Clinical trials: Preterm Labour
Premature Labor
Performance of the Monica Novii Wireless Patch System in Pre-term Labor
To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System…
- Trial name
- NCT03057275
- Testing
- Abdominal fetal/maternal monitoring
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- GE Healthcare
Obstetric Labour, Premature
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
This study in healthy, adult Japanese women will characterize the PK, safety and tolerability of retosiban at the therapeutic doses planned to be evaluated in Phase 3.
- Trial name
- NCT02377414
- Testing
- Retosiban solution for Infusion
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00404768
- Testing
- GSK221149A
- Where
- 57 sites in United States, Argentina and 9 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Threatened Preterm Labor
FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm…
- Trial name
- FB-CT2 (NCT06968364)
- Testing
- Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation., Transvaginal ultrasound
- Where
- 14 sites in Spain
- Volunteers
- 457 people, healthy volunteers welcome
- Sponsor
- Ultrasound-Innovation Medtech, S.L.
Preterm Delivery
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks'…
- Trial name
- ACS (NCT00201643)
- Testing
- Betamethasone or Dexamethasone (2nd course of ACS)
- Where
- 22 sites in United States
- Volunteers
- 437 people
- Sponsor
- Obstetrix Medical Group
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
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
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
Intra-amniotic Infection
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic…
- Trial name
- IAI (NCT00700219)
- Where
- 21 sites in United States
- Volunteers
- 900 people
- Sponsor
- ProteoGenix, Inc.
Intra-Amniotic Infection of Foetus
Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected…
- Trial name
- NCT03497234
- Testing
- Perilynx Analyzer to measure AF and VF fluid
- Where
- 5 sites in United States
- Sponsor
- Hologic, Inc.
Pre Term Labor, Multiple Pregnancy
Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.
- Trial name
- NCT01360905
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Obstetric Labour, Premature
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects.
- Trial name
- NCT01702376
- Testing
- Retosiban 100 mg, Retosiban 800 mg, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban.
- Trial name
- NCT02292771
- Testing
- Retosiban, Atosiban
- Where
- 21 sites in Belgium, Germany and 7 more
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Preterm Labor, Preterm Birth
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
- Trial name
- PRIME (NCT04301518)
- Testing
- Multimodal intervention strategy
- Where
- 18 sites in United States
- Volunteers
- 6,500 people, healthy volunteers welcome
- Sponsor
- Sera Prognostics, Inc.
Genital Mycoplasma Infection, High Risk Pregnancy
Evaluation of a Serology Diagnostic Kit for the Detection of Genital Mycoplasma in Pregnancy
Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy outcome, especially preterm labor and delivery.
- Conditions
- Genital Mycoplasma Infection, High Risk Pregnancy, Preterm Labor
- Trial name
- NCT01281319
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Promyco Diagnostics
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
Preterm Labor, PreTerm Birth
Electrical Inhibition of Human Preterm Contractions
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration…
- Conditions
- Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
- Trial name
- NCT02983240
- Testing
- Electrical Uterine Pacemaker
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- e-Bio Corp
Pregnancy
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication).
- Trial name
- NCT00086177
- Testing
- 8% progesterone vaginal gel
- Where
- 45 sites in United States
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.
Obstetric Labour, Premature, Premature Ejaculation
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
- Trial name
- NCT00549211
- Testing
- GSK557296
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4…
- Trial name
- NCT01627587
- Testing
- GSK221149 750 mg, Ketoconazole, GSK221149 100 mg
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline