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

NCT03108404 | Unknown

• 1 other identifier: RNI2016-13 Pr Tourneux-3
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Mortality; Premature Rupture of Fetal Membranes

Keywords

predictive score

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Interventions

Validation of a diagnostic test OTHER

Validation of a diagnostic test

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with premature rupture of membranes between 22 + 0 and 27 + 6 SA included

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Perinatal Death; Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications

Central Study Contacts

Pierre TOURNEUX, PhD

CONTACT

+33322668652; tourneux.pierre@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 11, 2017
• Study Start: January 1, 2017
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

FR (1)