Premature Rupture of Membrane
Conditions
Keywords
Preterm premature rupture of membranes, Biomarkers, Latency period, Predictive Value of Tests
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.
Interventions
DIAGNOSTIC_TESTVaginal 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.
DIAGNOSTIC_TESTBlood sample
2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF)
Sponsors
Biosynex Company
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PP14 in vaginal secretion at admission | Day 0 | PP14 values in vaginal secretion 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) |
| native IGFBP1 in vaginal secretion at admission | Day 0 | Results of the tests detecting native IGFBP1 (positive/ negative) |
| PIBF in vaginal secretion at admission | Day 0 | PIBF 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 |
| 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) |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed