Preterm Birth Clinical Trial
Official title:
A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
One of the most significant risk factors for preterm birth is previous pregnancy history. Women who have had a prior preterm birth have a 2.5-fold greater risk than women with no prior history of preterm birth. Prophylactic methods for prevention of preterm birth, including tocolytic drugs, bed rest, and other interventions such as cerclage, have been shown in most studies to be ineffective. One of the preventive measures that has shown effectiveness in randomized trials is the use of progesterone agents.9,10 Progesterone has been shown to support gestation and to inhibit uterine activity. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
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 | |
| Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
| Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
| Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
| Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
| Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
| Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
| Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
| Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
| Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
| Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
| Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
| Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
| Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
| Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
| Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
| Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|