deltatrials
Active Not Recruiting INTERVENTIONAL NCT03976063

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

Updated 16 times since 2019 Last updated: Apr 20, 2026 Started: Oct 7, 2019 Primary completion: Nov 1, 2026 Completion: Nov 1, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jul 2019 – ~Nov 2019 · 4 months · monthly snapshot~Nov 2019 – ~Apr 2020 · 5 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshot~Sep 2022 – ~Jun 2023 · 9 months · monthly snapshot~Jun 2023 – ~Oct 2023 · 4 months · monthly snapshot~Oct 2023 – ~Mar 2024 · 5 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Dec 2025 · 6 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Apr 2026 · 4 months · monthly snapshotApr 28, 2026 – present · 3 months · daily API

Change History

16 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting · Phase: PHASE3None

  2. Jan 2026 — Apr 2026 [monthly]

    Recruiting PHASE3

  3. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  4. Jun 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

  5. Sep 2024 — Jun 2025 [monthly]

    Recruiting PHASE3

Show 11 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  2. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  3. Oct 2023 — Mar 2024 [monthly]

    Recruiting PHASE3

  4. Jun 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  5. Sep 2022 — Jun 2023 [monthly]

    Recruiting PHASE3

  6. Sep 2021 — Sep 2022 [monthly]

    Recruiting PHASE3

  7. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  8. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  9. Apr 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  10. Nov 2019 — Apr 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  11. 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

Sponsor contact:
  • 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
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations