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Clinical Trials/NCT03108404
NCT03108404
Unknown
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country120 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perinatal Mortality
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
120
Locations
1
Primary Endpoint
The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
January 6, 2020
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.

Time Frame: 1 day

Study Sites (1)

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