Azithromycin and Ampicillin for Late PPROM
Phase: PHASE4
Conditions: Pregnancy Complications, Infectious, Premature Birth, Neonatal Diseases and Abnormalities, Antibiotic Prophylaxis, Latency Period, Prematurity
Sponsor: Sheba Medical Center

SHEBA-05-1755-24-NG-CTIL
 
 
 
 
 
 
 
 
Official Title: 
 
Azithromycin and Ampicillin for Late PPROM  
A Randomized Controlled Trial (ALPRO) 
 
 
NCT Number: 
[NCT ID not yet assigned] 
 
Unique Protocol ID: 
SHEBA-05-1755-24-NG-CTIL 
 
Secondary Protocol ID: 
MOH_2025-04-30_014029 
 
Date of Document: 
June 1, 2025 
 
Principal Investigator: 
Dr. Noa Gonen 
 
Sponsor: 
Sheba Medical Center 
 
 
 
 
 
 
 

SHEBA-05-1755-24-NG-CTIL
 
 
 
Azithromycin and Ampicillin for Late PPROM- A Randomized Control Trial 
 
 
Introduction: 
Preterm premature rupture of membranes (PPROM) complicates 1–3% of all pregnancies and is 
the presenting symptom in approximately 30% of all preterm deliveries 1. PPROM is associated 
with potential maternal, fetal, and neonatal morbidity and mortality 2,3. Given the strong 
association between perinatal outcome and gestational age at birth, most of the interventions 
studied aimed at prolonging pregnancy after the rupture of membranes, to improve neonatal 
outcomes.  
The management of pregnancies complicated by PPROM < 32 weeks of gestation has been well 
studied and includes the administration of corticosteroids and prophylactic antibiotic therapy. In 
a systematic review of 22 randomized trials involving over 6800 women3, antibiotic use was 
associated with significant reductions in chorioamnionitis (RR 0.57, 95% CI 0.37 to 0.86), 
neonatal infection (RR 0.68, 95% CI 0.53 to 0.87), use of surfactant (RR 0.83, 95% CI 0.72 to 
0.96), oxygen therapy (RR 0.88, 95% CI 0.81 to 0.96), and abnormal cerebral ultrasound scan 
before discharge from hospital (RR 0.82, 95% CI 0.68 to 0.98) and numbers of babies born within 
48 hours (RR 0.71, 95% CI 0.58 to 0.87) and seven days (RR 0.80, 95% CI 0.71 to 0.90) of 
randomization. Hence, the goal of antibiotic treatment is to reduce the frequency of maternal 
and fetal infection, prolong latency, and reduce neonatal consequences of prematurity. 
Antibiotic regimen for PPROM in the early preterm (<32 weeks of gestation) is widely used 
according to the Mercer protocol regimen. This regimen comprised Ampicillin and Erythromycin 
overall for seven days4 Ampicillin targets group B Streptococcus (GBS) and some anaerobic 
bacteria (and to a lesser extent aerobic, gram-negative bacilli), erythromycin (or azithromycin) 
targets Ureaplasma and mycoplasma and for latency. 
Traditionally, immediate delivery was recommended for all women with ruptured membranes at 
34.0 weeks of gestation or greater. However, numerous studies have demonstrated that 
neonates born at this gestational age, while classified as late preterm, still face significant risks 
for neonatal complications. These infants remain at an increased risk for various morbidities, 
highlighting that even late preterm birth carries considerable health concerns for the newborn 5.  
Consequently, the expectant management of late PPROM has been tested in several studies 6,7 
including a large, randomized trial involving 1,839 women, which suggested benefits of 
expectant management. Rates of neonatal sepsis and a composite of neonatal morbidity and 

