The aim of this study is evaluation of effect of vaginal progesteron as maintenance tocolytic in prevention of preterm labor. Inclusion criteria: single tone pregnancy with 24-34 gestational age with premature delivery confirmed and intact fetal membranes. Exclution criteria: rupture of membranes, fetal anomaly and dysteress during the study and medical disease of peregnant women. Material and methods: 200 pregnant women with inclusion criteria admitted in the Kosar hospital with a diagnosis of preterm labor. Randomaly divided into two groups with 100 peoples. Control group treated with magnesium sulfate intravenously with initial dose of 4-6 gr and 2-4 gr per hours maintenance dose up to 24 hours and a corticosteroid, 2 doses of 12 mg betamethasone, with a 24 hours interval. In the treatment group in addition of the above-mentioned drugs, 200 mg of progesterone vaginally at the start of treatment and then adminstrated every 12 hours until disappearance of the uterine contractions. In the treatment group a 200 mg vaginal progesteron suppository daily given until the end of 34 weeks or delivery. Study outcomes is maternal-neonatal outcomes (the duration of time between start of treatment and stop contraction, latancy phase, apgar scores and birth weight, newborn complications until the end of 28 days, duration of admission in nicu, need to use ventilator and neonatal death that compared between control and treatment groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112331046N1
Registration date:2017-05-29, 1396/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Fahimeh Takallo
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3223 6374
Email address
f.takallo@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tocolysis vaginal progesterone ether as preservatives in preventing preterm delivery
Public title
The effect of progesterone in the prevention of preterm delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancies between 24-34 weeks gestational age; premature delivery confirmation by: regular uterine contractions (with a length of more the 30 second and more than 3 times per 10 minutes) with dilatation of the cervix 0-2 centimetres in nolipars and 0-3 centimetre in moltipars; intact fetal membranes.
exclusion criteria: rupture of the membranes during treatment; fetal anomaly; any evidence of fetal distress (chorioamnionitis, Preeclampsia, placental abruption, intrauterine growth restriction); sensitivity to progesterone (dizziness, headache, depression, high blood sugar during usage); history of medical illness in the mother (high blood pressure, cancer, epilepsy, chronic thromboambolic disease, liver disease); patients with asthma treated with oral beta-adrenergic.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
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
1
Registry name
NO
Secondary trial Id
NO
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Approval date
2015-11-04, 1394/08/13
Ethics committee reference number
IR.QUMS.REC.1394.200
Health conditions studied
1
Description of health condition studied
Preterm labour without delivery
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
Delay of delivery
Timepoint
post partum
Method of measurement
documented data
Secondary outcomes
1
Description
Neonatal distress
Timepoint
after delivery
Method of measurement
Documented data
2
Description
Birth weight
Timepoint
After delivery
Method of measurement
Documented data
3
Description
Apgar at birth
Timepoint
After delivery in 1 and 5 minutes
Method of measurement
Documented data
4
Description
Gestational age at birth
Timepoint
after delivery
Method of measurement
documented data
5
Description
Perinatal Mortality
Timepoint
after delivery
Method of measurement
documented data
6
Description
Fetal death
Timepoint
after delivery
Method of measurement
documented data
7
Description
NICU admission
Timepoint
after delivery
Method of measurement
documented data
Intervention groups
1
Description
Giving 200mg vaginal progesteronin in case group after confirmed preterm laber and treat with sulfat manuazum and corticosteroid.If the pain isnt offafterr 12 hour it is repeated then after of control pain it is giving daily until 34 weeks or delivery.
Category
Treatment - Drugs
2
Description
In control group after confirmed preterm laber none drug inadditon of sulfat manuaziom and corticosteroid is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr Fahimeh Takallo
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Bahonar Blvd , Qazvin , Iran
City
Qazvin
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 of Qazvin 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
Kowsar Hospital
Full name of responsible person
Dr Fahimeh Takallo
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3223 6374
Fax
Email
fahimeh_takallo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Fateme Lalooha
Position
Associat Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3223 6374
Fax
Email
lalooha44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Fahimeh Takallo
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
00
Fax
Email
fahimeh_takallo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)