Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Status Completed

Clinical Trial Summary

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes. Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Clinical Trial Description

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups. Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days. While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00579553
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	N/A
Start date	October 2006
Completion date	May 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Active, not recruiting	`NCT03655639` - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT03337659` - A Cluster Randomized Controlled Trial of FICare at 18 Months	N/A
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Completed	`NCT03251729` - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix	Phase 4
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Not yet recruiting	`NCT02880696` - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates	N/A
Completed	`NCT02913495` - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth	Phase 4
Completed	`NCT02879799` - Family Integrated Care (FICare) in Level II NICUs	N/A
Completed	`NCT02743572` - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants	N/A
Completed	`NCT02661360` - Effects of Swaddling on Infants During Feeding	N/A
Completed	`NCT01352234` - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia	Phase 4
Completed	`NCT01163188` - Social Adjustment and Quality of Life After Very Preterm Birth	N/A
Terminated	`NCT00675753` - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families	N/A
Terminated	`NCT00179972` - Evaluation of Pulse Oximetry Sensors in Neonates	N/A