Latency Antibiotics for Previable Rupture Of Membranes Trial (LAPROM)

April 29, 2026 updated by: Khalil Chahine, The University of Texas Health Science Center, Houston

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants that delivered their babies after membrane rupture
Time Frame: from baseline to day 7
from baseline to day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Latency, defined as the duration between rupture of membranes and delivery
Time Frame: from rupture of membranes to delivery(about 1-126 days after baseline)
from rupture of membranes to delivery(about 1-126 days after baseline)
Number of participants that have Chorioamnionitis
Time Frame: Baseline upto delivery (about 1-126 days after baseline)
Baseline upto delivery (about 1-126 days after baseline)
Number of participants that develop sepsis
Time Frame: From baseline upto discharge (about 1-4 days post delivery)
From baseline upto discharge (about 1-4 days post delivery)
Number of maternal deaths
Time Frame: From baseline upto discharge (about 1-4 days post delivery)
From baseline upto discharge (about 1-4 days post delivery)
Number of admissions to intensive care unit (ICU)
Time Frame: From baseline upto discharge (about 1-4 days post delivery)
From baseline upto discharge (about 1-4 days post delivery)
Number of participants that develop postpartum hemorrhage
Time Frame: From baseline upto discharge (about 1-4 days post delivery)

postpartum hemorrhage could occur during the following:

  1. Transfusion
  2. Non-elective hysterectomy
  3. Use of two or more uterotonics other than oxytocin
  4. Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization and hypogastric ligation, balloon tamponade
  5. Curettage
From baseline upto discharge (about 1-4 days post delivery)
Number of participants that develop maternal postpartum infection
Time Frame: within 6 weeks of delivery

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
Time Frame: within 6 weeks of delivery
within 6 weeks of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khalil Chahine, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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