Clinical trial NCT06917157: Latency Antibiotics for Previable Rupture Of Membranes Trial
Official title: Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Preterm Prelabor Rupture of Membranes (PPROM)
Keywords: prophylactic antibiotics
neonatal morbidity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 neonatal morbidity.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants that delivered their babies after membrane rupture
timeFrame: from baseline to day 7
Secondary outcomes:
measure: Latency, defined as the duration between rupture of membranes and delivery
timeFrame: from rupture of membranes to delivery(about 1-126 days after baseline)
measure: Number of participants that have Chorioamnionitis
timeFrame: Baseline upto delivery (about 1-126 days after baseline)
measure: Number of participants that develop sepsis
timeFrame: From baseline upto discharge (about 1-4 days post delivery)
measure: Number of maternal deaths
timeFrame: From baseline upto discharge (about 1-4 days post delivery)
measure: Number of admissions to intensive care unit (ICU)
timeFrame: From baseline upto discharge (about 1-4 days post delivery)
measure: Number of participants that develop postpartum hemorrhage
timeFrame: From baseline upto discharge (about 1-4 days post delivery)
measure: Number of participants that develop maternal postpartum infection
timeFrame: within 6 weeks of delivery
measure: Number of participants that develop maternal venous thromboembolism
timeFrame: within 6 weeks of delivery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Khalil Chahine, MD
role: PRINCIPAL_INVESTIGATOR
References: