Premature Rupture of Membrane Clinical Trial
Official title:
Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.
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.
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.
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