Evaluation of oral probiotics on prevention of preterm delivery in mothers at risk of preterm delivery compared with placebo
Design
clinical trial with control group; With Parallel groups; randomized; design of 120 patients
Settings and conduct
Eligible patients entering the study referred to Imam Sajjad Hospital of Yasuj University of Medical Sciences will be divided into two groups of 60 people and the consequences of preganncy will be measured.
Participants/Inclusion and exclusion criteria
Patient age 18-45 years, gestational age between 16-24 weeks, absence of syphilis, gonorrhea and HIV clinically, having risk factors for preterm delivery in the current pregnancy, including a history of preterm, delivery or a second trimester abortion in a previous pregnancy, no elective or emergency cerclage, lack of maternal insulin-dependent diabetes mellitus, treatment of hypertension, lupus, no clinical chorioamnionitis
Intervention groups
Group A : Lactofem capsule (500 mg) made by Iranian zist-takhmir Company will be administered orally and daily from the 16 weeks until the end of pregnancy. Group B : Placebo drug is very similar to group A with the same method, the duration of treatment will be prescribed. The placebo drug will be prepared by a zist-takhmir company similar to probiotics. In both groups, intramuscular injection of 250 mg of 17 alpha hydroxy progesterone caproate will be given intramuscularly from 16 weeks to 37 weeks of pregnancy.
Main outcome variables
Premature preterm birth (less than 34 weeks gestation), late preterm birth (34-37 weeks gestation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049300N1
Registration date:2021-10-02, 1400/07/10
Registration timing:registered_while_recruiting
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Mansooreh Sangchooli moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0165
Email address
parsatop007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-18, 1400/06/27
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral probiotics on the prevention of preterm delivery in mothers at risk of preterm delivery compared with placebo
Public title
Effect of oral probiotics on the prevention of preterm delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age 18-45 years
Gestational age between 16-24 weeks
Absence of syphilis, gonorrhea and HIV clinically
Having risk factors for preterm delivery in the current pregnancy, including a history of preterm delivery or a second trimester abortion in a previous pregnancy
No elective or emergency cerclage
Lack of maternal insulin-dependent diabetes mellitus, treatment of hypertension, lupus
Exclusion criteria:
Reluctance to participate in the study
Failure to complete the course of treatment or use of probiotics
Taking drugs that affect the intestinal microbial flora, such as antibiotics
Occurrence of any genital or urinary tract infection requires antibiotic treatment during treatment
Fetus with congenital malformations and abnormal scan anomalies
Clinical chorioamnionitis
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process is done with Random Allocation Soft ware. Randomization is done using the block method. It is an individual randomization unit. Randomization is performed using a table of random numbers and a computer is used to generate a random sequence online. To hide the treatment allocation, the list of treatments is placed in sealed and numbered envelopes (to maintain sequence order).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2020-09-23, 1399/07/02
Ethics committee reference number
IR.YUMS.REC.1399.132
Health conditions studied
1
Description of health condition studied
preterm delivery
ICD-10 code
O60.1
ICD-10 code description
Preterm labor with preterm delivery
Primary outcomes
1
Description
Premature preterm birth (less than 34 weeks gestation)
Timepoint
End of intervention
Method of measurement
Symptom
2
Description
Late preterm birth (34-37 weeks gestation)
Timepoint
End of intervention
Method of measurement
Symptom
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lactofem capsule (500 mg) made by Iranian zist-takhmir Company will be administered orally and daily from the 16 weeks until the end of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: Placebo drug is very similar to group A with the same method, the duration of treatment will be prescribed. The placebo drug will be prepared by a zist-takhmir company similar to probiotics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Raziyeh Vanda
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
parsatop007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Vanda
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
ra.vanda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Vanda
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
ra.vanda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Vanda
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
ra.vanda@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD