The aim of this study is the effect of progesterone in patients with premature rupture of membranes (PROM) and prolongs the incubation period at Al-Zahra hospital. Patients were randomly divided in two cases and controls groups (Each group consisted of 60 patients and in three age groups of 26-28 weeks/ 28-30 weeks/ 30-32 weeks and in each and in each age group studied 20 patients). Gestational age of pregnant women between 26 to 32 weeks with PROM diagnosis by having informed consent will be included in the study. In the cases of fetal abnormalities that can affect fetal growth, preeclampsia and being in the active phase of labor patients will be excluded. The first group received progesterone (400 mg intra-vaginal progesterone) and the second group did not receive progesterone. Treatment will continue to 34 weeks or to delivery. At baseline, patients were admitted in the maternity unit for 12 to 24 hours. All patients (cases and controls) will treated with Antibiotics and Betamethasone and the case group each night will receive rectal suppository progesterone and at least once a day twice a week will treated with BPP and NST respectively and chorioamnionitis will daily examined.
All patients have been hospitalized until delivery or up to the 34th week of pregnancy and lung maturation is checked and do not be treated with Tocolysis. In all patients PROM duration and onset of labor or termination planned at 34 weeks of pregnancy, puerperal fever, incidence of chorioamnionitis, birth weight, apgar 1 and 5, number of days of ventilated baby and neonatal deaths are recorded. Patients after discharge from the hospital twice a week for 6 weeks will be followed up by phone in terms of symptoms: Fever, chills, and foul-smelling purulent discharge from the vagina, abdominal pain and tenderness, shortness of breath and in case of abnormal symptoms patients will be seen in person at Al-Zahra Hospital.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512077676N4
Registration date:2016-04-06, 1395/01/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-06, 1395/01/18
Registrant information
Name
Simin Taghavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
taghavisi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2017-02-08, 1395/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progesterone in patients with premature rupture of membranes
Public title
The effect of progesterone in patients with premature rupture of membranes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with gestational age between 26 to 32 weeks with premature rupture of membranes (PROM); signing informed consent.
Exclusion criteria: fetal abnormalities; genetic abnormalities that can affect fetal growth that have been checked by ultrasound at 18 to 20 weeks and 28 to 32 weeks. Along with trisomy screening marker with double or quad marker; precambrian patients; chronic high blood pressure; overt diabetes; pregnancy-related diabetes; detachment; prolapsed umbilical cord; chorioamnionitis; gestational age over 32 weeks (because there isn’t sufficient time to study the effects of progesterone); patient who have had a rupture of the membranes after 36 hours; patient who are in active phase.
Age
From 15 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
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 Tabriz University of Medical Sciences
Street address
Ethics Committee Of Tabriz University Of Medical Sciences; Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-02-04, 1394/11/15
Ethics committee reference number
TBZMED.REC.1394.1008
Health conditions studied
1
Description of health condition studied
Premature rupture of membranes, labour delayed by therapy
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes, labour delayed by therapy
Primary outcomes
1
Description
Lengthening the interval between the pre-term delivery runny
Timepoint
Daily
Method of measurement
Physical examination
Secondary outcomes
1
Description
Improving Perinatal Outcomes
Timepoint
Follow baby daily until discharge
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group : progesterone ( 400 mg a daily intravaginal
Category
Treatment - Drugs
2
Description
Control group: routine treatment includes injections of betamethasone 12 mg of progesterone administered every 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Simin Taghavi
Street address
South Alzahra Hospital ; Artesh Street; Bagh shomal Crossroads
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Golgasht Street; Central Building Number Two; third floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Professor of obstetrics and gynecology specialist
Other areas of specialty/work
Street address
Tabriz University of medical Sciences; Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Professor Of Obstetricians and Gynecologists
Other areas of specialty/work
Street address
Golgasht Street; Tabriz University of medical sciences
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Professor Obstetricians and Gynecologists
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 41 3553 9161
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)