Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation (TOCOPROM)
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
Sponsor: Assistance Publique - Hôpitaux de Paris
A observational or N/A phase clinical study on Preterm Premature Rupture of Membrane, this trial is ongoing. The trial is conducted by Assistance Publique - Hôpitaux de Paris and has accumulated 16 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
16 versions recorded-
Apr 28, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE3 → None
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Jan 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
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Jun 2025 — Dec 2025 [monthly]
Recruiting PHASE3
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Sep 2024 — Jun 2025 [monthly]
Recruiting PHASE3
▶ Show 11 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Mar 2024 — Jul 2024 [monthly]
Recruiting PHASE3
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Oct 2023 — Mar 2024 [monthly]
Recruiting PHASE3
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Jun 2023 — Oct 2023 [monthly]
Recruiting PHASE3
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Sep 2022 — Jun 2023 [monthly]
Recruiting PHASE3
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Sep 2021 — Sep 2022 [monthly]
Recruiting PHASE3
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Apr 2021 — Sep 2021 [monthly]
Recruiting PHASE3
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Jan 2021 — Apr 2021 [monthly]
Recruiting PHASE3
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Apr 2020 — Jan 2021 [monthly]
Recruiting PHASE3
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Nov 2019 — Apr 2020 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jul 2019 — Nov 2019 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Assistance Publique - Hôpitaux de Paris
- Groupe de Recherche en Obstétrique et Gynécologie
- Institut National de la Santé Et de la Recherche Médicale, France
- Ministry of Health, France
- URC-CIC Paris Descartes Necker Cochin
For direct contact, visit the study record on ClinicalTrials.gov .