Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163020
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2005-09-09
Brief Title:
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth PTB in Twin and Triplet Pregnancies
Sponsor:
Obstetrix Medical Group
Organization:
Pediatrix
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
170HP
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OBX 0012 | OTHER | Obstetrix CREQ Protocol Number | None |