Premature Rupture Membranes and tPTL: a Personalised Approach (PROMPT)

NCT04878978 | Unknown

• 1 other identifier: C&W20/21
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

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 50% of women giving birth before 32 weeks. Infection contributes to significant neonatal morbidity and mortality. Antibiotics such as erythromycin is currently used to treat women who present with preterm rupture of membranes. While this has shown short-term improvement in neonatal morbidity, it has not had any impact in reducing the perinatal mortality and also little effect on the health of the children at age seven. Some antibiotics such as co-amoxiclav has not shown to be effective in delaying delivery and some studies have shown that antibiotics increases rather than reduces the risk of cerebral palsy. Many women do not display signs of infection and the underlying bacteria is multifactorial (bacterial vaginosis, trichomoniasis, gonorrhoea, Chlamydia, ureaplasma, Group B streptococcal and E. Coli) and remains a diagnostic challenge. The only available clinical approach is to test the sample of amniotic fluid for bacteria and small case series have shown prolongation of pregnancy when accurately targeted antibiotic treatment is used. This research aims to prove that targeted antibiotic therapy results in a greater prolongation of pregnancy than standard management for women with preterm prelabour rupture of membranes (PPROM) and/or threatened preterm labour (tPTL). Women will be randomised to standard care versus BioFire directed antibiotic treatment in addition to standard care. Investigators will use the BioFire point of care testing to identify the presence of infection and identify with anti-microbial resistance genes the bacteria possess to guide the antibiotic treatment. To be certain that the presence of infection is detected the investigators will use PCR to test the amniotic fluid for IL-6 and white cell count.

Conditions

Preterm Rupture of Membranes; Threatened Preterm Labor

Outcome Measures

Primary Outcomes (1)

• The length of latency of women receiving amniocentesis with BioFire filmArray POC test guided antibiotic selection compared to those receiving standard treatment.

  Days

  4 years

Secondary Outcomes (9)

• Maternal outcome

  4 years

• Neonatal outcome

  4 years

• Microbiota and inflammatory marker endpoints

  4 years

• Patient based endpoints

  5 years

• Timing of birth

  4 years

Study Arms (2)

Routine care

ACTIVE COMPARATOR

Women who present with PPROM or threatened PTL and have routine care

Other: Routine care without amniocentesis

Amniocentesis and biofire directed antibiotic use

EXPERIMENTAL

Women who present with PPROM or threatened PTL and randomised to amniocentesis and biofire directed antibiotic treatment

Diagnostic Test: Amniocentesis

Interventions

Amniocentesis DIAGNOSTIC_TEST

Amniocentesis will be used to sample the amniotic fluid for Biofire detection of microorganism and to direct antibiotic treatment

Amniocentesis and biofire directed antibiotic use

Routine care without amniocentesis OTHER

Routine clinical care

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Amniocentesis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single centre open labelled randomised study.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 10, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 18, 2021

Record last verified: 2021-04