Clinical Trials Logo
  1. Home
  2. Preterm Birth
  3. NCT00163020

17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies — 170HP  

Preterm Birth Clinical Trial

Official title:
17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial

Clinical Trial Summary

Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.

This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are:

1. Twin pregnancy

2. Triplet pregnancy

Clinical Trial Description

Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity.

In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates.

The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00163020
Study type Interventional
Source Mednax Center for Research, Education and Quality
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2004
Completion date August 2009
View Details
See also
  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 NCT04811742 - Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn N/A