Azithromycin for Preterm Pre-labor Rupture of Membranes

Study Overview
=================
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.

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

Conditions
-----------------
Preterm Pre-labor Rupture of Membranes

Intervention / Treatment
-----------------
* Drug: Azithromycin
* Drug: Ampicillin
* Drug: Azithromycin
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Azithromycin 1 day group<br>Patients will receive Azithromycin 1000mg once orally | Drug: Azithromycin<br>* Patients will receive Azithromycin orally 1000 mg<br>Drug: Ampicillin<br>* All patients will receive Ampicillin 2gm IV every 6 hours for 2 days<br>|
| Other: Azithromycin 5 days group<br>Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days | Drug: Azithromycin<br>* Patients will receive Azithromycin orally 1000 mg<br>Drug: Ampicillin<br>* All patients will receive Ampicillin 2gm IV every 6 hours for 2 days<br>Drug: Azithromycin<br>* Azithromycin 500 mg orally once<br>Drug: Azithromycin<br>* Azithromycin 250 mg orally daily for 4 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days from diagnosis of preterm pre-labor rupture of membranes to delivery. |  | 14 days |