Phase 3 N=127 Fetal and Infant Effects of Maternal Buprenorphine Treatment
Neonatal Abstinence Syndrome
Primary: Fetal Heart Rate — 145.7; 143.3; 138.6; 136.3 beats per minute — p=0.001
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=2 Safety of 4CMenB Exposure During Pregnancy
Infections, Meningococcal
Primary: Major Congenital Malformation (MCM)
N/A N=98 Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Emergency Contraception
Primary: Number of Participants Who Experienced Assessed Pregnancy Outcomes — 1; 0; 1; 0 Participants
N/A N=36 Rebif® Pregnancy Registry
Multiple Sclerosis
Primary: Spontaneous Abortion — 2; 0 Participants
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=103 Twinrix Pregnancy Registry
Hepatitis
Primary: Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period — 0; 0; 0; 0 Pregnancy Outcomes
N/A N=19 Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment
Pregnancy · Drug Abuse
Primary: Fetal Heart Rate — 142.34 beats per minute
N/A N=1,509 Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
Pregnancy · Neonates
Primary: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) — 222; 214 Participants
Phase 4 N=70 A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
Multiple Sclerosis · Clinically Isolated Syndrome
Primary: Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) — 0 percentage of participants
N/A N=305 Boostrix® Pregnancy Registry
Pertussis
Primary: Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy…
N/A N=212 Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Intrauterine Resuscitation
Primary: Umbilical Artery Malondialdehyde — 9.8; 10.2 umol/L
Phase 3 N=4 Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Osteoarthritis · Cancer Pain · Recurrent Low Back Pain
Primary: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age — 38.7; 38.7 cm
N/A N=534 Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
Pregnancy
Primary: Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants — 9.4; 3.5 percentage of participants
N/A N=8 Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Pregnancy · Neonates
Primary: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined — 0.0; 33.3 percentage of participants
N/A N=396 Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
Pregnancy · Neonates
Primary: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) — 23.5; 34.4 Percentage of participants
Phase 2 N=42 Maternal Buprenorphine-naloxone Treatment and the Infant
Maternal Opioid Use Disorder · Opioid Exposed Infant
Primary: Fetal Heart Rate at 24 Weeks — 143.64 beats per minute
N/A N=48 Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Maternal Behavior · Alcohol Drinking · Fetal Conditions
Primary: Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG) — 44 Participants
N/A N=10 Phthalate and Bisphenol Exposure During Minipuberty
Phthalate Exposure · Bisphenol Exposure
Primary: Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples — 0.00; 5.43 Log(Arbitrary Units)
Phase 2 N=47 Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Nutrient Deficiency · Pregnancy Related
Primary: Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant — 12244; 7343 unitless
N/A N=682 Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
Pregnancy · Neonates
Primary: Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) — 37.8…
N/A N=50 Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Pregnancy · Neonates
Primary: Number of Expectant Mothers Experiencing Adverse Events (AEs) — 7; 6 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=80 Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
HIV Infections
Primary: Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component — 965; 1050…
N/A N=39 Fetal and Neonatal Magnetophysiology
Fetal Arrhythmia · Abnormality in Fetal Heart Rate or Rhythm · Long QT Syndrome
Primary: Percentage of Subjects Experiencing Symptoms — 0; 0 Participants
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=40 Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women
Exposure to Herbicides
Primary: Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet — 0.19; 0.17; 0.18; 0.14 ug/L — p=0.17
N/A N=3,416 Lamotrigine Pregnancy Registry (LAM05)
Epilepsy · Bipolar Disorder
Primary: Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy — 31; 4; 1; 0 infants
N/A N=10 Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Tobacco Use Disorder
Primary: Number of Days of Inhaler Use — 26.4 days
Phase 1 N=22 PED NEONAT 20-000599 Fetal Body Composition
IUGR · Gestational Diabetes · Pregnancy Related
Primary: Maternal Visceral Adipose Tissue Volume — 97593; 169626; 96787 mm3
Phase 2 N=5 'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
Hernia · Hernia, Diaphragmatic · Hernia, DIaphragmatic, Congenital
Primary: Proportion of Neonate Survival at Discharge From Hospital — 1; 3 Participants