Clinical trials: Labour
Term Labour
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
- Trial name
- NCT03409146
- Testing
- Monica Novii Wireless Patch System
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
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
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
Obstetric Labour, Premature
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide…
- Trial name
- ARIOS (NCT02292784)
- Testing
- Retosiban, Atosiban
- Where
- 26 sites in United States, Belgium and 9 more
- Volunteers
- 98 people
- Sponsor
- GlaxoSmithKline
Labour Onset
Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor
The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife…
- Trial name
- NCT03982654
- Testing
- Bloomlife
- Where
- 2 sites in Belgium
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
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
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
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
Labour Onset and Length Abnormalities, Labor; Forced or Induced, Affecting Fetus or Newborn
Dilapan-S/Dilasoft E-Registry in Induction of Labor
International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
- Trial name
- DSREGISTRYIL (NCT02318173)
- Testing
- Dilapan-S
- Where
- 11 sites in United States, Czechia and 5 more
- Volunteers
- 444 people
- Sponsor
- Medicem International CR s.r.o.
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
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
Induction of Labour
REgistry of MisOprostol 200 µg Vaginal dElivery System
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included.
- Trial name
- REMOVE (NCT02242214)
- Testing
- Misoprostol
- Where
- Netherlands
- Volunteers
- 106 people
- Sponsor
- Ferring Pharmaceuticals
Obstetric Labour, Premature, Premature Ejaculation
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
PreTerm 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
- NCT00449709
- Testing
- GSK221149
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature, Premature Labor
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.
- Trial name
- NCT00457925
- Testing
- GSK221149A
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Labour Pain
Testing the Efficiency of a Device Meant to Relieve Labour Pain
The suggested research is aimed to test the effectiveness of an external mechanical device to be applied and used by the parturient herself in pain relieving during labour .
- Trial name
- NCT00426725
- Testing
- EasyLabour
- Where
- Israel
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- ACU Medical Technologies Ltd