Azithromycin for Preterm Pre-labor Rupture of Membranes

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

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-03-01

Brief Summary

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The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management.

One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.

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Detailed Description

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Conditions

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Preterm Pre-labor Rupture of Membranes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Azithromycin 1 day group

Patients will receive Azithromycin 1000mg once orally

Group Type OTHER

Azithromycin

Intervention Type DRUG

Patients will receive Azithromycin orally 1000 mg

Ampicillin

Intervention Type DRUG

All patients will receive Ampicillin 2gm IV every 6 hours for 2 days

Azithromycin 5 days group

Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days

Group Type OTHER

Azithromycin

Intervention Type DRUG

Patients will receive Azithromycin orally 1000 mg

Ampicillin

Intervention Type DRUG

All patients will receive Ampicillin 2gm IV every 6 hours for 2 days

Azithromycin

Intervention Type DRUG

Azithromycin 500 mg orally once

Azithromycin

Intervention Type DRUG

Azithromycin 250 mg orally daily for 4 days

Interventions

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Azithromycin

Patients will receive Azithromycin orally 1000 mg

Intervention Type DRUG

Ampicillin

All patients will receive Ampicillin 2gm IV every 6 hours for 2 days

Intervention Type DRUG

Azithromycin

Azithromycin 500 mg orally once

Intervention Type DRUG

Azithromycin

Azithromycin 250 mg orally daily for 4 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Gestational age is between 28 wks and 37wks
2. Singleton living pregnancy.
3. Confirmed Premature Pre-labor rupture of membranes (PPROM).

Exclusion Criteria

1. previable rupture of membranes (\<23+6wks)
2. Multiple gestations
3. Macrolide allergy
4. patient receiving combination macrolide therapy
5. lethal fetal anomalies
6. contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No