Preterm Prelabor Rupture of Membranes (PPROM)Phase 4LAPROMNCT06917157
Latency Antibiotics for Previable Rupture Of Membranes Trial
A Phase 4 study testing Administration of antibiotics prophylactically at the time of membrane rupture and Administration of antibiotics non-prophylactically at 22 weeks in people with Preterm Prelabor Rupture of Membranes (PPROM), run by The University of Texas Health Science Center, Houston.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Prelabor Rupture of Membranes (PPROM)
- What is being tested?
- Administration of antibiotics prophylactically at the time of membrane rupture and Administration of antibiotics non-prophylactically at 22 weeks
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 May 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Febrile illness requiring antibiotics
- Placenta previa
- Multifetal gestation
About this study
Official title: 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.
- Being tested
- Administration of antibiotics prophylactically at the time of membrane rupture, Administration of antibiotics non-prophylactically at 22 weeks
- Keywords
- prophylactic antibiotics, neonatal morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of antibiotics prophylactically at the time of membrane ruptureDrug
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
Administration of antibiotics non-prophylactically at 22 weeksDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Administration of antibiotics prophylactically at the time of membrane rupture | Experimental | Membrane rupture per inclusion criteria will be less than 22 weeks Receives: Drug: Administration of antibiotics prophylactically at the time of membrane rupture |
| Administration of antibiotics non-prophylactically at 22 weeks | Active comparator | Not described Receives: Drug: Administration of antibiotics non-prophylactically at 22 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that delivered their babies after membrane rupture
Measured: from baseline to day 7
Secondary outcomes (8)
Latency, defined as the duration between rupture of membranes and delivery
Measured: from rupture of membranes to delivery(about 1-126 days after baseline)
Number of participants that have Chorioamnionitis
Measured: Baseline upto delivery (about 1-126 days after baseline)
Number of participants that develop sepsis
Measured: From baseline upto discharge (about 1-4 days post delivery)
Number of maternal deaths
Measured: From baseline upto discharge (about 1-4 days post delivery)
Number of admissions to intensive care unit (ICU)
Measured: 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
Measured: 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
Measured: within 6 weeks of delivery
Number of participants that develop maternal venous thromboembolism
Measured: within 6 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Why it stopped: PI has decided to end study due to changes in Texas law and no participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Prelabor Rupture of Membranes (PPROM)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalil Chahine, The University of Texas Health Science Center, Houston
- Investigators
- Khalil Chahine, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917157
- Sponsor's protocol ID
- HSC-MS-24-1285
- Acronym
- LAPROM
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial
- ClinicalTrials.gov ID
- NCT06917157
- Acronym / sponsor ID
- LAPROM / HSC-MS-24-1285
- Keywords
- prophylactic antibiotics, neonatal morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has decided to end study due to changes in Texas law and no participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of antibiotics prophylactically at the time of membrane rupture | Experimental | Drug: Administration of antibiotics prophylactically at the time of membrane ruptureMembrane rupture per inclusion criteria will be less than 22 weeks |
| Administration of antibiotics non-prophylactically at 22 weeks | Active comparator | Drug: Administration of antibiotics non-prophylactically at 22 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of antibiotics prophylactically at the time of membrane ruptureParticipants 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 | Drug | Administration of antibiotics prophylactically at the time of membrane rupture |
| Administration of antibiotics non-prophylactically at 22 weeksParticipants 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 | Drug | Administration of antibiotics non-prophylactically at 22 weeks |
Primary outcome
Number of participants that delivered their babies after membrane rupture
Time frame: from baseline to day 7
8 secondary outcomes
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)
Number of participants that have Chorioamnionitis
Time frame: 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)
Number of maternal deaths
Time frame: 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)
Number of participants that develop postpartum hemorrhage
Time frame: 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
Number of participants that develop maternal venous thromboembolism
Time frame: within 6 weeks of delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalil Chahine, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Administration of antibiotics prophylactically at the time of membrane rupture and Administration of antibiotics non-prophylactically at 22 weeks in people with Preterm Prelabor Rupture of Membranes (PPROM), run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that delivered their babies after membrane rupture (time frame: from baseline to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.