Latency Antibiotics for Previable Rupture Of Membranes Trial (LAPROM)

Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial

The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.

Study Overview

• Status: Withdrawn
• Conditions: Preterm Prelabor Rupture of Membranes (PPROM)
• Intervention / Treatment: Drug: Administration of antibiotics prophylactically at the time of membrane rupture; Drug: Administration of antibiotics non-prophylactically at 22 weeks

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preterm premature rupture of membranes at less than 22 weeks.
• Membrane rupture had occurred within 36 hours of randomization.
• Cervical dilatation is 3 cm or less (on visual or clinical examination).
• 4 or fewer contractions in the 60-minute monitoring period before randomization.
• Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
• Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.

Exclusion Criteria:

• Nonreasoning fetal testing
• Vaginal bleeding
• Maternal or fetal indication for immediate delivery
• Cervical cerclage in place
• Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
• Allergy to Penicillins or Azithromycin
• Febrile illness requiring antibiotics
• Placenta previa
• Multifetal gestation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of antibiotics prophylactically at the time of membrane rupture; Membrane rupture per inclusion criteria will be less than 22 weeks	Drug: Administration of antibiotics prophylactically at the time of membrane rupture; Participants will receive the antibiotic regimen: Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours; Day 2: Intravenous Ampicillin 2 g every 6 hours; Days 3-7: Oral Amoxicillin 500 mg every 8 hours
Active Comparator: Administration of antibiotics non-prophylactically at 22 weeks	Drug: Administration of antibiotics non-prophylactically at 22 weeks; Participants will receive latency antibiotics starting 22 weeks 0 days: Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours; Day 2: Intravenous Ampicillin 2 g every 6 hours; Days 3-7: Oral Amoxicillin 500 mg every 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that delivered their babies after membrane rupture	from baseline to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency, defined as the duration between rupture of membranes and delivery		from rupture of membranes to delivery(about 1-126 days after baseline)
Number of participants that have Chorioamnionitis		Baseline upto delivery (about 1-126 days after baseline)
Number of participants that develop sepsis		From baseline upto discharge (about 1-4 days post delivery)
Number of maternal deaths		From baseline upto discharge (about 1-4 days post delivery)
Number of admissions to intensive care unit (ICU)		From baseline upto discharge (about 1-4 days post delivery)
Number of participants that develop postpartum hemorrhage	postpartum hemorrhage could occur during the following: Transfusion; Non-elective hysterectomy; Use of two or more uterotonics other than oxytocin; Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization and hypogastric ligation, balloon tamponade; Curettage	From baseline upto discharge (about 1-4 days post delivery)
Number of participants that develop maternal postpartum infection	Infection is defined as one of the following: Clinical diagnosis of endometritis; Wound reopened for hematoma, seroma, infection or other reasons; Cellulitis requiring antibiotics; Pneumonia; Pyelonephritis; Bacteremia unknown source; Septic pelvic thrombosis	within 6 weeks of delivery
Number of participants that develop maternal venous thromboembolism		within 6 weeks of delivery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Khalil Chahine, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prophylactic antibiotics; neonatal morbidity
• Additional Relevant MeSH Terms: Urogenital Diseases; Wounds and Injuries; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Fetal Membranes, Premature Rupture; Rupture; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: HSC-MS-24-1285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No