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Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation — TOCOPROM  

Preterm Premature Rupture of Membrane Clinical Trial

Official title:
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03976063
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Gilles Kayem, MD, PhD
Phone 00 33 1 44 73 51 18
Email gilles.kayem@aphp.fr
Status Recruiting
Phase Phase 3
Start date October 7, 2019
Completion date November 2030
View Details
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