Investigation of maternal and neonatal outcomes of expectant treatment in pregnant women with preterm premature rupture of membranes (PPROM) in hospital compared with expectant treatment at home
Investigation of maternal and neonatal outcomes of expectant treatment in pregnant women with PPROM in hospital compared with expectant treatment at home
Design
Expectant treatment for both groups is as follows: in the first 72 hours of hospitalization, 2 grams of intravenous ampicillin in every 6 hours, 500 milligram amoxicillin capsule in every 8 hours and 400 milligram erythromycin tablet in every 6 hours are prescribed for a week. Two doses of 12 milligram Betamethasone are prescribed for intramuscular injection with a 24-hour interval in between. Accurate monitoring of the mother's vital signs, an assessment of the fetus health with daily NST and sonoghraphy and CBC twice a week are carried out. The mothers under surveillance at home monitor and record their daily fever and pulse rate and Patients are recommend to carry out NST simultaneously with CBC twice a week.
Settings and conduct
Assigning individuals to groups depends on their personal preferences for staying at home or hospital based on which the study is divided into two groups. Outpatients are those who knowingly and willingly discharge themselves and will be placed under surveillance at home.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Gestational age between 25 and 34 weeks, Evaluation for 72 hours in hospital, Having a caretaker at home, taking 60 minutes at most to reach the first treatment center. Exclusion criteria: Occurrence of chorioamnionitis, fetal tests of health evaluation, Vaginal bleeding
Intervention groups
Control group: After receiving expectant treatment, patients are hospitalized until delivery.
Intervention group: After receiving the expectant treatment, patients will be at home until delivery.
Main outcome variables
Duration of expectant treatment, gestational age at time of delivery, birth weight, number of cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181115041666N1
Registration date:2018-12-26, 1397/10/05
Registration timing:prospective
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Samaneh Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2806
Email address
akbarzadehs941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-25, 1398/02/05
Expected recruitment end date
2019-04-25, 1398/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of maternal and neonatal outcomes of expectant treatment in pregnant women with preterm premature rupture of membranes (PPROM) in hospital compared with expectant treatment at home
Public title
Comparison of expectant treatment outcomes in pregnant women with preterm premature rupture of membranes (PPROM) at home and hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
alive singleton pregnancy
Gestational age between 25 and 34 weeks
The absence of chorioamnionitis symptoms
The lack of evidence for fetal distress
No vaginal bleeding
Patient's consent
Evaluation for 72 hours in hospital
Cephalic presentation
Having a caretaker at home
Taking 60 minutes at most to reach the first treatment center
The diameter of maximum vertical pocket of the amniotic fluid is more than 2 Cm²
Exclusion criteria:
Occurrence of chorioamnionitis
disturbed fetal tests of health evaluation
Vaginal bleeding
Patient's unwillingness to continue participation in the study
Gestational age of less than 25 weeks of labor (greater than 3 cm of dilatation)
Age
No age limit
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MUMS.fm.REC.1396.640
Health conditions studied
1
Description of health condition studied
preterm premature rupture of membranes
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
Duration of expectant treatment course
Timepoint
From hospitalization to delivery
Method of measurement
duration in days
2
Description
gestational age at the time of delivery
Timepoint
at the time of birth
Method of measurement
Course duration is measured based on the number of weeks.
3
Description
Birth weight
Timepoint
at the time of child birth
Method of measurement
using scales
4
Description
number of cesarean section
Timepoint
Time of birth
Method of measurement
number of cesarean section in each group
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Expected treatment is that in the first 72 hours of hospitalization, 2 milligrams of intravenous ampicillin in every 6 hours, 500 milligram amoxicillin capsule in every 8 hours and 400 milligram erythromycin tablet in every 6 hours are prescribed for a week. Two doses of 12 milligram Betamethasone are prescribed for intramuscular injection with a 24-hour interval in between, and accurate monitoring of the mother's vital signs, an assessment of the fetus health with daily NST and ultrasound twice a week and CBC twice a week are carried out.
Category
Treatment - Drugs
2
Description
Intervention group: After 72 hours of hospitalization and receiving the expectant treatment, mothers go home with their consent and monitor and record their daily fever and pulse rate (twice a day) and in the event of any disorder, they will immediately refer to the hospital. The executor of the plan will provide the patients under surveillance with his/her phone number and monitor their vital signs through making phone calls or sending messages in Telegram. Patients are recommend to carry out NST simultaneously with CBC twice a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommol-Banin hospital
Full name of responsible person
Masoumeh Mirteimouri
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Samaneh Akbarzadeh
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
akbarzadehs941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
960209
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Akbarzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Akbarzadehs941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Akbarzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Akbarzadehs941@mums.ac.ir
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.