Clinical trials: Preterm Pregnancy
GDM, Preterm Preeclampsia
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of…
- Conditions
- GDM, Preterm Preeclampsia, Preeclampsia, Fetal Growth Restriction (FGR)
- Trial name
- ASPIRE (NCT07669935)
- Testing
- None (this is an observational study with no intervention)
- Where
- 2 sites in United States
- Volunteers
- 5,500 people, healthy volunteers welcome
- Sponsor
- Medicines360
Preterm Birth Complication, Preterm Birth
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
The goal of this clinical trial is to learn if a personalized prenatal support program [(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)] works to…
- Conditions
- Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia
- Trial name
- PTBCARE+ (NCT06915428)
- Testing
- Care coordination, Electronic massage, support gift #1
- Where
- United States
- Volunteers
- 1,228 people
- Sponsor
- University of North Carolina, Chapel Hill
Premature Birth, Pregnancy Preterm
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California.
- Conditions
- Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety
- Trial name
- EMBRACE (NCT04154423)
- Testing
- Glow! Group Prenatal Care, Individual Prenatal Care with CPSP
- Where
- 2 sites in United States
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Environmental Exposure, Pregnancy Related
Prenatal Education on Environmental Exposures During Pregnancy Study (PEEPS)
The purpose of this project is to reduce maternal environmental exposures to toxicants through a patient education program designed to help pregnant women learn about exposure through consumption of contaminated seafood and to be…
- Conditions
- Environmental Exposure, Pregnancy Related, Preterm Birth, Chronic Respiratory Disease
- Trial name
- PEEPS (NCT07758114)
- Testing
- Educational Intervention
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM)
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
Pregnancy is a physiological process; however, it is also a dynamic period during which obstetric and medical complications that may threaten maternal and fetal health can occur.
- Conditions
- Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM), High-Risk Pregnancy
- Trial name
- NCT07559071
- Testing
- Emotional Freedom Technique (EFT), Music Therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 177 people
- Sponsor
- Selcuk University
Preterm Birth, Preterm Labor
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth).
- Conditions
- Preterm Birth, Preterm Labor, Multiple; Pregnancy, Complicated, Twin Dichorionic Diamniotic Placenta
- Trial name
- SPRUCE (NCT06053697)
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Liverpool
Pregnant Women, Pregnancies at Increased Risk of Preterm Birth
Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth
This randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies.
- Trial name
- NCT06975943
- Testing
- Progesterone 200 mg vaginal capsules
- Where
- Indonesia
- Volunteers
- 48 people
- Sponsor
- Dr. Soetomo General Hospital
Short Cervix, PROM, Preterm (Pregnancy)
Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes
This study aims at assessing the efficacy, reliability, and clinical impact of Amniotic Fluid analysis by Nanopore DNA sequencing compared to the standard bacterial cultures in detecting intra-amniotic/inflammation in patients…
- Trial name
- CIPRO (NCT07792083)
- Testing
- amniotic fluid collection
- Where
- Italy
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
PROM, Preterm (Pregnancy)
Novel Use of Central Venous Pressure (CVP) Set With McDonald Cerclage Technique for Amnioinfusion in Preterm Premature Rupture of Membranes Improves Amniotic Fluid Index and Neonatal Outcomes
This prospective, two-arm, non-randomized comparative interventional study evaluated the effectiveness of amnioinfusion using a central venous pressure (CVP) set compared with conventional transabdominal amnioinfusion in pregnant…
- Trial name
- CAM-PPROM (NCT07774832)
- Testing
- CVP-Set Amnioinfusion With McDonald Cerclage, Conventional transabdominal amnioinfusion
- Where
- Indonesia
- Volunteers
- 40 people
- Sponsor
- Herlambang Herlambang
Small for Gestational Age at Delivery, Gestational Weight Gain
BEP Targeting Strategies in Ethiopia
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia.
