Health TrialsbyHealthPanel

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

ConditionsPreterm Premature Rupture of MembranePregnancy, High RiskPreterm Birth
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

About this trial

To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to the inpatient unit for expectant management of PPROM until delivery

Age ≥ 18 years with the ability to provide informed consent

Gestational age between 23 0/7 and 32 6/7 weeks

Disqualifiers

Having received more than one dose of any prophylactic antibiotic

Suspected or confirmed infection requiring treatment with antibiotics

Allergy or contraindication to an antibiotic in either arm

Maternal immunosuppression

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ceftriaxone 1000 MG

    Drug

    Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)

  • Clarithromycin 500mg

    Drug

    Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)

  • Metronidazole 500 mg

    Drug

    Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)

  • Ampicillin 2 GM Injection

    Drug

    Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)

  • Amoxicillin 250 MG

    Drug

    Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)

  • Azithromycin

    Drug

    Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)

  • Erythromycin

    Drug

    Erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days (in addition to ampicillin and amoxicillin)

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 3 interventions
Group B: Standard of careOther 4 interventions

Trial outcomes

Primary outcomes

1

Latency

Latency will be measured in hours, and also reported as days for clinical interpretability.

Time frame
From randomization to delivery

Secondary outcomes

1

Neonatal outcome composite checklist

Includes neonatal sepsis, respiratory distress syndrome, any mechanical ventilation, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, stillbirth, or neonatal death

Time frame
From birth to up to 6 weeks postpartum
2

Endometritis

Diagnosed If the patient develops two of the following 1) oral body temperature ≥101°F at any time, or a temperature of ≥100.4 °F 24 hours after delivery, 2) maternal tachycardia that parallels the temperature, 3) uterine tenderness, 4) purulent vaginal discharge, or 5) associated findings with advanced endometritis (dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment)

Time frame
From birth to up to 6 weeks postpartum
3

Surgical site infection

Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Intraabdominal abscess may or may not be present. Wound hematoma, seroma, or incisional breakdown alone in the absence of the above signs does not constitute infection.

Time frame
From birth to up to 6 weeks postpartum
4

Individual clinical infections

Time frame
From birth to up to 6 weeks postpartum

Other outcomes

Sponsors and contacts

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

Ohio State University

Lead sponsor

Source ClinicalTrials.gov
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