Latency Antibiotics for Previable Rupture Of Membranes Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Prelabor Rupture of Membranes (PPROM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of antibiotics prophylactically at the time of membrane rupture

Membrane rupture per inclusion criteria will be less than 22 weeks

Group Type EXPERIMENTAL

Administration of antibiotics prophylactically at the time of membrane rupture

Intervention Type DRUG

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 weeks

Group Type ACTIVE_COMPARATOR

Administration of antibiotics non-prophylactically at 22 weeks

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No