Clinical trials: Maternal Complication of Pregnancy
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Pregnancy, Hyperlipidemias
Bempedoic Acid Pregnancy Surveillance Program
Bempedoic acid pregnancy surveillance program
- Trial name
- NCT05103254
- Testing
- Bempedoic Acid, Bempedoic Acid / Ezetimibe
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Esperion Therapeutics, Inc.
Pregnancy Related, Mental Health Issue
MamaConecta: Digital Tool for Maternal Mental Health
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period.
- Conditions
- Pregnancy Related, Mental Health Issue, Postpartum Depression, Postpartum Anxiety
- Trial name
- DDT (NCT06442774)
- Testing
- Mobile application, Monitoring via wearable
- Where
- 3 sites in Spain
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- A Thousand Colibris, S.L
Infertility, Female
Preimplantation Genetic Testing in Women of Advanced Maternal Age
The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40…
- Trial name
- GETSET (NCT04167748)
- Testing
- Preimplantation genetic testing for aneuploidy (PGT-A)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Genomic Prediction Inc.
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, Inc.
Pre-eclampsia, Preterm Birth
Maternal Serum Markers Predicting Preeclampsia At Early Gestations
This observational study aims to assess the effectiveness of a maternal blood test as a prognostic tool for predicting early pregnancy risk of preeclampsia (PE).
- Trial name
- NCT05131282
- Testing
- Blood test of PE risk, Blood test of Preterm PE risk
- Where
- 6 sites in China
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Early Pregnancy, Early Pregnancy Loss
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
EARLY-PREG is an open-cohort clinical study with a preconception, longitudinal, bidirectional and counterfactual design. The aim of this cohort is to investigate the proteomic signatures of maternal-embryonic communication by…
- Conditions
- Early Pregnancy, Early Pregnancy Loss, Childbirth, Healthy
- Trial name
- EARLY-PREG (NCT07358026)
- Testing
- EMBRYO EXPOSURE
- Where
- Chile
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- MELISA Institute Genomics & Proteomics Research SpA
Sexually Transmitted Diseases
Prospective Registry of Exposure to Gepotidacin (PREG)
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital…
- Trial name
- NCT07850141
- Testing
- None (Observational study)
- Volunteers
- 614 people
- Sponsor
- GlaxoSmithKline
Breast Pain
L.Fermentum CECT5716 in Treatment of Breast Pain
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women…
- Trial name
- NCT02093338
- Testing
- Lactobacillus fermentum CECT5716
- Where
- Spain
- Volunteers
- 127 people
- Sponsor
- Biosearch S.A.
Trisomy 13, Trisomy 18
High Risk Multiple Gestation Study
The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample.
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities
- Trial name
- NCT02278874
- Where
- 4 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Pregnancy
Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome
PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta. Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention.
- Trial name
- PIFBlood1 (NCT01805102)
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 500 people
- Sponsor
- BioIncept LLC
Preterm Birth
Predictive Value of Maternal Blood Protein Signatures in Preterm Birth
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial…
- Trial name
- NCT06664554
- Where
- 5 sites in China
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Maternal sepsIs
Selective Lipopolysaccharide Hemosorption in Maternal Sepsis
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. The prevalence and frequency of obstetric sepsis are quite pronounced.
- Trial name
- MINERVA (NCT05711901)
- Testing
- Efferon LPS
- Where
- 7 sites in Russia
- Volunteers
- 30 people
- Sponsor
- Efferon JSC
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18)
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
- Conditions
- Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome
- Trial name
- NCT00770458
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sequenom, Inc.
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical