Comparison of vaginal and oral probiotics in the prevention of preterm labor
Design
This study was designed as a single-blinded randomized clinical trial with parallel groups and a sample size of 58 people in each group.
Settings and conduct
The study will be conducted at Kamali Hospital on pregnant women. Patients who signed informed consent will be randomly divided into three groups. The first group will receive probiotic tablets, daily from 25 weeks of pregnancy until 37 weeks of gestation. The second group will receive a probiotic vaginal capsule, daily from 25 weeks of pregnancy until 37 weeks of gestation, and the third group Will not receive any intervention. The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process
Participants/Inclusion and exclusion criteria
Inclusion criteria: Intact amniotic membrane No taking probiotics No maternal disease including pyelonephritis, preeclampsia, chronic hypertension, diabetes. Gestational age greater than or equal to 25 weeks Normal cervical length exclusion criteria: The mother's unwillingness to be in this study Cervical length less than 3 cm Existence of labor show Effective labor pains Oligohydramnios polyhydramnios placental abruption placenta previa hepatic impairment Existence of abnormal fetal heart rate pattern in monitoring Intrauterine infection
Intervention groups
Intervention group1: Oral probiotic pills once a day for up to 37 weeks of pregnancy
Intervention group2: Probiotic vaginal capsule once a day for up to 37 weeks of pregnancy
Control group: No intervention
Main outcome variables
preterm labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201024049128N2
Registration date:2020-12-19, 1399/09/29
Registration timing:prospective
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Bita Badehnoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
badehnoosh@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaginal and oral probiotics in the prevention of preterm labor
Public title
Comparison of probiotics in the prevention of preterm labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Intact amniotic membrane
No taking probiotics
No maternal disease including pyelonephritis, preeclampsia, chronic hypertension, diabetes.
Gestational age greater than or equal to 25 weeks
Normal cervical length
Exclusion criteria:
The mother's unwillingness to be in this study
Cervical length less than 3 cm
Existence of labor show
Effective labor pains
Oligohydramnios
polyhydramnios
placental abruption
placenta previa
hepatic impairment
Existence of abnormal fetal heart rate pattern in monitoring
Intrauterine infection
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
185
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization list will be prepared by the statistician (using the site: www. scale develope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained
Blinding (investigator's opinion)
Single blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants will aware of the type of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.ABZUMS.REC.1399.222
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
Delivery before 37 weeks
Method of measurement
Medical record
Secondary outcomes
1
Description
Kind of delivery
Timepoint
After labor
Method of measurement
Medical record
2
Description
NICU administration
Timepoint
After birth
Method of measurement
Medical record
Intervention groups
1
Description
Intervention group: Oral probiotic pills once a day for up to 37 weeks of pregnancy
Category
Prevention
2
Description
Intervention group: Probiotic vaginal capsule once a day for up to 37 weeks of pregnancy
Category
Prevention
3
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Bita Badehnoosh
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Bita badehnoosh
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bita badehnoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street