Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancy
Comparison of the effectiveness of azithromycin and erythromycin on the rate of clinical chorioamnionitis and the period of delay until the end of pregnancy in women with premature rupture of the amniotic sac.
Design
Phase 3 of a randomized clinical trial with parallel groups, triple-blind, will be conducted on 120 pregnant mothers with premature rupture of the amniotic sac, who have been randomly assigned to two intervention groups in a block of four. A table of random numbers will be used for randomization.
Settings and conduct
Pregnant women presenting at Ayatollah Mousavi Zanjan Hospital with a complaint of premature rupture of membranes will be allocated to two intervention groups using a random block of four. The study is designed as triple-blind, ensuring that the patient, outcome assessor, and data analyzer will be unaware of the treatment regimen. The initial intervention will involve administering a 1000 mg oral dose of azithromycin once. The second intervention group will be given 400 mg of oral erythromycin daily for 7 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gestational age between 26 and 34 weeks
singleton pregnancy
confirmed Premature rupture of the water sac
A live fetus
Exclusion criteria:
The presence of any other infection in the mother that requires antibiotic therapy
Congenital anomaly of the fetus
Delivery less than 24 hours after receiving antibiotics
Intervention groups
The first intervention group will be given 1000 mg of oral azithromycin as a single dose. The second intervention group will take 400 mg of oral erythromycin daily for 7 days. Both groups will also get 2 grams of intravenous ampicillin every 6 hours for 48 hours, followed by 500 mg of amoxicillin every 8 hours for one week
Main outcome variables
Chorioamnionitis, The time elapsed from the rupture of the amniotic sac to the exit of the fetus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240513061769N1
Registration date:2024-05-23, 1403/03/03
Registration timing:prospective
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Atena Alavi nasr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0981
Email address
alaviatena@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-25, 1403/03/05
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancy
Public title
Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 26 and 34 weeks
Singleton pregnancy
Confirmed Premature rupture of the water sac
A live fetus
Exclusion criteria:
The presence of any other infection in the mother that requires antibiotic therapy
Fetal congenital anomaly
Delivery within 24 hours after receiving antibiotics
Hypersensitivity to ampicillin, erythromycin, or azithromycin
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected using the available method and then assigned to two intervention groups using the random block method of four. For this purpose, blocks of four will be chosen using a random number table to ensure a sample size of 60 people in each group. Blocking will be conducted by an individual not part of the sampling process. The random sequences will be documented on cards, which will then be placed in envelopes sequentially. Subsequently, the envelopes will be sealed and put in a box. At the beginning of the intervention, one envelope will be opened to disclose the assigned group for that participant.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is designed as a triple-blind. Each participant will be assigned to two intervention groups using a random block method of four. Participants will be unaware of the treatment groups, which will be coded as Groups A and B. The research assistant will assess outcomes for each code without knowledge of the treatment type. During statistical analysis, the statistician will receive group information in code form and remain unaware of the treatment regimen.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Jomhori Eslami St, Azadi Square, The Ethics Committee, The Vice Chancellor for Research of Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2024-05-16, 1403/02/27
Ethics committee reference number
IR.ZUMS.REC.1403.035
Health conditions studied
1
Description of health condition studied
Premature Rupture of Amniotic Membranes
ICD-10 code
O42.91
ICD-10 code description
Preterm premature rupture of membranes, unspecified as to length of time between rupture and onset of labor
2
Description of health condition studied
Chorioamnionitis
ICD-10 code
O41.122
ICD-10 code description
Chorioamnionitis, second trimester
Primary outcomes
1
Description
Clinical chorioamnionitis
Timepoint
Before the start of the intervention, After the start of the intervention until the time the fetus is completely removed from the uterus
Method of measurement
Fever above 38 degrees Celsius, Fetal Tachycardia, Maternal Tachycardia above 100 beats per minute, Increased WBC Count in the mother's serum to more than 15000 c/mm, or Discharge of purulent fluid from the vagina.
Secondary outcomes
1
Description
The period of delay until the childbirth
Timepoint
Every hour until the time of delivery of the fetus
Method of measurement
The elapsed time from the rupture of the water sac to the childbirth of the fetus in hours
Intervention groups
1
Description
Intervention group: They will be given 1000 mg of oral azithromycin (Two 500 mg tablets) as a single dose and 2 gr of intravenous ampicillin every 6 hours for 48 hours, followed by 500 mg of Capsules amoxicillin every 8 hours for one week.
Category
Treatment - Drugs
2
Description
Intervention group: They will be given 400 mg of oral tablet erythromycin daily for 7 days and 2 gr of intravenous ampicillin every 6 to 48 hours, then switch to taking 500 mg amoxicillin capsules every 8 hours for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Moussavi Hospital
Full name of responsible person
Atena Alavi
Street address
Gavazang Road, Ayat Mousavi Specialized and Sub-specialized Medical Training Center, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Phone
+98 24 3313 0001
Fax
+98 912 436 7151
Email
alaviatena@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hossein Mustafavi
Street address
Jomohri St., Azadi Blvd., Research Deputy of Zanjan University of Medical Sciences, Zanjan, Iran