Azithromycin for Preterm Pre-labor Rupture of Membranes

Different Azithromycin Protocols for Management of Preterm Pre-labor Rupture of Membranes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04202380

Enrollment

300

Registered

2019-12-17

Start date

2020-01-01

Completion date

2021-03-01

Last updated

2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Pre-labor Rupture of Membranes

Brief summary

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.

Interventions

DRUGAzithromycin

Patients will receive Azithromycin orally 1000 mg

DRUGAmpicillin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Days from diagnosis of preterm pre-labor rupture of membranes to delivery.	14 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026