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mortality rates were not significantly different when managed expectantly versus immediately 
delivered 7 Furthermore, neonates born to mothers who were immediately delivered after 
PPROM experienced increased rates of RDS, mechanical ventilation, and longer NICU stay 
compared with neonates born after expectant management. Accordingly, expectant 
management of late PPROM has become common practice today 8. 
The administration of prophylactic ampicillin to patients with late preterm prelabor rupture of 
membranes (PPROM) is standard practice to prevent group B streptococcus (GBS) infection. 
However, the optimal antibiotic regimen to effectively prolong latency remains unclear. A recent 
retrospective study9 has suggested that a combination of penicillin for GBS prophylaxis and 
roxithromycin (150 mg twice daily for 10 days) in women with late preterm PPROM may improve 
neonatal outcome but did not demonstrate a decrease in neonatal sepsis. 
Our study aims to compare the effect of two antibiotic regimens, Ampicillin alone (our current 
usual care) vs. Ampicillin and azithromycin, on a composite of neonatal adverse outcomes.  
Methods  
Design: This study will be a multicenter randomized controlled trial comparing two different 
Antibiotic regimens for the treatment of preterm premature rupture of membranes at ≥ 34 
weeks. 
Population: women aged 18-50 presenting with premature rupture of membranes between 
34.0 and 36.4 weeks of gestation will be eligible.  
Study length: 2 years 
Inclusion Criteria: 
• Maternal age 18-50 
• Premature rupture of membranes  
• Gestational age 34.0 and 36.4 weeks  
• Singleton pregnancy 
 
Exclusion Criteria: 
• Multiple gestations  

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• Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or 
regular uterine construction of more than 4 in 10 minutes)  
• Meconium stain amniotic fluid  
• Non-reassuring fetal heart rate or status  
• Maternal or fetal indication for labor:  
o Suspected Chorioamnionitis  
o Suspected placental abruption  
o Any maternal morbidity requiring labor 
• Cervical cerclage in place.  
• Major fetal malformation or known chromosomal abnormalities.  
• Stillbirth.  
• Sensitivity to Macrolides Antibiotics 
Primary Outcome: 
• A composite of neonatal adverse outcomes including one or more of the following:  
o Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula  
o Supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at 
least 4 continuous hours,  
o Extracorporeal membrane oxygenation (ECMO)  
o Mechanical ventilation.  
o Neonatal sepsis (defined as positive blood culture)  
o Hypoglycemia requiring treatment 
o Hyperbilirubinemia requiring phototherapy 
o Stillbirth and neonatal death within 72 hours after delivery  
 
Secondary outcomes: 
Infant outcomes: 
• Components of the Composite Outcomes  
• Severe respiratory morbidity (need for high flow nasal cannula/CPAP for ≥12 hours or 
mechanical ventilation or neonatal death) 
• Need for resuscitation.  
• RDS (defined as the presence of clinical signs of respiratory distress (tachypnea, 
retractions, flaring, grunting, or cyanosis), with a requirement for supplemental oxygen 

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with a fraction of inspired oxygen of more than 0.21 and a chest radiograph showing 
hypoaeration and reticulogranular infiltrates) 
• Surfactant use  
• Transient tachypnea of the newborn (defined as tachypnea in the absence of chest 
radiography or with a radiograph that was normal or showed signs of increased perihilar 
interstitial markings and resolved within 72 hours)  
• Necrotizing enterocolitis  
• IVH grade 3 or 4  
• Feeding intolerance  
• NICU stay > 3 days.  
• Duration of NICU 
• Pneumothorax 
• meconium aspiration syndrome 
• asphyxia 
• periventricular leukomalacia 
• convulsions 
• Neonatal death 
• Placental histopathology abnormalities 
• Placental culture results  
 
Maternal outcomes: 
• Latency from randomization to delivery 
• Antenatal corticosteroids completed 
• Placental abruption 
• Intrapartum fever 
• Chorioamnionitis (defined as uterine tenderness and/or maternal fever related to 
suspected uterine infection)  
• Bacteremia  
• Unplanned cesarean delivery  
• Postpartum endometritis  
• Postpartum wound infection/dehiscence  
• Composite adverse maternal outcome including any of the following: bacteremia, need 
for ICU admission, hysterectomy, or need for drainage or relaparotomy.  
• Length of postpartum stay  
• Breastfeeding  

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• Need for readmission 
• Antepartum hemorrhage 
• uterine rupture 
• umbilical cord prolapse 
• Procalcitonin level at first 24 hours from admission 
• SFLT-1/PLGF ratio at first 24 hours from admission 
 
