Clinical trials: Puerperal Disorders
Hypertensive Disorder of Pregnancy
Remote BP Monitoring in the PP Period
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the…
- Trial name
- NCT03728790
- Testing
- Remote Patient Monitoring
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Columbia University
Pain, Postoperative, Depression, Postpartum
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design.
- Trial name
- NCT05907213
- Testing
- Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2, Ketamine (Ketalar) Dose Level 3
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Postpartum Depression
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression.
- Trial name
- BRX-PPD (NCT05543746)
- Testing
- Brexanolone
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Hypertension
Monitoring and Testing of Blood Pressure in Postpartum Women
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies).
- Trial name
- SMART-BP (NCT05236725)
- Testing
- Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™, Instructions
- Where
- United States
- Volunteers
- 1,607 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Depression, Postpartum Depression
Personalized Integrated Chronotherapy for Perinatal Depression
Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes.
- Conditions
- Depression, Postpartum Depression, Prenatal Disorder, Circadian Dysregulation
- Trial name
- NCT04364646
- Testing
- Personalized Integrated Chronotherapy
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Rhode Island Hospital
Other Chronic Postoperative Pain
High Pain Intervention in Cesarean Sections
In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later.
- Trial name
- NCT01298778
- Testing
- Duramorph 150, Acetaminophen, Duramorph 300
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Wake Forest University Health Sciences
Hypertension in Pregnancy, Hypertension in Postpartum
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Antihypertensive therapy has been used in pregnant patients antepartum to improve blood pressure (BP) elevation in cases of chronic hypertension, and postpartum for persistent hypertension after delivery in cases of gestational…
- Trial name
- NCT03595982
- Testing
- Procardia XL 30Mg, Procardia XL 60Mg
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hypertension in Pregnancy
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications.
- Trial name
- NCT04790279
- Testing
- Amlodipine, NIFEdipine ER
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Prisma Health-Upstate
Postpartum Hemorrhage
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood…
- Trial name
- NCT02083107
- Testing
- Misoprostol
- Where
- Egypt
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Depression, Tobacco Use Disorder
A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
This study evaluates a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth.
- Trial name
- NCT05044546
- Testing
- Behavioral Activation Therapy, Discussion, Health Education
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Multiple Sclerosis
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.
- Trial name
- NAPPREMS (NCT03046251)
- Testing
- Natalizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- State University of New York at Buffalo
Tobacco Use Cessation, Tobacco Use Disorder
Progesterone & Postpartum Relapse to Smoking
The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers.
- Trial name
- NCT01798394
- Testing
- Progesterone
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Breast Discharge Infected, Intraductal Papilloma of Breast
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
In this prospective clinical trial, patients who sign an approved informed consent for ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the study.
- Trial name
- NCT01901562
- Testing
- Ductoscopic papillectomy
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Montefiore Medical Center
Pain Management, Vaginal Delivery
Post-partum Non-pharmacologic Pain Management
This study aims to examine whether use of an abdominal binder for postpartum patients after vaginal delivery can effectively manage their pain and reduce the need for pharmacologic analgesics.
- Trial name
- NCT03903172
- Testing
- Abdominal binder
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Wright State University
Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium
Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug…
- Conditions
- Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester, Drug Use
- Trial name
- NCT03826342
- Testing
- Health Check-up for Expectant Moms, Time, attention, and information-matched control
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- University of Michigan
Pregnancy Weight Gain, Postpartum Weight Retention
Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile…
- Conditions
- Pregnancy Weight Gain, Postpartum Weight Retention, Childhood Obesity, Gestational Diabetes
- Trial name
- H42/H4U (NCT04724330)
- Testing
- Healthy for Two/Healthy for You
- Where
- United States
- Volunteers
- 534 people
- Sponsor
- Johns Hopkins University
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
Opioid-Related Disorders, NAS
MOms in REcovery (MORE) Study: Defining Optimal Care
Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with…
- Conditions
- Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
- Trial name
- MORE (NCT04251208)
- Testing
- Observational Study
- Where
- 10 sites in United States
- Volunteers
- 2,510 people
- Sponsor
- Trustees of Dartmouth College
Depression, Postpartum
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
- Trial name
- NCT01842542
- Testing
- NeuroStar Transcranial Magnetic Stimulation (TMS)
- Where
- 8 sites in United States
- Volunteers
- 25 people
- Sponsor
- Neuronetics