- Conditions
- Small for Gestational Age at Delivery, Gestational Weight Gain, Stillbirth, Preterm Birth
- Trial name
- BEP (NCT06125860)
- Testing
- Targeted BEP based on baseline nutritional status, Targeted BEP based on baseline nutritional status and monthly GWG monitoring, Universal BEP
- Where
- Ethiopia
- Volunteers
- 7,851 people
- Sponsor
- Harvard School of Public Health (HSPH)
Respiratory Distress Syndrome, Preterm Pregnancy
Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6…
- Conditions
- Respiratory Distress Syndrome, Preterm Pregnancy, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT06421506
- Testing
- Less invasive surfactant administration during high flow nasal cannula treatment
- Where
- United Kingdom
- Volunteers
- 245 people
- Sponsor
- King's College Hospital NHS Trust
Preterm Birth, Cervix; Pregnancy
Prospective Evaluation of Pathways for Preterm Birth
This is a single center, prospective cohort study of pregnant patients at high risk for spontaneous preterm birth: patient's with history of spontaneous preterm birth, patient's with a short cervix and patient's symptomatic for…
- Trial name
- PEPP (NCT05246579)
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- John O'Brien, MD
Periodontal Disease, Pregnancy
Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers
Periodontal disease is a chronic inflammatory condition that affects the tissues supporting the teeth and may contribute to systemic inflammation and oxidative stress.
- Conditions
- Periodontal Disease, Pregnancy, Preterm Birth
- Trial name
- NCT07699978
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Diabetes Mellitus, Type 2, Preterm Birth
Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Preterm Birth, Pregnancy, High Risk, Diabetes, Gestational
- Trial name
- NCT04542148
- Testing
- Sliding Scale Insulin, Up-Titration of Home Insulin, Continuous Insulin Infusion
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- University of Alabama at Birmingham
Preterm Birth, Pregnancy
Hippo-YAP Pathway and Related miRNAs in Preterm Birth
This completed observational study evaluated the expression of Hippo-YAP pathway-related genes and proteins and selected microRNAs in maternal blood, placental tissue, and myometrial tissue obtained from women who underwent…
- Conditions
- Preterm Birth, Pregnancy, Preterm Labor
- Trial name
- HIPPO-PTB (NCT07695467)
- Testing
- Laboratory Biomarker Analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people
- Sponsor
- Cumhuriyet University
Fetal Growth Retardation, Low Birth Weight
BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low…
- Conditions
- Fetal Growth Retardation, Low Birth Weight, Preterm Birth, Gestational Weight Gain
- Trial name
- Target-BEP (NCT05576207)
- Testing
- Balanced energy and protein supplement for pregnant women, Multiple Micronutrient Supplement for pregnant women
- Where
- Bangladesh
- Volunteers
- 3,390 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Antenatal Health, Antenatal Care
Healthy Expectancy Through Routine Antenatal STI Screening
This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and…
- Conditions
- Antenatal Health, Antenatal Care, STI, Chlamydia Trachomatis Infection in Pregnancy
- Trial name
- HERA (NCT07458802)
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening
- Where
- Botswana
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Adriane Wynn
Pregnancy Preterm, Pregnancy Prom
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane…
- Conditions
- Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy)
- Trial name
- NCT05345457
- Testing
- Azithromycin Pill, Amoxicillin Pill
- Where
- 3 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Pregnancy Preterm, Premature Birth
The Periviable GOALS Decision Support Tool
The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a…
- Conditions
- Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature
- Trial name
- NCT05264779
- Testing
- Periviable GOALS DST
- Where
- 12 sites in United States
- Volunteers
- 300 people
- Sponsor
- Indiana University
Preterm Birth, Cervical Insufficiency
Bed Rest With a Short Cervix on Preterm Birth
Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.
- Conditions
- Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications
- Trial name
- BEWISE (NCT07577388)
- Testing
- Activity Restriction, No Activity Restriction
- Volunteers
- 6,000 people
- Sponsor
- Julie Glavind