Clinical trials: In the Perinatal Period
Perinatal Depression, Postpartum Depression
Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study
During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for…
- Conditions
- Perinatal Depression, Postpartum Depression, Depression
- Trial name
- NCT03427528
- Testing
- Fathers and Babies (FAB), MB 1-on-1 plus TXT
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Human Immunodeficiency Virus, Perinatal Depression
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce…
- Trial name
- Periscope (NCT04143009)
- Testing
- Enhanced Friendship Bench, Enhanced Standard Care (Control), Adapted Friendship Bench
- Where
- 3 sites in Malawi
- Volunteers
- 92 people
- Sponsor
- University of North Carolina, Chapel Hill
Pain
The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such…
- Trial name
- NCT01601860
- Testing
- Use of non-pharmacological, Other: Routine care
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Depression, Postpartum
Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings.
- Trial name
- ROSE (NCT03267563)
- Testing
- EIAU, LICF, HICF
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Michigan State University
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Stillbirth, Neonatal Death
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital…
- Trial name
- NCT02273037
- Testing
- Fetal heart rate Doppler, Partograph
- Where
- 2 sites in Canada, Uganda
- Volunteers
- 1,987 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Perinatal Depression, Post Partum Depression
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period.
- Conditions
- Perinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
- Trial name
- NCT04051320
- Testing
- Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet, Micronized progesterone
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Mental Health Issue, Hiv
Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya
The investigators will recruit 40 pregnant women living with HIV divided into 2 groups (n=20 intervention group, n=20 control group).
- Conditions
- Mental Health Issue, Hiv, Breastfeeding, Exclusive
- Trial name
- NCT05219552
- Testing
- personalized lactation support
- Where
- 2 sites in Kenya
- Volunteers
- 40 people
- Sponsor
- University of California, San Francisco
Gestational Hypertension
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies.
- Trial name
- NCT01192412
- Testing
- Intervention is blood pressure management approach, Intervention is blood pressure management approach.
- Where
- 111 sites in United States, Argentina and 13 more
- Volunteers
- 987 people
- Sponsor
- University of British Columbia
Perinatal Depression, Perinatal Anxiety
Cognitive Behavioral Couple Therapy for Perinatal Distress
The hypotheses of the study are There will be differences in perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being in couples at Pre- and Post-Test levels during the…
- Trial name
- NCT06001021
- Testing
- Psychopharmacological Intervention, Cognitive Behavioral Couple Therapy, Combination of Psychopharmacological Intervention and CBCT
- Where
- Pakistan
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sameera Shafiq
HIV Infections, Pregnancy Related
HIV Testing Strategies in the Perinatal Setting
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers…
- Trial name
- NCT00503308
- Testing
- Abbreviated HIV test counseling
- Where
- United States
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV, Pregnancy
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts…
- Trial name
- NCT04571684
- Testing
- HITSystem 2.1
- Where
- 12 sites in Kenya
- Volunteers
- 1,639 people
- Sponsor
- University of Kansas Medical Center
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
- Trial name
- NCT00992836
- Testing
- Influenza A (H1N1) 2009 monovalent vaccine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 155 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Genetic Diseases, Genetic Syndrome
Perinatal Precision Medicine
This study will seek to determine if rapid genomic sequencing improves outcomes for acutely ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective, randomized, blinded study to either rapid…
- Conditions
- Genetic Diseases, Genetic Syndrome, Mendelian Disorders
- Trial name
- NSIGHT2 (NCT03211039)
- Testing
- Genomic sequencing and molecular diagnostic results, if any.
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
HIV Infections
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP)…
- Trial name
- NCT00109590
- Testing
- Didanosine, enteric-coated, Lopinavir/ritonavir, Nevirapine
- Where
- 7 sites in Thailand
- Volunteers
- 175 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Perinatal Depression, PostPartum Depression
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or…
- Trial name
- NCT02979444
- Testing
- Mothers and Babies Groups
- Where
- United States
- Volunteers
- 874 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus.
- Trial name
- NCT00992017
- Testing
- Influenza A (H1N1) monovalent vaccine
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)