Improving management of preterm premature rupture of membranes with antibiotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a new antibiotic regimen consisting of ceftriaxone, clarithromycin, and metronidazole compared to the standard treatment of ampicillin/amoxicillin and azithromycin or erythromycin for pregnant individuals with preterm premature rupture of membranes (PPROM). The study aims to prolong pregnancy and reduce adverse perinatal outcomes by administering these antibiotics during hospitalization for expectant management. Participants will be randomly assigned to receive either treatment for a duration of seven days, and outcomes will be monitored to assess the efficacy of the new regimen. The trial is designed as an unblinded pragmatic randomized controlled trial to reflect real-world clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
  Columbus, Ohio, United States Recruiting
• University of Texas Medical Branch
  Galveston, Texas, United States Recruiting

Study contacts

• Principal investigator: Marissa Berry, MD — Ohio State University
• Study coordinator: Marissa Berry, MD
• Email: Marissa.Berry@osumc.edu
• Phone: 614-293-4780

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Selective antibiotics when symptoms develop versus universal antibiotics for preterm neonates

  In preterm babies at risk for sepsis, researchers test whether giving antibiotics only to those who show symptoms is as safe as giving antibiotics to all at-risk babies in the first week of life.

  Recruiting at 9 sites Phase 3 Indian Council of Medical Research · Chandigarh, Chandigarh and 8 other locations · NCT06377397

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

  Recruiting at 2 sites Makerere University · Kampala and 1 other locations · NCT07844876

• Cervical stiffness test to help predict preterm birth in at-risk pregnant women

  A simple cervical stiffness test using the Pregnolia device is being studied to see if it can better identify women with threatened preterm labor who are likely to give birth soon.

  Recruiting Pregnolia AG · Prague · NCT07840235

• Prenatal education to reduce environmental exposures during pregnancy

  Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.

  Recruiting at 2 sites The University of Texas Medical Branch, Galveston · Galveston, Texas and 1 other locations · NCT07758114

• How doctors and nurses decide about bed rest in pregnancy

  This study tests a plan to stop routinely restricting activity or bed rest during pregnancy to see if providers accept it, find it appropriate, and change how often they recommend it for women at risk of preterm birth.

  Recruiting at 2 sites University of Pennsylvania · Philadelphia, Pennsylvania and 1 other locations · NCT07698483

• How cervical ultrasound settings affect AI prediction of preterm birth

  This study tests whether an AI model for predicting preterm birth performs differently when cervical ultrasound images are taken with different imaging settings.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07598097

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.