Study Design: 
Women presenting with premature rupture of membranes between 34.0 and 36.4 weeks of 
gestation evaluated in our ER will be examined. PPROM will be diagnosed based on history and 
physical examination: patients presented with a history of leaking fluid will be checked for 
pooling of amniotic fluid on sterile speculum examination. In case of doubt, AmniSure immune 
chromatography methods will be used to detect trace amounts of placental alpha microglobulin-
1 protein in vaginal fluid and to confirm the diagnosis. GBS culture will be taken for all 
individuals.  
Following the diagnosis of PPROM, women are admitted to the high-risk department for 
expectant management. Within the first 24 hours from admission, eligible women will be offered 
to participate in the study and go through randomization. 
Recruitment: will take place at the HRP department or ER, Within the first 24 hours from 
admission, by one of the research team members 
Ø The control group will be treated with the current standard care protocol (intravenous 
ampicillin 2 g every 6 h for 48 h, followed by oral amoxicillin 500 mg every 8 h for an 
additional five days) 
Ø The Study group (Azithromycin group) will be treated with intravenous ampicillin 2 g 
every 6 h for 48 h, followed by oral amoxicillin 500 mg every 8 h for an additional five 
days, and IV azithromycin 1 gram once. 
 
In case a patient is allergic to penicillin, treatment will be per the ACOG recommendations (10) 
as follows: 

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Ø Patients at low risk for anaphylaxis will be treated with IV cefazolin 2g load, then 1 g IV 
every 8 hours until 48 hours, followed by oral cefalexin 500 mg every 6 hours for 
additional five days. 
Ø Patients at high risk for anaphylaxis: 
o If known as Clindamycin susceptible GBS: patients will be treated with IV 
Clindamycin 900 mg IV every 8 hours for 48 hours followed by oral clindamycin 
300 mg every 8 hours for additional five days. 
o If known as Clindamycin resistant GBS (or unknown): patients will be treated 
with IV Vancomycin 2 gr load, then 1 gr every 12 hours for 24 hours followed by 
oral vancomycin 15mg/kg/dose every 12 hours for additional five days. 
Ø Patients with GBS bacteriuria at any given time during the index pregnancy will be 
considered GBS POSITIVE 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization: subjects will be randomly assigned to either control or latency group in a 1:1 
ratio stratified by center and gestational age <35 weeks and ≥35 weeks. Written informed 
consent will be obtained from all participants.  
allergic to penicillin 
low risk for 
anaphylaxis 
high risk for 
anaphylaxis 
IV cefazolin 2g load, then 
1 g IV every 8 hours until 
48 hours followed by oral 
cefalexin 500 mg every 6 
hours for additional five 
days 
Clindamycin 
susceptible GBS 
Clindamycin-resistant 
GBS or unknown 
IV Clindamycin 900 
mg IV every 8 hours 
for 48 hours followed 
by oral clindamycin 
300 mg every 8 hours 
for additional five 
days 
IV Vancomycin 2 gr load, 
then 1 gr every 12 hours 
for 24 hours followed by 
oral vancomycin 
15mg/kg/dose every 12 
hours for additional five 
days 

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All participants will be hospitalized from the time of diagnosis until delivery.  
Expectant management will include:  
• Maternal monitoring for signs of infection including vital signs (*3 per day) clinical 
parameters (presence of uterine tenderness, frequency of contractions) (once daily) 
blood analysis of CBC and CRP (every 3 days) until labor. 
• Fetal monitoring for signs of infection including heart rate monitoring *2 daily. 
• Antenatal corticosteroids (ANC) – will be given upon admission in patient between 34.0 
and 36.0 weeks of gestation. 
o  In case the patient has previously received ANC during pregnancy or has been 
diagnosed with pre-gestational diabetes ANC will not be given.  
o For patients with gestational diabetes, the decision regarding ANC administration 
will be made by the attending physician 
• Screening for GBS infection (via recto-vaginal swab) will be performed on all women 
upon admission. Women who test positive for GBS will also receive prophylactic 
treatment intrapartum. Women with GBS bacteriuria during pregnancy will be 
considered as GBS positive and receive prophylactic treatment intrapartum 
• Tocolysis is not administered in these cases.  
• Ultrasound is performed to evaluate the fetal presentation, growth, placental location, 
and amniotic fluid volume.  
• Labor: 
o Mode of delivery will be chosen on obstetric indications. 
o Labor will be induced at 37 weeks of gestation or when mandated according to 
usual indications. 
• After labor:  
o A placental biopsy will be sent for culture 
o The remainder of the placenta will be sent for histopathological examination 
 
Sample size calculation 
Based on the results of previous studies(7,11) the rate of the primary composite during the late 
preterm period is estimated to be 50%. we estimated that 296 women would provide a power of 
at least 80% to detect a relative decrease of 33% in the rate of the primary outcome, from 50% 
in the control group to 33.5% in the azithromycin group, with a two-sided type I error rate of 5%.  
We will recruit additional 15 patients, to account for a predicted 5% loss to follow-up.  (Total of 
311).  

