Clinical trials: Preterm Labor
Preterm Birth
Trial of the Use of Antenatal Corticosteroids in Developing Countries
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.
- Trial name
- ACT (NCT01084096)
- Testing
- Increasing use of Antenatal Corticosteroids (ACS)
- Where
- 7 sites in Argentina, Guatemala and 4 more
- Volunteers
- 103,117 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Postpartum Depression, Small for Gestational Age at Delivery
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder…
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety
- Trial name
- HMHB (NCT03880032)
- Testing
- Cognitive Behavioral Therapy Intervention for Anxiety
- Where
- Pakistan
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Preterm Labor, Tobacco Use Disorder
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications.
- Trial name
- INFANTS (NCT04417595)
- Testing
- Fish Oil (Containing Omega-3 Acids), Olive Oil
- Where
- United States
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Preterm Birth
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy.
- Trial name
- NCT04933812
- Testing
- Facebook discussions and Virtual group meetings
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Duke University
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Preterm Delivery, Cervical Length
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the…
- Trial name
- SCAN (NCT00439374)
- Testing
- 17 alpha-hydroxyprogesterone caproate
- Where
- 14 sites in United States
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Premature Birth
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi.
- Trial name
- NCT03673709
- Testing
- Antenatal Care
- Where
- 7 sites in Malawi
- Volunteers
- 1,887 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Premature Birth, Decision Making
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners.
- Conditions
- Premature Birth, Decision Making, Prenatal Care, Resuscitation
- Trial name
- NCT04093492
- Testing
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention, ACOG links
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Pregnancy, Respiratory Distress Syndrome
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in…
- Conditions
- Pregnancy, Respiratory Distress Syndrome, Pregnancy Outcomes, Preterm Birth
- Trial name
- ALPS (NCT01222247)
- Testing
- Betamethasone
- Where
- 17 sites in United States
- Volunteers
- 2,831 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Preterm Birth, Injuries
Nurse-Family Partnership Impact Evaluation in South Carolina
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial.
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Trial name
- NFP (NCT03360539)
- Testing
- Nurse-Family Partnership
- Where
- 9 sites in United States
- Volunteers
- 5,670 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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
Premature Birth, Maternal Distress - Delivered
Heart Rate Variability and Prematurity
Mothers who deliver prematurely (<37 weeks of gestational age) experience intense stress and anxiety given that their child's survival and development might be compromised.
- Conditions
- Premature Birth, Maternal Distress - Delivered, Stress, Anxiety
- Trial name
- NCT03565874
- Testing
- Heart rate variability biofeedback
- Where
- Switzerland
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Lausanne Hospitals
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
Preterm Birth, Periodontal Disease
Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi
The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and…
- Conditions
- Preterm Birth, Periodontal Disease, Caries, Dental
- Trial name
- PPaX (NCT02333227)
- Testing
- Xylitol gum
- Where
- United States
- Volunteers
- 10,069 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Length of Pregnancy Prolongation in Hours
Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam
Preterm birth remains a major health concern affecting up to 12% of all live births prior to 37 weeks gestation. As preterm birth can often be associated with infection our proposal is to evaluate in a randomized fashion…
- Trial name
- NCT00589329
- Testing
- erythromycin and metronidazole (antibiotics)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Premature Rupture of Membranes
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
- Trial name
- FOLCROM (NCT01973036)
- Testing
- Foley Catheter, Oxytocin
- Where
- 5 sites in United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital