Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation

NCT ID: NCT03108404

Last Updated: 2017-05-12

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-06

Brief Summary

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Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.

Detailed Description

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Conditions

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Perinatal Mortality Premature Rupture of Fetal Membranes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Validation of a diagnostic test

Validation of a diagnostic test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women with PPROM between 22 weeks and 27 weeks and 6 days are eligible for this study

Exclusion Criteria

* Therapeutic abortion / terminaison of pregnancy
* Intra uterine demise
* active labor with cervical dilatation of 3 cm with regular contractions.
* Triplet pregnancies
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre TOURNEUX, PhD

Role: CONTACT

+33322668652

Facility Contacts

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Pierre TOURNEUX, PhD

Role: primary

+33322668652

Other Identifiers

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RNI2016-13 Pr Tourneux-3

Identifier Type: -

Identifier Source: org_study_id

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