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

C

Centre Hospitalier Universitaire, Amiens

Status

Unknown

Conditions

Perinatal Mortality
Premature Rupture of Fetal Membranes

Treatments

Other: Validation of a diagnostic test

Study type

Observational

Funder types

Other

Identifiers

NCT03108404
RNI2016-13 Pr Tourneux-3

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Pierre TOURNEUX, PhD

Data sourced from clinicaltrials.gov

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