Premature Rupture of Membrane Clinical Trial
— RECHOBIOLOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Biosynex Company |
France,
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 |
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