Clinical trials: Puerperal Disorder
Depression, Postpartum
Type II Diabetes Mellitus in Patients Exposed to Pravastatin and Paroxetine
Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability to regulate glucose levels in the blood. Diabetes can cause many severe complications if not treated properly.
- Trial name
- NCT01602913
- Testing
- Pravastatin alone, Paroxetine alone, Pravastatin and paroxetine combined
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Postpartum Depression
A Six-Month Prospective Follow-Up Study of WB001
This study is a 6-month follow-up study to WB001-001 conducted to assess and evaluate the durability of the effect of {WB001+TAU} beyond the 8-week treatment period.
- Trial name
- NCT05693792
- Testing
- Observational
- Sponsor
- Woebot Health
Mastitis, Breast Milk
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health
- Trial name
- NCT04032899
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- 3 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Postpartum Depression
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum…
- Trial name
- NCT02942004
- Testing
- SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
- Where
- 32 sites in United States
- Volunteers
- 138 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Postpartum Depression
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the…
- Trial name
- NCT02978326
- Testing
- SAGE-217 15/20 mg Oral Solution, SAGE 217 30 mg Capsules
- Where
- 27 sites in United States
- Volunteers
- 276 people
- Sponsor
- Biogen
Postpartum Hemorrhage
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
- Trial name
- PEARLE (NCT02883673)
- Testing
- Jada System
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Alydia Health
Depression, Depressive Disorder
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
- Conditions
- Depression, Depressive Disorder, Depression, Postpartum, Behavioral Symptoms
- Trial name
- NCT03228394
- Testing
- Ganaxolone
- Where
- 16 sites in United States
- Volunteers
- 91 people
- Sponsor
- Marinus Pharmaceuticals
Insomnia
Evaluation of Digital Sleep Program to Improve Sleep Among New Parents
Sleep disturbances are highly prevalent during the postpartum period, with an estimated 40-60% of new parents experiencing inadequate sleep.
- Trial name
- NCT07302893
- Testing
- Digital CBT-I
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Udisense DBA Nanit
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
Attachment
Effects of Mother-infant Skin-to-skin Contact in Postpartum Women
When a newborn is delivered in good physiological condition, immediate skin-to-skin contact with the mother is required. Skin-to-skin contact has a wide range of benefits for both mother and baby.
- Trial name
- NCT06781307
- Testing
- skin to skin
- Where
- Taiwan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Jen-Ai Hospital Institutional Review Board
Mastitis
Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
- Trial name
- NCT02203877
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- Spain
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Depression, Postpartum
IMI PROTECT(WP2): Antidepressants & Fractures
The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 and Workgroup 1.
- Trial name
- NCT01587729
- Testing
- Tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) antidepressants
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Postpartum Depression
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
- Trial name
- NCT02285504
- Testing
- SAGE-547
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Post Partum Haemorrhage
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.
- Trial name
- NCT02908126
- Testing
- Oxytocin
- Where
- Sweden
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Oxytone Bioscience BV
Postpartum Hemorrhage
Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings.
- Trial name
- NCT02999100
- Testing
- IH Oxytocin, IM Oxytocin, IV Oxytocin
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Postpartum Hemorrhage
Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers
Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum haemorrhage (PPH). However, in resource-poor settings within the developing world, the stability and therefore effectiveness of prophylactic IM…
- Trial name
- NCT02542813
- Testing
- IM oxytocin 10 IU, IH oxytocin 50 mcg, IH oxytocin 200 mcg
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Severe Postpartum Haemorrhage
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not…
- Trial name
- NCT04444856
- Testing
- Eptacog alfa (activated), Standard of care
- Where
- Switzerland
- Volunteers
- 225 people
- Sponsor
- Novo Nordisk A/S
Postpartum Depression
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
- Trial name
- NCT05551195
- Testing
- WB001, ED001
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Woebot Health
Post Partum Depression
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).
- Trial name
- NCT03665038
- Testing
- Brexanolone
- Where
- 17 sites in United States
- Volunteers
- 28 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Post-partum Depression
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.
- Trial name
- NCT05077644
- Testing
- Stella (TM) Mobile Application
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Curio Digital Therapeutics, Inc.