Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes

NCT05328817 | Unknown

• 1 other identifier: 22-01-FB-0001
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1. To examine the latency period according to antibiotic regimens (erythromycin iv for two days followed by orally for 5 days vs. azithromycin iv for 2 days followed by 5 days orally). Aim 2. To examine the latency period according to races stratified by antibiotic regimens. Aim 3: To examine if there is a difference in neonatal morbidity and mortality stratified by antibiotic regimen.

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• Latency Period

  The time interval between the first antibiotic dose to time of delivery.

  At delivery

Study Arms (2)

Erythromycin

EXPERIMENTAL

Receive 1) erythromycin 250 mg iv every 6 hours for 48 hours followed by 333 mg orally (pills) every 8 hours for 5 days

Drug: Antibiotics

Azithromycin

EXPERIMENTAL

Receive azithromycin 500 mg iv daily for 48 hours followed by 500 mg orally (pills) for 5 days.

Drug: Antibiotics

Interventions

Antibiotics DRUG

In the absence of labor, broad-spectrum antibiotics (often called latency antibiotics) are recommended for women with PPROM less than 34 weeks to reduce chorioamnionitis, prolong latency, and decrease neonatal sepsis (12,13).

Also known as: Latency antibiotics, Broad-spectrum antibiotics

Azithromycin; Erythromycin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• PPROM from 22 weeks 0 days to 31 weeks 6 days at Sentara Norfolk General Hospital
• Membrane rupture within 36 hours of randomization, cervical dilation 3 cm or less, and 4 or fewer contractions in the 60-minutes monitoring before randomization

You may not qualify if:

• Non-reassuring fetal heart tracing
• Vaginal bleeding
• Indications for delivery
• Received any antibiotic therapy within 7 days other than initiation of Ampicillin treatment as part of latency antibiotics prior to transfer to Sentara Norfolk General Hospital
• Allergy to penicillin, erythromycin, or azithromycin

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Related Publications (24)

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• Mercer BM, Moretti ML, Prevost RR, Sibai BM. Erythromycin therapy in preterm premature rupture of the membranes: a prospective, randomized trial of 220 patients. Am J Obstet Gynecol. 1992 Mar;166(3):794-802. doi: 10.1016/0002-9378(92)91336-9.

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• Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, Rabello YA, Meis PJ, Moawad AH, Iams JD, Van Dorsten JP, Paul RH, Bottoms SF, Merenstein G, Thom EA, Roberts JM, McNellis D. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997 Sep 24;278(12):989-95.

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MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Tetsuya Kawakita, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetsuya Kawakita, MD

CONTACT

757-446-7900; kawakit@evms.edu

Kristin Ayers, MPH

CONTACT

7574460579; ayerskl@evms.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In order to maintain balanced groups, block randomization will be used. Pregnant women will be randomized in blocks of 6 with a total number of blocks to be 40. This will be conducted using STATA16 software, which will generate random permutations of sequential IDs of eligible study participants and their assignment to the treatment arms. This will be transferred to the REDCap in which a database will be created to facilitate random assignment during recruitment while maintaining concealment of randomization.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share