Clinical trials: Intrauterine Fetal Demise
Stillbirth, Placental Insufficiency
Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
- Trial name
- PRACTICE (NCT07144839)
- Testing
- Data Collection Throughout Pregnancy and Delivery
- Where
- United States
- Volunteers
- 640 people
- Sponsor
- Oregon Health and Science University
Preterm Birth, Small for Gestational Age (SGA)
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants.
- Conditions
- Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy
- Trial name
- ABLE (NCT06723392)
- Testing
- Oral nitrofurantoin monohydrate/macrocrystals
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Assessment of Fetal Movement, Pregnancy
Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
The surveillance of pregnancies at risk for fetal loss secondary to high-risk maternal or fetal conditions remains a mainstay of perinatal care.
- Conditions
- Assessment of Fetal Movement, Pregnancy, Pregnancy Complications, Pregnancy Complications Affecting Fetus (Diagnosis)
- Trial name
- WWA (NCT07626112)
- Testing
- Smartphone Application
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kenneth Moise MD
Intrauterine Fetal Demise, Fetal Death
Mifepristone Induction for Fetal Demise
Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater.
- Trial name
- MIFD (NCT02620904)
- Testing
- Mifepristone
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Chronic Histiocytic Intervillositis, Intrauterine Growth Retardation
Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis
Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of 5 in 10,000 pregnancies. This rare condition is associated with placental inflammatory lesions leading to severe and recurrent obstetrical…
- Conditions
- Chronic Histiocytic Intervillositis, Intrauterine Growth Retardation, Fetal Death in Utero, Miscarriage
- Trial name
- RH-PL (NCT05936333)
- Testing
- Biological collection
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Malaria,Falciparum, Malaria in Pregnancy
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL)…
- Conditions
- Malaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, Pregnancy
- Trial name
- INTREPiD (NCT05757167)
- Testing
- Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
- Where
- 2 sites in Democratic Republic of the Congo, Kenya
- Volunteers
- 2,174 people
- Sponsor
- Duke University
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
Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome
TTP and aHUS in Complicated Pregnancies
A single site observational study aiming to: (i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii)…
- Conditions
- Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia, HELLP Syndrome
- Trial name
- NCT03605511
- Testing
- ADAMTS 13, complement and angiogenic biomarkers
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- University College, London
Pre-eclampsia, Obesity
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
Obesity is a growing problem in East London and every other woman who enters pregnancy is obese or overweight. In addition to obesity, other metabolic risk factors such as raised lipids, high blood pressure and diabetes increase…
- Conditions
- Pre-eclampsia, Obesity, Raised Lipids, High Blood Pressure
- Trial name
- ESTEEM (NCT02218931)
- Testing
- Targeted ESTEEM diet, Non-randomised cohort
- Where
- United Kingdom
- Volunteers
- 3,442 people
- Sponsor
- Queen Mary University of London
IUD, Analgesia
TENS Unit for Analgesia During IUD Insertion
Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained.
- Conditions
- IUD, Analgesia, Patient Preference, Pain, Acute
- Trial name
- NCT06240260
- Testing
- TENS (transcutaneous electrical nerve stimulation) unit, Standard care
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tufts Medical Center
Stillbirth, Neonatal Death
Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.
- Trial name
- NCT03290924
- Testing
- Low dose high frequency health worker training approach, Active Comparison
- Volunteers
- 40 people
- Sponsor
- Jhpiego
Pregnancy, Stillbirth
Zambian Preterm Birth Prevention Study
This prospective non-intervention cohort study will enroll women in the first or early second trimester of pregnancy and follow them through delivery (or end of pregnancy) and 1 year postpartum.
- Conditions
- Pregnancy, Stillbirth, Preterm Birth
- Trial name
- ZAPPS (NCT02738892)
- Where
- 2 sites in Zambia
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Fetal Distress, Perinatal Asphyxia
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of…
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Trial name
- PRISM (NCT05946681)
- Where
- Zambia
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Maternal Death, Maternal Morbidity
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in…
- Conditions
- Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death
- Trial name
- BetterBirth (NCT02148952)
- Testing
- WHO Safe Childbirth Checklist Program
- Where
- India
- Volunteers
- 157,689 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Stillborn Caesarean Section
Subarachnoid Administration of Levobupivacaine for Cesarean Section
The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in…
- Trial name
- NCT01582607
- Testing
- Bupivacaine plain, Ropivacaine plain, Levobupivacaine plain
- Where
- Greece
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University of Patras
Fetal Growth Retardation, Stillbirth and Fetal Death
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments…
- Conditions
- Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
- Trial name
- PROTECTMe (NCT05651347)
- Testing
- Melatonin 10 MG
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Monash University
Stillborn Caesarean Section
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent…
- Trial name
- NCT01558713
- Testing
- Bupivacaine- Fentanyl - Normal Saline, Ropivacaine-Fentanyl-Normal Saline, Levobupivacaine- Fentanyl- Normal Saline
- Where
- Greece
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Patras
Pregnancy Complications, Delivery;Abnormal;Stillbirth
Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions.
- Trial name
- OUTSET-1 (NCT03439956)
- Testing
- Transvaginal specimen extraction
- Volunteers
- 200 people
- Sponsor
- Università degli Studi dell'Insubria
Fetal Distress, Stillbirth
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to…
- Conditions
- Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
- Trial name
- NCT02862925
- Testing
- Fetal Scalp Stimulation
- Where
- Tanzania
- Volunteers
- 550 people
- Sponsor
- Duke University