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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2031-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Premature Rupture of Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nifedipine

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo of Nifedipine

Intervention Type DRUG

Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43

Interventions

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Nifedipine

Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)

Intervention Type DRUG

Placebo of Nifedipine

Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
* Singleton gestation
* Fetus alive at the time of randomization (reassuring fetal heart monitoring)
* 18 years of age or older
* French speaking
* Affiliated to social security regime or an equivalent system
* Informed consent and signed

Exclusion Criteria

* PPROM ≥ 24 hours before diagnosis
* Ongoing tocolytic treatment at the time of PPROM
* Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
* Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
* Cervical dilation \> 5 cm
* Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
* Major fetal anomaly
* Maternal allergy or contra-indication to Nifedipine or placebo drug components\*:

* Myocardial infarction
* Unstable angina pectoris
* Hepatic insufficiency
* Cardiovascular shock
* Beta blockers

placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose

* Coadministration of diltiazem or rifampicin
* Hypotension (systolic pressure \< 90 mmHg)
* Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Kayem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital

Elsa Lorthe, RM, PhD

Role: STUDY_DIRECTOR

INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University