Clinical trial comparing the effect of 300 milligram intramuscular progesterone with oral nifedipine on threatened preterm labor in pregnant women hospitalized with threatened preterm labor
We intended to compare the tocolytic effect of 300 milligram intramuscular progesterone with oral nifedipine on threatened preterm labor in pregnant women hospitalized in Akbarabadi Hospital with threatened preterm labor from 2011-1012. 497 cases entered the study. All women with single fetus pregnancy, aged 18-45, who referred with active uterine contractions and admitted for threatened preterm labor were enrolled to our study. Any patient with active phase of labor, or active infection, or any fetal problem will be excluded. The patients were then randomized according to a simple randomization (toss of a coin) and were divided into two groups: one group will receive 200 milligram intramuscular progestrone and the other group will receive oral nifedipine as tocolytic agents and will be followed until stopping uterine contractions. The researchers measuring the outcomes and the analyzer were blind about the type of intervention each patient was receiving. Then the tocolytic effect of drugs on treatment of threatened preterm labor will be compared. Outcomes, such as age at delivery, type of delivery, fetal birth weight will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112198469N1
Registration date:2015-12-08, 1394/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-08, 1394/09/17
Registrant information
Name
Zahra Najmi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 3561
Email address
zahranaj@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2011-12-20, 1390/09/29
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effect of 300 milligram intramuscular progesterone with oral nifedipine on threatened preterm labor in pregnant women hospitalized with threatened preterm labor
Public title
Is intramuscular progesterone as effective as oral nifedipine for treating threatened preterm labor?
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-45 years; women with single pregnancy; women with pregnancy between 26-34 weeks of gestational age; women who referred with active uterine contractions and admitted for threatened preterm labor.
Exclusion criteria:
women with active labor phase (Cervical dilatation>3cm; vaginal bleeding; rapture of membrane; over distension of the uterus (multifetal gestation or polihydramnios); any systemic infection; oral temperature>38; intrauterine growth retard (IUGR) fetus; fetal distress; blood pressure>140/90 mmHg; any contraindication for progestrone or nifedipine administration; history of any thromboembolic disorders.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2011-06-15, 1390/03/25
Ethics committee reference number
338
Health conditions studied
1
Description of health condition studied
Preterm Labor
ICD-10 code
o60
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
Stopping uterine contractions
Timepoint
Before intervention, each hour until contractions stop, 12 hours after stopping contractions
Method of measurement
Tocometry
Secondary outcomes
1
Description
Delivery time
Timepoint
Date of neonate's birth
Method of measurement
Gestational age at the time of delivery
2
Description
Reccurance of preterm contractions
Timepoint
every week
Method of measurement
tocometry
3
Description
Neonate status
Timepoint
Time of delivery, time of discharge
Method of measurement
Apgar score, hospitalization period, need for NICU
Intervention groups
1
Description
Intervention 1: Intra-mascular progestrone 200 mg (100 mg in each gluteus maximus)
Category
Treatment - Drugs
2
Description
Intervention 2: Oral nifedipine with standard dosage (started with a loading dose of 30 mg and continued with 10-20 mg every 4-6 hours until pain relief)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar-Abadi hospital
Full name of responsible person
Zahra Najmi
Street address
Shahid Akbar-Abadi Hospital, Molavi Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Javad Musavi
Street address
Research Deputy office of Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Zahra Najmi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, corner of Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
zahranaj@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Ladan Haghighi
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, corner of Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
dr.ladanhaghighi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Najmi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, corner of Ghods st., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
zahranaj@student.tus.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)