Clinical trials: Delivery, Obstetric
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Obstetric Labour, Premature
A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
The study's primary objective is to demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo.
- Trial name
- NEWBORN-1 (NCT02377466)
- Testing
- Retosiban IV infusion
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Preeclampsia
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
- Trial name
- SAVE (NCT02923206)
- Testing
- TheraSorb sFlt-1 adsorber
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Miltenyi Biomedicine GmbH
Preterm Labor
PoC Study of OBE022 in Threatened Preterm Labour
This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between…
- Trial name
- PROLONG (NCT03369262)
- Testing
- OBE022, Atosiban
- Where
- 18 sites in Czechia, Finland and 4 more
- Volunteers
- 115 people
- Sponsor
- ObsEva SA
Labor, Premature, Premature Birth
A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
To determine the effects of four different single bolus doses of FE200440 administered intravenously on stopping preterm labour compared to placebo in pregnant women with advanced gestational age
- Trial name
- NCT00209326
- Testing
- FE200440
- Where
- 17 sites in Belgium, Czechia and 4 more
- Volunteers
- 163 people
- Sponsor
- Ferring Pharmaceuticals
Growth, Development
Preterm Infant Growth
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
- Conditions
- Growth, Development, Infant
- Trial name
- NCT01162798
- Testing
- infant formula, control infant formula
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Infant
Effect of a Mixture of New Probiotic Strains in Preterm Infants
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0…
- Trial name
- PREBIOMA (NCT03701906)
- Testing
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Intra-amniotic Infection, Preterm Birth
Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)
- Trial name
- PPROM (NCT00701350)
- Where
- 4 sites in United States
- Volunteers
- 79 people
- Sponsor
- ProteoGenix, Inc.
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
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Preterm Labor, Preterm Birth
MIRACLE of LIFE Study
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1.
- Conditions
- Preterm Labor, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane
- Trial name
- MoL (NCT06074601)
- Testing
- Mirvie Predictive Test for Adverse Pregnancy Outcomes
- Where
- 10 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Mirvie
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Preterm Birth
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm…
- Trial name
- 170HP (NCT00163020)
- Testing
- 17-alpha-hydroxyprogesterone caproate injectable
- Where
- 18 sites in United States
- Volunteers
- 321 people
- Sponsor
- Obstetrix Medical Group
Post Partum Hemorrhage
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant…
- Trial name
- NCT06968481
- Testing
- Oxytocin sublingual, Oxytocin IM
- Where
- Nigeria
- Volunteers
- 330 people
- Sponsor
- Insud Pharma
Preterm Labor
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.
- Trial name
- TERM (NCT02326142)
- Testing
- OBE001
- Where
- 23 sites in Belgium, Germany and 4 more
- Volunteers
- 10 people
- Sponsor
- ObsEva SA
Obstetric Labour, Premature
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in…
- Trial name
- NCT01867996
- Testing
- Retosiban, EFZ 600 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Prematurity
Probiotics Supplementation in Premature Infants
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
- Trial name
- NCT01379417
- Testing
- Probiotic supplementation
- Where
- 3 sites in France
- Volunteers
- 199 people
- Sponsor
- Société des Produits Nestlé (SPN)
Preterm Birth
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
This is a research study to quantitatively assess the development of non-nutritive suck (NNS) and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare this with two clinical assessment tools…
- Trial name
- NCT01069731
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- KC BioMediX, Inc
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries