Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)

NCT04237142 | Unknown

• 2 other identifiers: RBHP 2019 GALLOT2019-A02306-51
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period \<48 hours in case of pPROM.

Conditions

Premature Rupture of Membrane

Keywords

Preterm premature rupture of membranes; Biomarkers; Latency period; Predictive Value of Tests

Outcome Measures

Primary Outcomes (7)

• total IGFBP1 in vaginal secretion at admission

  Results of the tests detecting total IGFBP1 (positive/ negative)

  Day 0

• native IGFBP1 in vaginal secretion at admission

  Results of the tests detecting native IGFBP1 (positive/ negative)

  Day 0

• PP14 in vaginal secretion at admission

  PP14 values in vaginal secretion at admission dosed using the ELISA technique

  Day 0

• PIBF in vaginal secretion at admission

  PIBF values in vaginal secretion at admission dosed using the ELISA technique

  Day 0

• PIBF in maternal serum at admission

  PIBF values in maternal serum at admission dosed using the ELISA technique

  Day 0

• MIF in maternal serum at admission

  MIF values in maternal serum at admission dosed using the ELISA technique

  Day 0

• Ultrasound length of cervix measured at the admission

  Length of cervix was maesured by ultrasound at the admission (millmeters)

  Day 0

Study Arms (1)

Eligible patients who had consented to participate

EXPERIMENTAL

Eligible patients who had consented to participate to the study, namely parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week with cervical dilation \< 4cm and without known uterine malformation, fetal malformation, placenta previa or abundant metrorrhagia. Patients underwent vaginal swabbing and blood sample collection at the admission.

Diagnostic Test: Vaginal secretions collection; Diagnostic Test: Blood sample

Interventions

Vaginal secretions collection DIAGNOSTIC_TEST

Vaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and sent to the laboratory for subsequent analysis of biomarkers (IGFBP1 T/N, PIBF, PP14) and storage.

Eligible patients who had consented to participate

Blood sample DIAGNOSTIC_TEST

2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF)

Eligible patients who had consented to participate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week.
• Capacity to give informed consent.
• Coverage by a French social security scheme.

You may not qualify if:

• Refusal to participate
• pPROM formally occurred more than 24 hours ago (free flow or positive breakage test)
• Cervical dilatation ≥ 4 cm
• Multiple Pregnancy
• Known uterine malformation
• Fetal Malformation
• Placenta previa
• Abundant metrorrhagia
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Biosynex Company: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Preterm Premature Rupture of the Membranes

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Denis Gallot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Results of the biological tests are masked for the clinician and the patient and therefore do not modify the current management. Results will be given after delivery in order to not influence the current medical care of the patient.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: March 10, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

FR (1)