Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03976063
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2019-05-29
Brief Title:
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation a Double-blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TOCOPROM
Brief Summary:
The purpose of this study is to assess whether short-term 48 hr tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks gestation
Detailed Description:
Preterm premature rupture of membranes PPROM complicates 3 of pregnancies and accounts for one-third of preterm births It is a leading cause of neonatal mortality and morbidity and increases the risk of maternal infectious morbidity In cases of early PPROM 22 to 33 completed weeks gestation expectant management is recommended in the absence of labor chorioamnionitis or fetal distress Antenatal steroids and antibiotics administration are recommended by international guidelines However there is no recommendation regarding tocolysis administration in the setting of PPROM In theory reducing uterine contractility should delay delivery and reduce risks of prematurity and neonatal adverse consequences Likewise a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality However tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection potentially associated with neonatal death or long-term sequelae including cerebral palsy
The purpose of this study is to assess whether short-term 48 hr tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks gestation
The purpose of this study is to assess whether short-term 48 hr tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks gestation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None