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Completed

NCT Number: NCT04202380

Azithromycin for Preterm Pre-labor Rupture of Membranes

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Azithromycin

Drug

Patients will receive Azithromycin orally 1000 mg

Ampicillin

Drug

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

Primary outcomes

  1. Days from diagnosis of preterm pre-labor rupture of membranes to delivery.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.