The purpose of this study was to compare the effect of azithromycin and erythromycin on pregnancy outcome in mothers with PPROM.
Design
The clinical trial, with parallel groups, double-blind, randomized, phase 1-2 on 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Shahid Sadoughi Hospital of Yazd
Participants/Inclusion and exclusion criteria
This study will be conducted on women with a gestational age of more than 24 weeks, Women with a gestational age of less than 24 weeks, women with a cerclage, history of smoking, trauma or injury that led to PPROM, a congenital or fatal fetal anomaly, and those that consumed other antibiotics before referral, will be excluded from the study. This study will be conducted on 60 patients with PPROM after approval by the ethics committee.
Intervention groups
Group A will treat with oral azithromycin one gram single dose (n=30) and group B will treat with oral erythromycin 400 mg 4 times daily for 7 days (n=30).
Main outcome variables
Primary outcome includes latency period and chorioamnionitis.
Secondary outcome includes cesarean delivery, amniotic fluid stained with meconium, postpartum endometritis and neonatal sepsis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230129057268N1
Registration date:2023-02-11, 1401/11/22
Registration timing:registered_while_recruiting
Last update:2023-02-11, 1401/11/22
Update count:0
Registration date
2023-02-11, 1401/11/22
Registrant information
Name
Mohadese Besharati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3417
Email address
hasanemami1988@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of azithromycin and erythromycin effect in reducing complications of preterm premature rupture of membranes: a clinical trial study
Public title
Comparison of azithromycin and erythromycin effect in reducing complications of preterm premature rupture of membranes: a clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a gestational age of more than 24 weeks will be included in this study.
Exclusion criteria:
Women with a gestational age of less than 24 weeks, women with a cerclage, history of smoking, trauma or injury that led to PPROM , a congenital or fatal fetal anomaly, and those that consumed other antibiotics before referral, will be excluded from the study.
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
women randomly will be divided into two groups by considering 8 random blocks of size 8 and each person in each group will receive the desired treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pregnant women receiving erythromycin and azithromycin regimens will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Shahid Sadoughi University of Medical Sciences
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.047
Health conditions studied
1
Description of health condition studied
preterm premature rupture of membranes (PPROM)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Latency period
Timepoint
The interval between the rupture of the membranes and the onset of labor
Method of measurement
Length of latency was calculated in days by subtracting the time of delivery from the time of membrane rupture.
2
Description
Clinical chorioamnionitis
Timepoint
Before delivery
Method of measurement
Clinical chorioamnionitis will be determined by clinical symptoms including fever and tachycardia and ....
3
Description
Type of delivery
Timepoint
Delivery time
Method of measurement
Observation
4
Description
Amniotic fluid with meconium
Timepoint
Before delivery
Method of measurement
Amniotic fluid stained with meconium will be determined by clinical symptoms such as fetal distress, observation of meconium discharged from amniotic fluid.
5
Description
Postpartum endometritis
Timepoint
48 to 72 hours after delivery
Method of measurement
Postpartum endometritis will be determined by the mother's fever, mother's abdominal pain, mother's unpleasant odor secretions.
6
Description
Neonatal sepsis
Timepoint
72 hours after birth
Method of measurement
Neonatal sepsis will be determined by ذlood culture
7
Description
Neonatal mortality
Timepoint
After delivery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
This study is a randomized clinical trial. group A (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 1000 mg azithromycin orally as a single dose. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group B in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn .
Category
Treatment - Drugs
2
Description
Intervention group: group B (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 400mg erytromycin orally every 6 hour for 7 days. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group A in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Atiyeh Javaheri
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 3414
Fax
+98 35 3820 3414
Email
hasanemami1988@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
javaheri Atiyeh
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3414
Fax
+98 35 3820 3414
Email
hasanemami1988@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atiye Javaheri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
38203414
Email
atiyeh56@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atiye Javaheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Fax
+98 35 3820 3414
Email
atiyeh56@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atiye Javaheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3414
Email
atiyeh56@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available