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Protocol summary
In this clinical trial with phase 2-3, with two intervention groups and without any control group, patients divides randomly into two groups of 73. The study will be done as single blind study.
In this clinical trial with phase 2-3, with two intervention groups and without any control group, 146 patients divides randomly into two groups of 73. The study will be done as single blind study.
In this clinical trial with phase 2-3, with two intervention groups and without any control group, 146 patients divides randomly into two groups of 73. The study will be done as single blind study.
در این کارازمایی بالینی با فاز 2-3، دارای دو گروه مداخله و بدون گروه کنترل، بیماران به صورت تصادفی و استفاده از جدول اعداد تصادفی به دو گروه 73 نفری تقسیم میشوند. این مطالعه به صورت یک سو کور انجام می شود.
در این کارازمایی بالینی با فاز 2-3، دارای دو گروه مداخله و بدون گروه کنترل، 146 بیمار به صورت تصادفی و استفاده از جدول اعداد تصادفی به دو گروه 73 نفری تقسیم میشوند. این مطالعه به صورت یک سو کور انجام می شود.
در این کارازمایی بالینی با فاز 2-3، دارای دو گروه مداخله و بدون گروه کنترل، بیماران146 بیمار به صورت تصادفی و استفاده از جدول اعداد تصادفی به دو گروه 73 نفری تقسیم میشوند. این مطالعه به صورت یک سو کور انجام می شود.
General information
Single-tone pregnancy
alive fetus
intact membrane
gestational age between 24-36 weeks
preterm labor
lack of cerclage
labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes
cervical dilatation equal to or greater than 1 cm
Single-tone pregnancy
alive fetus
intact membrane
gestational age between 24-36 weeks
preterm labor
lack of cerclage
labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes
cervical dilatation equal to or greater than 1 cm
ultrasound of the first 3 months of pregnancy
Single-tone pregnancy alive fetus intact membrane gestational age between 24-36 weeks preterm labor lack of cerclage labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes cervical dilatation equal to or greater than 1 cm ultrasound of the first 3 months of pregnancy
حاملگی تک قلویی
جنین زنده
کیسه آب سالم
سن حاملگی بین 36-24 هفته
زایمان زودرس
عدم سرکلاژ
درد زایمان به صورت انقباضات متناوب 2 بار در 10 دقیقه یا 8 بار در 60 دقیقه
اتساع دهانه رحم برابر یا بیشتر از 1 سانتی متر
حاملگی تک قلویی
جنین زنده
کیسه آب سالم
سن حاملگی بین 36-24 هفته
زایمان زودرس
عدم سرکلاژ
درد زایمان به صورت انقباضات متناوب 2 بار در 10 دقیقه یا 8 بار در 60 دقیقه
اتساع دهانه رحم برابر یا بیشتر از 1 سانتی متر
سونوگرافی 3 ماهه اول بارداری
حاملگی تک قلویی جنین زنده کیسه آب سالم سن حاملگی بین 36-24 هفته زایمان زودرس عدم سرکلاژ درد زایمان به صورت انقباضات متناوب 2 بار در 10 دقیقه یا 8 بار در 60 دقیقه اتساع دهانه رحم برابر یا بیشتر از 1 سانتی متر سونوگرافی 3 ماهه اول بارداری
Sharing plan
فرد مسول عمومی و یا علمی
فرد مسئول عمومی و یا علمی
فرد مسولمسئول عمومی و یا علمی
ارسال پروپوزال به ایمیل فرد مسول
ارسال پروپوزال به ایمیل فرد مسئول
ارسال پروپوزال به ایمیل فرد مسولمسئول
Protocol summary
Study aim
Comparison of oral and intramuscular progesterone in preterm labor
Design
In this clinical trial with phase 2-3, with two intervention groups and without any control group, 146 patients divides randomly into two groups of 73. The study will be done as single blind study.
Settings and conduct
Weekly, all the patients of two groups are followed up in the gynecology clinic of Afzalipour hospital. After delivery, delivery condition and time, delivery method, newborn weight, APGAR score and the need for NICU hospitalization are investigated. The complications followed by each of oral and injectable medications are registered. Regarding the study being single blinded, patients, physicians and midwives are aware of the treatment type and just the data analyzer is blind to the medication type.
Participants/Inclusion and exclusion criteria
Inclusion: preterm labor, single pregnancy, live fetus, healthy amniotic sac, gestation age (24-36 weeks), lack of cerclage, labor pains, cervical dilatation ≥1 cm.
Exclusion: PPROM, vaginal bleeding, cervical dilation >3 cm, fetal death or distress, maternal systemic diseases, known uterine anomalies, history of taking any medication other than the usual supplements, polyhydramnios and oligohydramnios, fetal anomaly, suspicion of intrauterine infection, being dangerous for the mother to continue the pregnancy, lack of cooperation of mothers.
Intervention groups
In the intervention group one, patient received a 200 mg capsule of luteogel daily containing micronized progesterone by Tesnim company, and in the second intervention group, patients received a weekly proletone 250 mg ampoule product of Bayer company treatment continued until delivery or 36 weeks. Patients are visited weekly.
Main outcome variables
Birth weight, gestational age at delivery, frequency of preterm labor in each group, duration of latency and frequency of admitted infants in each group
General information
Reason for update
The number of inclusion and exclusion criteria increased at the time of the study and the sample size in each group decreased at the time of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20190623043981N1
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2021-12-15, 1400/09/24
Update count:3
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Moeeneh Barkhori mehni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3252 1679
Email address
moeeneh1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-23, 1397/12/04
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy outcome following oral and intramuscular progesterone use in preterm labor
Public title
Comparison of oral and intramuscular progesterone in preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-tone pregnancy
alive fetus
intact membrane
gestational age between 24-36 weeks
preterm labor
lack of cerclage
labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes
cervical dilatation equal to or greater than 1 cm
ultrasound of the first 3 months of pregnancy
Exclusion criteria:
vaginal bleeding
known uterine anomalies
fetal anomalies
suspicion of intrauterine infection
preterm premature rupture of membranes (PPROM)
cervical dilation greater than 3 cm
fetal death or fetal distress
maternal systemic diseases
history of taking any medication other than the usual supplements during pregnancy
polyhydramnios and oligohydramnios
being dangerous for the mother to continue the pregnancy due to medical reasons
lack of cooperation of mothers during study
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
during this study, the data evaluator was unaware of the treatment types, while physician and patient blinding was impossible as the difference of the used methods was obvious to the them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-02-22, 1397/12/03
Ethics committee reference number
IR.KMU.AH.REC.1397.155
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
Birth weight
Timepoint
after delivery
Method of measurement
Scale
2
Description
gestational age at delivery
Timepoint
after delivery
Method of measurement
patient documents
3
Description
latency period
Timepoint
from beginning of intervention until delivery
Method of measurement
patient documents
4
Description
number of hospitalized neonates in each group
Timepoint
after delivery
Method of measurement
patient documents
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group one, until 36 weeks of pregnancy, 200 mg capsule containing micronized progesterone called luteogel produced by Tasnim company will be given daily .
Category
Treatment - Drugs
2
Description
Intervention group two a 250 mg progesterone ampoule containing hydroxy caproate produced of Byer company will be given weekly and treatment will continue until 36 weeks of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipor hospital
Full name of responsible person
Moeeneh Barkhori Mehni
Street address
Imam Khomeini Highway (RA), next to Shahid Bahonar University, Afzalipour Medical Education Center
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
moeeneh1367@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
Abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Moeeneh Barkhori Mehni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 8 Shyda Building Khajo 34 Street
City
Kerman
Province
Kerman
Postal code
7617778555
Phone
+98 34 3252 1679
Email
moeeneh1367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Moeeneh Barkhori Mehni
Position
Resident Gyn And Obs
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour Hospital Emam Highway
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 8307
Email
moeeneh1367@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Moeeneh Barkhori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
unit 8 Shyda building Khajo 34 street
City
Kerman
Province
Kerman
Postal code
7617778555
Phone
+98 34 3252 1679
Email
moeeneh136@gmail.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
Starting six months after the publication of the article
To whom data/document is available
Researchers, students and doctors
Under which criteria data/document could be used
To perform clinical examination
From where data/document is obtainable
General or scientific responsible person
What processes are involved for a request to access data/document