomes — 17; 21 Participants — p=<0.0001
Phase 4 N=81 Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
Pregnancy
Primary: Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration — 47.5; 48.6; 37.5; 45.9 percentage of participants
Phase 2 N=183 2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
Influenza
Primary: Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events — 2; 3; 2; 0 participants
Phase 3 N=4 ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
Infection, Human Immunodeficiency Virus · HIV Infections · Arthralgia
Primary: Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir — 55.045; 42.473; 78.917 Micrograms*hours per…
N/A N=360 Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Maternal Obesity · Gestational Weight Gain · Obstetric Complications
Primary: Cesarean Section
Phase 4 N=14 Effects of Pregnancy-associated Hormones on THC Metabolism in Women
Pregnancy Related · Cannabis Use
Primary: Dronabinol Exposure — 7.0; 5.6; 5.1; 5.0 nM*h — p=>0.05
N/A N=6,894 Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
COVID-19 · Pregnancy Complications · Mental Health Wellness 1
Primary: Number of Participants With Symptoms of Post-traumatic Stress Disorder — 1028; 532 Participants
N/A N=118 Weight Management for Improved Pregnancy Outcomes
Obesity · Pregnancy
Primary: Maternal Weight Change — 1.2; -2.6 kg
N/A N=41 Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Gestational Weight Gain · Diet, Healthy
Primary: Diet Adherence Assessment Scores Continuous — 9.0; 11 score on a scale
Phase 4 N=956 Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
HIV Infections · Tuberculosis
Primary: Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment — 15.03; 14.93 events per…
N/A N=30 The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women
Physical Activity
Primary: Physical Activity Monitor Measured Steps — 1166.6; 1062.6; 1092.1; 804.3 step
Phase 2 N=129 Placebo-controlled Trial of Bupropion for Smoking Cessation in Pregnant Women
Smoking · Nicotine Dependence
Primary: Number of Participants With Cessation Success at Week 10 After Target Quit Date — 12; 7 Participants with cessation success
N/A N=16 Acute Exercise Effects in Obese Pregnancy
Pregnancy Complications · Obesity · Pre-Eclampsia
Primary: Oral Glucose Insulin Sensitivity (OGIS) Index — 405.0; 426.0; 418.9 uU/mL
Phase 2 N=50 Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women
Tuberculosis
Primary: Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK — 1.4; 1.50 L/hr
Phase 2 N=100 How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women
Postoperative Nausea
Primary: Volume of Distribution Estimated Pharmacokinetic Parameter — 27.9; NA Liters — p=<0.05
Phase 1 N=7 Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
HIV Infections · Pregnancy Related
Primary: Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy — 1340; 928; 1060; 252 ng/mL — p=0.400
Phase 2 N=399 Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
Clostridium Difficile Immunisation · Diphtheria · Diphtheria Immunisation
Primary: Number of Pregnant Women Reporting Related Serious Adverse Events (SAEs) and Unrelated SAEs — 0; 0; 20; 10 Participants