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

Perinatal Mortality Clinical Trial

— PPROM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108404
• Other study ID #: RNI2016-13 Pr Tourneux-3
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: May 11, 2017
• Start date: January 1, 2017
• Est. completion date: January 6, 2020

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pierre TOURNEUX, PhD
• Phone: +33322668652
• Email: tourneux.pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Perinatal Death
• Perinatal Mortality
• Premature Birth
• Premature Rupture of Fetal Membranes
• Rupture

Intervention

Other:
• Validation of a diagnostic test
Validation of a diagnostic test

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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