Pregnancy Related Clinical Trial
Official title:
Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
| Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
| Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
| Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
| Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
| Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
| Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
| Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
| Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
| Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
| Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
| Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
| Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
| Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
| Not yet recruiting |
NCT04960800 -
Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis
|
N/A |