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

• Conditions: Perinatal Mortality; Premature Rupture of Fetal Membranes

• Registration Number: NCT03108404
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France