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

Not Applicable

• Conditions: Premature Rupture of Membrane
• Interventions: Diagnostic Test: Vaginal secretions collection; Diagnostic Test: Blood sample

• Registration Number: NCT04237142
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Status Verified: 2020-03
• Study Start: 2020-03-10
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eligible patients who had consented to participate	Blood sample	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.
Eligible patients who had consented to participate	Vaginal secretions collection	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France