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Ethics 
Informed consent 
 All prospective study candidates will be given a full explanation of the study, allowed to read, 
and provided with the opportunity to ask any questions. Once all questions have been answered 
and the investigator is assured that the individual understands the requirements of the study, 
the subject will be signing informed consent. The investigator shall provide a copy of the 
informed consent. 
Institutional Review Board 
Prior to the initiation of the study, the primary investigator at each center will obtain approval 
for the research protocol of the IRB. 
Subject confidentiality  
Each participant will be assigned a unique study number to maintain anonymity before the data 
collection. A record of the participants will be kept at the study site for each assigned study 
number. The access to personal information will be limited to the investigators alone.  
The participants will not be de-identified as the results of the study are published in medical 
journals or scientific meetings. 
 
 
Data handling and record keeping 
The research personnel will perform data collection from the participant's electronic medical 
records. Data will be collected from the patient's enrollment until six weeks postpartum.  
Data will be digitally encrypted by using the RedCap system. During the study, the investigators 
will retain copies of the study protocol, the approved protocol, and all other supporting 
documentation related to the project. After the completion of the study, the de-identified 
information of the patients will remain available and may be used for future research projects.  
Quality Control and Assurance 
The principal investigators will go through all the files and the data collected to validate their 
accuracy and completion. The verification will be by self-assessment. 
 
 
 

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Literature review 
 
Results 
Primary outcome 
Exclusion 
inclusion 
Population 
Intervention 
Design 
Publication 
Title 
Author 
In the GBS-negative cohort, 
the antibiotic group had less 
frequent primary outcome 
(44.5% vs 54.5%; P=.03), 
respiratory distress (40.8% vs 
50.6%; P=.03), overall sepsis 
(8.4% vs 15.6%; P=.01), 
pneumonia (2.9% vs 7.0%; 
P=.04), and other 
morbidities. Among GBS-
negative women, significant 
pregnancy prolongation was 
seen with antibiotics 
(P<.001). 
Composite of   fetal 
or infant death, RDS, 
severe IVH, stage 2 
or 3 necrotizing 
enterocolitis, or 
sepsis within 72 
hours of birth. These 
perinatal morbidities 
were also evaluated 
individually and 
pregnancy 
prolongation was 
assessed. 
NRFHR, 
,Vaginal 
Bleeding,   
indication for 
delivery, 
cerclage, ABX 
therapy within 
5 days or ANC 
therapy within 
7 days 
PPROM  
24 – 32w ,  
cervical 
dilatation< 
3cm or 
less , < 4 
UC in 60 
min NST. 
614 
ABX 
(Amoxicillin 
and 
Erythromycin 
foe 7 days 
overall) Vs 
Placebo 
RCT , 
double 
blinded 
Jama 1997 
 
