Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes on Neonatal and Maternal outcomes , A clinical trial study
Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes on Neonatal and Maternal outcomes between 26-34 weeks
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 110 patients. Block method was used for randomization
Settings and conduct
A randomized clinical trial study was performed in Golestan province, Gorgan, Sayad Shirazi Hospital
Participants/Inclusion and exclusion criteria
Pregnant women 18-45years
Fetus age between 26-34weeks based on ultrasound of the first trimester of pregnancy
Diagnosis of PPROM based on observation of leakage during speculum examination, nitrazine positive test that these pregnant PPROM mothers are without labor pains.
Intervention groups
All pregnant women in the case and control groups received a seven-day course of antibiotics, including one gr oral azithromycin at the beginning of hospitalization and 2 grams of intravenous ampicillin every 6 hours for the first 48 hours of hospitalization, followed by oral amoxicillin. (500 mg every 8 hours) for 5 days after the end of 48 hours of intravenous ampicillin. In addition, pregnant women in the intervention group received 400 mg of progesterone suppository made by Abu Reihan Pharmaceutical Company once a day rectally.
Main outcome variables
Determining and comparing the latent phase; Infection; Birth weight and Apgar score and hospitalization in NICU in pregnant women with PPROM diagnosis at 26 to 34 weeks gestational age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200610047716N1
Registration date:2020-08-18, 1399/05/28
Registration timing:retrospective
Last update:2020-08-18, 1399/05/28
Update count:0
Registration date
2020-08-18, 1399/05/28
Registrant information
Name
Behnaz Gonabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 4261
Email address
dr.gonabadi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
2019-12-31, 1398/10/10
Actual recruitment end date
2020-06-21, 1399/04/01
Trial completion date
2020-06-21, 1399/04/01
Scientific title
Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes on Neonatal and Maternal outcomes , A clinical trial study
Public title
Effect of rectal Progesterone on Latent Phase Prolongation in Patients with Preterm Premature Rupture of Membranes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 18-45 years
Fetus age between 26-34 weeks based on first trimester of pregnancy ultrasound
PPROM diagnosis based on observation of leakage during speculum examination, nitrazine positive test that these pregnant mothers PPROM without labor pain
Exclusion criteria:
Fetus chromosomal abnormalities
Abnormal biophysical profiles less than 4
Intrauterine growth restriction and weight less than ten percent according to the Alexander Growth Standard
Maternal fever greater than 38 ° C
Bleeding after week 24
Chorioamnionitis based on maternal criteria
Type 1 diabetes
Preeclampsia includes high blood pressure and proteinuria after 20 weeks of pregnancy
Cervical discharge and severe obstetric medical diseases
Taking corticosteroids or systemic steroids
Receive antibiotics one week before hospital admission and antibiotic sensitivity
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks
A for intervention and B for placebo
B A B A 2) B B A A 1)
B A A B 4) A B B A 3)
A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-08-16, 1399/05/26
Ethics committee reference number
IR.GOUMS.REC
Health conditions studied
1
Description of health condition studied
PPROM
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increased latent phase of labor
Timepoint
From the beginning of the latent phase to the end of the latent phase
Method of measurement
Measurement of latent phase duration based on clinical examination
2
Description
neonatal Apgar score
Timepoint
Apgar score of the first and fifth minutes after birth
Method of measurement
Based on Apgar scoring criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipients of rectal progesterone suppository 400 mg ( Abu Reihan Company production), once a day
Category
Treatment - Drugs
2
Description
Control group: No therapeutic intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi Hospital
Full name of responsible person
Dr. Shohreh Vosough
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
shohre.007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
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
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Behnaz Gonabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
gonabadibehnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. behnaz Gonabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
gonabadibehnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Behnaz Gonabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
gonabadibehnaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data to complete the research process on the effects of rectal progesterone use in pregnant women with PPROM
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
What processes are involved for a request to access data/document
Contact the author of the article responsible for the research project data.Specify the type of results requested.