Recruiting

Prophylactic Antimicrobial

Sponsor:

Ohio State University

Code:

NCT06396078

Conditions

Preterm Premature Rupture of Membrane

Pregnancy, High Risk

Preterm Birth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ceftriaxone 1000 MG

Clarithromycin 500mg

Metronidazole 500 mg

Ampicillin 2 GM Injection

Amoxicillin 250 MG

Study Details

Brief summary:

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.

Conditions

Preterm Premature Rupture of Membrane

Pregnancy, High Risk

Preterm Birth

Study ID

NCT06396078

Start date

Jul 18, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants randomized to the intervention group will receive the following regimen:

  • Ceftriaxone 1 g IV q 24 hours x 7 days
  • Clarithromycin 500 mg PO BID x 7 days
  • Metronidazole 500 mg PO q 12 hours x 7 days

other: Standard of care

Participants randomized to the standard care group will receive the following regimen:

  • Ampicillin 2 g IV q 6 hours x 48 hours followed by amoxicillin 250 mg q 8 hours for an additional 5 days
  • Azithromycin 1 g PO x 1 dose OR erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days

Interventions

Ceftriaxone 1000 MG

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

Clarithromycin 500mg

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

Metronidazole 500 mg

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

Ampicillin 2 GM Injection

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

Amoxicillin 250 MG

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

Azithromycin

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

Erythromycin

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)

Primary outcome measure

  • Latency [ Time Frame: From randomization to delivery ]

Central Contacts and Locations

Central contacts

Marissa Berry, MD

614-293-4780Marissa.Berry@osumc.edu

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Marissa Berry, MD

614-293-4780Marissa.Berry@osumc.edu

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 775555

Contacts

Benjamin Spires, MD

409-772-1193bpspires@UTMB.EDU

Luis D Pacheco, MD

ldpachec@utmb.edu

More Information

Sponsor

Ohio State University

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • Pregnancy
  • Preterm premature rupture of membranes
  • Latency
  • Chorioamnionitis
  • Antibiotic prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-01-27.