Antibiotic 
therapy for 
reduction of 
infant 
morbidity 
after PPROM. 
A randomized 
controlled 
trial 
Mercer 
Neonatal sepsis - 2.6% in  IoL 
Vs  4.1% in  EM  (RR 0.64; CI 
0.25 to 1.6). 
RDS in 7.8% of IoL Vs 6.3% in  
EM (RR 1.3; CI 0.67 to 2.3) 
CS  in 13% of  IoL Vs 14% of 
EM (RR 0.98; CI 0.64 to 1.50). 
risk for chorioamnionitis was 
reduced in the IoL group. No 
serious adverse events were 
reported. 
Neonatal Sepsis 
MCBA twins ; 
NRFHR; 
meconium; 
infection; 
major fetal 
anomalies; 
HELLP 
syndrome; or 
severe PET 
PPROM 
34-36.6 
not in 
labor 
536 
Induction of 
labor Vs 
Expectent 
management 
to reduces 
neonatal 
sepsis 
multice
nter, 
RCT l in 
The 
Netherl
ands 
PLOS 
medicine 
2012 
PPROXEMIL 
van der 
Ham 
Results 
Primary outcome 
Exclusion 
inclusion 
Population 
Intervention 
Design 
Publication 
Title 
Author 
Primary outcome of Neonatal 
sepsis - NO difference!  2% of 
immediate birth and 3% of 
expectant management  [RR] 
0·8, p=0.37.  composite 
neonatal - No difference!    
8%  of immediate delivery 7% 
of expectant management 
(RR 1·2, p=0·32). RDS - higher 
in immediate delivery 8% vs 
5%, RR 1·6; p=0·008. 
Mechanical ventilation - 12%  
vs 9%, RR 1·4, p=0·02 ICU  4 d 
vs 2 d p<0·0001. Expectant 
management  had higher 
risks of antepartum or 
intrapartum haemorrhage 
Neonatal sepsis 
established 
labour, 
chorioamnioniti
s, meconium 
staining, any 
other 
contraindicatio
n to continuing 
the pregnancy. 
GBS was not an 
exclusion 
criterion 
over 16 
year, 
Singeltone
, late 
PPROM 
(34-36.6) 
if PPROM  
was 
earlier 
pateints 
became 
eligible on 
reaching 
34 w. 
2000 
immediate 
birth in 
singleton 
pregnancies 
with PPROM 
close to term 
Vs Expectant 
management 
Multice
ntre 
RCT 
Lancet 
2016 
PPROMT 
 
Jonath
an M 
Morris, 
 

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(RR 0·6) intrapartum fever 
(0·4),  postpartum antibiotics 
(0·8), and longer hospital stay 
(p<0·0001), but a lower risk 
of CD (RR 1·4). 
median latency longer in  
(cefu), 4.63  Vs  (ampi), 2.3 
days (p = 0.039). CS- No 
difference. neonatal 
outcomes - no differences   
IAI rate  - No no difference 
Latency  (sample 
size was calculated 
to show 2 days 
difference) 
Placental 
abruption 
active labor, 
infection, and 
suspected fetal 
distress. 
Singletone 
, PPROM > 
24 w and 
<34 w lack 
of 
sensitivity 
to the 
study’s 
antibiotic 
regimen. 
87 
Rulid to all 
and 
Cefamezine 
Vs ampicellin 
RCT 
Internation
al Journal 
of 
Infectious 
Diseases 
2020 
A novel 
extended 
prophylactic 
antibiotic 
regimen in 
preterm pre-
labor rupture 
of 
membranes: 
A randomized 
trial 
Maya 
Wolf 
Neonatal sepsis occurred in 
1.1% at EMC and 0.5% at CI: 
0.11–27.14). composite 
secondary outcome occurred 
in nine (1.7%) and three 
(1.6%) neonates at EMC and 
HFH, respectively (adjusted p 
1⁄4 0.71; OR: 0.73; 95% CI: 
0.14–3.83). The gestational 
age at delivery was 36.1 and 
36.2 weeks at EMC and HFH, 
respectively (mean 
difference: 5 h; adjusted p 
1⁄4 0.02). The cesarean 
delivery rate was 24.7% and 
19.3% at EMC and HFH, 
respectively (adjusted p 1⁄4 
0.96). 
 
neonatal sepsis 
 
signs of 
chorioamnioniti
s or meconium 
staining at 
admission, or 
had fetal 
malformations 
diagnosed 
antenatally or 
immediately 
postpartum, 
were excluded.  
 
PPROM 
between 
340 and 
366weeks’ 
gestation 
with ROM  
 
660 
addition of 
latency 
antibiotics in 
late PPROM 
Vs 
Amoxicillin 
retrosp
ective 
two-
center 
study 
Am J 
Perinatol 
2024 
Perinatal 
Outcomes of 
Late Preterm 
Rupture of 
Membranes 
with or 
without 
Latency 
Antibiotics 
Mais 
Abu 
Nofal 
 
 
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the latency period in preterm premature rupture of membranes. J Matern Fetal Neonatal 
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2. Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol 
2003;101:178–193.  
3. Kenyon S, Boulvain M, Neilson J. Antibiotics for preterm rupture of membranes. 
Cochrane Database Syst Rev. 2003;(2):CD001058. doi: 10.1002/14651858.CD001058. 
Update in: Cochrane Database Syst Rev. 2010 Aug 04;(8):CD001058. doi: 
10.1002/14651858.CD001058.pub2. PMID: 12804398. 

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