Latency Antibiotics for Previable Rupture Of Membranes Trial (LAPROM)

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 4

Conditions: Preterm Prelabor Rupture of Membranes (PPROM)

Treatments: Drug: Administration of antibiotics non-prophylactically at 22 weeks; Drug: Administration of antibiotics prophylactically at the time of membrane rupture

Study type: Interventional

Funder types: Other

Identifiers

NCT06917157

HSC-MS-24-1285

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Administration of antibiotics prophylactically at the time of membrane rupture

Experimental group

Description:

Membrane rupture per inclusion criteria will be less than 22 weeks

Treatment:

Drug: Administration of antibiotics prophylactically at the time of membrane rupture

Administration of antibiotics non-prophylactically at 22 weeks

Active Comparator group

Treatment:

Drug: Administration of antibiotics non-prophylactically at 22 weeks