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

Premature Rupture of Membrane Clinical Trial

— RECHOBIOL  

Official title:

Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237142
• Other study ID #: RBHP 2019 GALLOT
• Secondary ID: 2019-A02306-51
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: March 2023

Study information

• Verified date: March 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Preterm premature rupture of membranes (pPROM) is defined as a spontaneous rupture before the start of labor ("premature" rupture) and before 37 weeks of gestation ("preterm"). pPROM concern 2-3% of pregnancies. It is the main cause of prematurity since it is responsible for 24 to 42% of preterm deliveries. The time between PROM and childbirth is named the latency period. Its total duration can vary from a few hours to several weeks. Childbirth occurs within 48 hours of rupture for 18 to 93% of cases, within 7 days for 56 to 96% and within 28 days for 78 to 100%. The earlier PROM occurs during pregnancy, the longer the latency period is. The factors associated with a shorter latency period are: cervical changes during admission for pPROM, a shortened cervix on ultrasound or a threat of premature delivery prior to PROM, the existence of uterine contractions, oligoamnios, and the occurrence of a materno-fetal complication of pPROM.

In a pPROM situation, a prolonged latency period improves the neonatal prognosis by increasing the gestational age of birth, gives the possibility of administering the corticosteroid treatment of fetal pulmonary maturation and also allows an in utero transfer in an adapted maternity.

Several studies have shown a correlation between the length of the cervix during rupture and the latency period in the context of pPROM.

To date, there are no effective biomarkers used in current practice to predict this latency period.

We want to assess the diagnostic performance of different vaginal (PIBF / PP14 / IGFBP1 native and total) and serum (PIBF / MIF) markers as well as the ultrasound length of the cervix to predict the duration of this latency period in order to better anticipate the risk of prematurity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membrane
• Rupture

Intervention

Diagnostic Test:
• Vaginal secretions collection
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.
• Blood sample
2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Biosynex Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total IGFBP1 in vaginal secretion at admission	Results of the tests detecting total IGFBP1 (positive/ negative)	Day 0
Primary	native IGFBP1 in vaginal secretion at admission	Results of the tests detecting native IGFBP1 (positive/ negative)	Day 0
Primary	PP14 in vaginal secretion at admission	PP14 values in vaginal secretion at admission dosed using the ELISA technique	Day 0
Primary	PIBF in vaginal secretion at admission	PIBF values in vaginal secretion at admission dosed using the ELISA technique	Day 0
Primary	PIBF in maternal serum at admission	PIBF values in maternal serum at admission dosed using the ELISA technique	Day 0
Primary	MIF in maternal serum at admission	MIF values in maternal serum at admission dosed using the ELISA technique	Day 0
Primary	Ultrasound length of cervix measured at the admission	Length of cervix was maesured by ultrasound at the admission (millmeters)	Day 0