Preterm Rupture of Membranes Optimising Antibiotics Trial

ConditionsPPROM Preterm

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

AgeNot listed

SponsorUniversity of Melbourne

About this trial

The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.

PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \< 37+0 weeks' gestation.

Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.

Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.

Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.

Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.

This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)

Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and

Meet eligibility criteria for one or more platform domains.

Disqualifiers

Inability to consent for themselves

Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).

Maternal history consistent with loss of fluid per vagina

Evidence of a pool of fluid in the vagina on sterile speculum examination

Trial design

Design model

Parallel

Treatments tested in this trial

Erythromycin 250mg + placebo
Drug
Antibiotic.
Azithromycin 500mg + placebo
Drug
Antibiotic.
Erythromycin 250mg and Amoxicillin 500mg
Drug
Antibiotics.

Treatment groups

3,900 Participants

are divided into 3 treatment groups

Group A: Erythromycin 250mg + placeboActive comparator 1 intervention

Group B: Azithromycin 500mg + placeboActive comparator 1 intervention

Group C: Erythromycin 250mg and Amoxicillin 500mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale [PLATIPUS Core Primary Outcome]

The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for \<48 hours; 3= Neonatal unit admission for \>/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support or oxygen therapy \>/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& \<7 days; 7= Mechanical ventilation via endotracheal tube for \>/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death.

Time frame

At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).]

Secondary outcomes

Time (randomisation) to birth

Number of days from randomisation to birth.

Time frame

From randomisation to birth

Estimated antepartum/intrapartum/postpartum (< 24 hours) blood loss

Estimated antepartum/intrapartum/postpartum (\<24 hours of birth) blood loss.

Time frame

Less than 24 hours of birth.

Rate of clinical chorioamnionitis

Clinical chorioamnionitis Clinical suspicion of intra-amniotic infection such as: maternal fever (\>/= 38C AND 2 of maternal tachycardia (\> 100 beats/min), fetal tachycardia 26,27(\> 160 beats/min), uterine tenderness, purulent/malodorous amniotic fluid, maternal leukocytosis (white blood cell count \>/= 15,000/mm3) AND Antibiotics commenced for treatment for clinically suspected chorioamnionitis.

Time frame

To birth.

Rate of histological chorioamnionitis/funisitis

Histological chorioamnionitis/funisitis • Presence of inflammation in the placenta, chorion, umbilical cord and/or amnion with or without fetal inflammatory response defined according to staging of maternal (MIR) or fetal inflammatory response (FIR).

Time frame

To birth

Other outcomes

Core Secondary Outcome 1: Number of maternal deaths within 42 days postpartum

Number of mother (or birth parent) deaths within 42 days of birth.

Time frame

From birth to 42 days postpartum

Core Secondary Outcome 2: Rate of severe maternal morbidity

Maternal or pregnant person morbidity is defined as: unplanned ICU admission, sepsis, eclampsia, amniotic fluid embolism, pregnancy-related hysterectomy, severe primary postpartum haemorrhage, uterine rupture, cardiac arrest, mechanical ventilation (not for birth), stroke.

Time frame

From platform entry to 42 days postpartum

Core Secondary Outcome 3: Duration of hospitalisation

Duration of maternal or pregnant person hospitalisation, in days, after platform entry

Time frame

From date of platform entry to date of first discharge home from hospital (birth admission).

Core Secondary Outcome 4: Rate of readmission to hospital

Rate of readmission to hospital, after first discharge home from hospital, within 42 days postpartum.

Time frame

From first discharge home from hospital (birth admission) to 42 days postpartum.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Melbourne

Lead sponsor

Source ClinicalTrials.gov

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