To compare the efficacy of two tocolytic agents; nifedipine and indomethacin; for inhibiting preterm uterine contractions as monotherapy and combination therapy.
Design
Randomized double blind clinical trial on 150 pregnant women with spontaneous preterm labor .
Settings and conduct
labor ward of a teaching hospital.Placebo was used for blinding the participants and investigator.
Participants/Inclusion and exclusion criteria
Participants: 150 pregnant women with gestational age of 26-34 weeks of pregnancy with diagnosis of preterm labor and without any conditions that contraindicated for treatment of preterm labor.
Intervention groups
Intervention groups:
Group A; 100 mg rectal indomethacin was administered along with an oral placebo.
Group B; 20 mg oral nifedipine was administered along with a rectal placebo.
Group C; a combination of rectal indomethacin and oral nifedipine was administered.
Main outcome variables
The primary outcome was delivery after 48 hours and deliveries before 34 weeks of gestation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091023002624N26
Registration date:2018-08-03, 1397/05/12
Registration timing:retrospective
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2018-03-25, 1397/01/05
Actual recruitment start date
2016-05-01, 1395/02/12
Actual recruitment end date
2018-03-25, 1397/01/05
Trial completion date
empty
Scientific title
A comparative study on the efficacy of nifedipine and indomethacin for prevention of preterm birth as monotherapy and combination therapy
Public title
Treatment of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age of 26 to 34 weeks
singleton
uterine contractions with a frequency of at least 4 forceful uterine contractions per 20 minutes or a cervical dilatation of minimum 1 cm and minimum 50% cervical effacement.
Exclusion criteria:
rupture of membrane
intrauterine fetal death
cervical dilatation of more than 5 cm
multiple pregnancy
receiving tocolytic within past 24 hours
polyhydramnios
preeclampsia and eclampsia
vaginal bleeding more than bloody show
any maternal and fetal condition that contradict with receiving tocolitics
severe fetal anomalies contradict fetal life
fetal distress
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization using sealed envelops.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants and the investigators did not know how the patients were allocated to the three groups. The groups were named as A, B and C and placebo were used to blind them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Inhibiting the contractions in the first 2 hours after intervention
Timepoint
2 hours after intervention
Method of measurement
Tocometer
2
Description
delivery within 7 days after intervention
Timepoint
7 days after intervention
Method of measurement
Birth date
3
Description
gestational age at the time of birth
Timepoint
time of birth
Method of measurement
birth date
4
Description
duration of prolongation of pregnancy
Timepoint
birth date
Method of measurement
Data sheets
Intervention groups
1
Description
Intervention group: group A; 100 mg rectal indomethacin was administered along with an oral placebo. If the patient responded to the initial treatment after two hours, 25 mg of oral indomethacin was administered every 4 hours plus placebo. The maximum daily dosage of indomethacin was 200 mg/day and the maximum duration of administration was 48 hours.
Category
Treatment - Drugs
2
Description
Intervention group: group B; 20 mg oral nifedipine was administered along with a rectal placebo. After 90 minutes, more 20 mg of oral nifedipine was administered. In case of responding to the initial treatment, 20 mg of oral nifedipine was continued every 3 hours for 72 hours at a maximum dose of 180 mg per day, with a placebo that was given every 4 hours (similar to the indomethacin protocol).
Category
Treatment - Drugs
3
Description
Intervention group: group C; a combination of rectal indomethacin and oral nifedipine was administered per protocol as mentioned above.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Malakouti
Street address
Hemmat Highway, Chamran Cross
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
Private
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Presenting at a paper, congress or seminars.
When the data will become available and for how long
After publication of the paper
To whom data/document is available
Iran University of Medical Sciences
Under which criteria data/document could be used
Permission from Iran University of Medical Sciences
From where data/document is obtainable
From Iran University of Medical Sciences
What processes are involved for a request to access data/document