Status:
UNKNOWN
Premature Rupture Membranes and tPTL: a Personalised Approach (PROMPT)
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Conditions:
Preterm Rupture of Membranes
Threatened Preterm Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Preterm birth (less than 37 weeks) affect approximately 8% of babies in the UK and is the worldwide leading cause of death in children under the age of 5. Subclinical infection affects approximately 5...
Detailed Description
Overall 10-15% of women delivering before 37 weeks have intraamniotic infection and of those delivering before 32 weeks have 50% chance. Consequently, since infection is one of the most important caus...
Eligibility Criteria
Inclusion
- Pregnant women between 23+0 weeks and 34 weeks gestation.
- Admitted with signs and symptoms of threatened PTL with positive fetal fibronectin of 200ng/mL or clinical confirmation of preterm rupture of membranes
- Singleton pregnancy
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- Women must be aged 18 years or older.
- \-
Exclusion
- Chorioamnionitis: Defined as maternal temperature was elevated to 37.8°C and two or more of the following criteria were present: uterine tenderness, malodorous vaginal discharge, maternal leucocytosis (\>15 000 cells/mm3), maternal tachycardia (\>100 beats/min) and fetal tachycardia (\>160 beats/min).
- Multiple pregnancy
- Uterine contractions \>2:10 and evidence on tocogram
- Maternal infections such as HIV and hepatitis
- Clinical suspicion of placental abruption
- Evidence of meconium stained liquor
- Fetal abnormality or growth restriction
- Abnormal fetal heart rate pattern
- Maternal pathologies in which preterm termination of pregnancy is required.
- \-
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04878978
Start Date
September 1 2021
End Date
June 1 2025
Last Update
August 18 2021
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