Clinical trial NCT04237142: Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)
Official title: Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Rupture of Membrane
Keywords: Preterm premature rupture of membranes
Biomarkers
Latency period
Predictive Value of Tests
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Biosynex Company
First posted: 2020-01-23
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: total IGFBP1 in vaginal secretion at admission
timeFrame: Day 0
measure: native IGFBP1 in vaginal secretion at admission
timeFrame: Day 0
measure: PP14 in vaginal secretion at admission
timeFrame: Day 0
measure: PIBF in vaginal secretion at admission
timeFrame: Day 0
measure: PIBF in maternal serum at admission
timeFrame: Day 0
measure: MIF in maternal serum at admission
timeFrame: Day 0
measure: Ultrasound length of cervix measured at the admission
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Denis Gallot
role: PRINCIPAL_INVESTIGATOR
References: