Comparison effect of oral Dydrogesterone on the treatment of preterm labor with oral Nifedipine in pregnant women admitted with a diagnosis of risk of preterm labor
Determining and comparing the effect of oral dydrogesterone on the treatment of preterm delivery with oral nifedipine in pregnant women admitted with diagnosis at risk of preterm delivery
Design
A clinical trial study of 60 women aged 18-45 years with a singleton pregnancy of 26-34 weeks hospitalized with a diagnosis of preterm delivery who were admitted to the study at the first visit and with a diagnosis of preterm delivery by double-blind random sampling.
Settings and conduct
For research, we need basic information such as age, gestational age, BMI, Threatened Preterm Labor, Preterm Labor, Preterm Delivery, PTL history, nifedipine use and Dydrogestrerone use. It is performed in Shahid Akbar Abadi and Hazrat Rasoul hospitals.
Participants/Inclusion and exclusion criteria
A total of 60 women aged 18-45 years with a singleton pregnancy of 26-34 weeks, admitted with a diagnosis of preterm labor, are included in the study.
Exclusion criteria include any maternal or fetal conditions that require immediate delivery (including fetal distress; placenta abruption; chorioamnionitis; severe preeclampsia; Patients who have entered the active phase of labor ( cervical dilatation>=4cm); vaginal bleeding; Ruptured of membrane; Uterine distention for example due to multiple pregnancy and polyhydramnios; The presence of any systemic infection; Fever greater than 38 degrees Centigrade; Intrauterine growth restriction; Blood pressure above 140/90 mm Hg; Fetal anomalies; Contraindications to the use of tocolytics, allergy to progesterone and a history of any thromboembolic disease.
Intervention groups
This interventional study is a randomized clinical trial that is performed on 60 single pregnant women with a gestational age of 26-34 weeks .
Main outcome variables
Study variables include dydrogesterone, preterm delivery, gestational age, neonatal complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038892N1
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Neda Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 9024
Email address
nedahashemi1363@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of oral Dydrogesterone on the treatment of preterm labor with oral Nifedipine in pregnant women admitted with a diagnosis of risk of preterm labor
Public title
effect of oral Dydrogesterone on the treatment of preterm labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A total of 60 women aged 18-45 years with a singleton pregnancy of 26-34 weeks, admitted with a diagnosis of preterm labor, are included in the study.
Exclusion criteria:
Exclusion criteria include any maternal or fetal conditions that require immediate delivery (including fetal distress; placenta abruption; chorioamnionitis; severe preeclampsia; Patients who have entered the active phase of labor ( cervical dilatation>=4cm); vaginal bleeding; Ruptured of membrane; Uterine distention for example due to multiple pregnancy and polyhydramnios; The presence of any systemic infection; Fever greater than 38 degrees Centigrade; Intrauterine growth restriction; Blood pressure above 140/90 mm Hg; Fetal anomalies; Contraindications to the use of tocolytics, history of any allergy to progesterone and a history of any thromboembolic disease.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly receive the first dose of 40 mg oral dydrogesterone and the second group oral standard nifedipine at the standard dose for tocolytic, and the results obtained from mothers and infants are compared in the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients after hospitalization in the maternity ward are randomly divided into one of the following two groups. The first group received 40 mg of oral dydrogesterone and after 8 hours, uterine contractions were monitored again by a tocometer. if Uterine contractions do not stop , continue a dose of 10 mg every 8 hours for 48 hours. If uterine contractions do not decrease after 8 hours with this drug, patients will be treated with nifedipine. And the second group will receive oral nifedipine at a standard dose according to the protocol (starting with a dose of 10 mg every 20 minutes to an hour and continuing with 20 mg every 6 hours to 24 hours and then 20 mg every 8 hours to the next 24 hours)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of medicine- Iran university of medical science
Street address
Hemmat Highway-IRAN university of medical science
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-01-08, 1395/10/19
Ethics committee reference number
IR.IUMS.REC.1395.9211290013
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
preterm labor
Timepoint
It is checked at the beginning of the study and then 8 hours later.
Method of measurement
vaginal examination and cervical asessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive 40 mg of oral dydrogesterone and after 8 hours, uterine contractions are monitored again by a tocometer. If uterine contractions are reduced, the same drug is continued at a dose of 10 mg every 8 hours for 48 hours. If uterine contractions do not decrease after 8 hours with this drug, patients will be treated with nifedipine.
Category
Prevention
2
Description
Control group: Oral nifedipine is administered at a standard dose according to the protocol (starting with 10 mg every 20 minutes to one hour and continuing with 20 mg every 6 hours to 24 hours and then 20 mg every 8 hours for the next 24 hours).
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Drugs dosage, sampling method and study results are shared.
When the data will become available and for how long
Is given at the end of the research.
To whom data/document is available
People working in university centers.
Under which criteria data/document could be used
For scientific promotion of university centers
From where data/document is obtainable
See the email below.
nedahashemi1363@yahoo.com
What processes are involved for a request to access data/document
First, the investigation should be completed and the applicant should send an e-mail stating all the details of his specifications, and his application will be reviewed, and if the information is approved, it will be sent to him. The time will be determined after the end of the research