This is a randomized double blind clinical trial in preventing preterm labor. Inclusion criteria were: 26-36 weeks of gestation, intact membrane and confirmed preterm labor. Exclusion criteria were: disruption of treatment, lack of sufficient data and occurrence of preeclampsia. During the study course, subjects were in their 26-36 weeks of gestation with a diagnosis of preterm labor referring to Al-Zahra maternity hospital. Two hundred and sixty women were randomly assigned into the two groups. All underwent routine management of preterm labor and signed a formal consent. Subjects received either progesterone or placebo. Once a parturient was labeled as preterm, she was given a vaginal suppository. After two hours the subject was examined for cessation of labor pain. If no contraction was detected, the woman was sent to a prelabor control ward, with hydration and relative Bed Rest order. She was given a vaginal supp. per day and was discharged after 24 hours from discontinuation of contractions. They were warned against excessive physical activity and advised for prompt referral in case of labor pain. Vaginal supp should be continued till 36 weeks gestation. The aim of the study was to compare the rate of days in delay of delivery and so, maternal and neonatal complication in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706051096N1
Registration date:2009-02-20, 1387/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-02-20, 1387/12/02
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research-Guilan Universityof Medical Sciences
Expected recruitment start date
2009-01-22, 1387/11/03
Expected recruitment end date
2010-01-23, 1388/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vaginal Progesterone in preventing preterm labor
Public title
Evaluation of the effect of vaginal Progesterone in preventing preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women were eligible to enter the trial if 1) they were between 26-36 weeks of gestation based on their LMP or sonography before 16 weeks of gestation. 2) Confirmation of premature delivery with a)uterine contractions more than 30 seconds and three or more contractions per 30 minutes established by tochodynamometer b) cervical dilatation of 0-2 cm in nulliparous and 1 -2 cm in multiparous and cervical effacement greater than 50% 3) intact membrane.
Exclusion criteria included: 1) unwillingness or inability to comply with study procedures before 36 weeks of gestation 2) lack of useful sufficient data 3) preeclampsia requiring termination of pregnancy.
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research-Guilan University of Medical Sciences
Street address
Vice chancellor for research-Guilan University of Medical Sciences-opposite of Azodi Studium-Namjo street
City
Rasht
Postal code
Approval date
empty
Ethics committee reference number
6219
Health conditions studied
1
Description of health condition studied
prevention of preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labour
Primary outcomes
1
Description
prevention of preterm labour( before 37 weeks)
Timepoint
2 hours after insertion of suppository, then weekly visit
Method of measurement
control of uterine contraction
2
Description
Prevention of preterm labor (before 34 weeks)
Timepoint
every two weeks
Method of measurement
Patient visits, uterine contraction determination
Secondary outcomes
1
Description
Delay of delivery
Timepoint
post partum
Method of measurement
documented data
2
Description
Duration of hospitalization
Timepoint
post partum (weekly)
Method of measurement
documented data
3
Description
Mean of frequancy,intensity and duration of contractions
Timepoint
48 hours after initiation of therapy
Method of measurement
detected by Tochodynamometer
4
Description
Delay of delivery
Timepoint
postpartum
Method of measurement
documented data
5
Description
Delay for a week of delivery
Timepoint
after delivery
Method of measurement
documented data
6
Description
Low birth weight
Timepoint
after delivery
Method of measurement
documented data
7
Description
APGAR score below 7
Timepoint
after delivery
Method of measurement
documented data
8
Description
NICU admission
Timepoint
after delivery
Method of measurement
documented data
9
Description
Perinatal Mortality
Timepoint
after delivery
Method of measurement
documented data
10
Description
Fetal death
Timepoint
after delivery
Method of measurement
documented data
11
Description
Neonatal distress
Timepoint
after delivery
Method of measurement
documented data
12
Description
Postpartum Retinopathy
Timepoint
after delivery
Method of measurement
documented data
13
Description
Necrotizing entrocolitis
Timepoint
after delivery
Method of measurement
documented data
14
Description
Neonatal sepsis
Timepoint
after delivery
Method of measurement
documented data
15
Description
Intraventicular hemorrhage
Timepoint
after delivery
Method of measurement
documented data
16
Description
side effects of progesteron
Timepoint
every two weeks
Method of measurement
interview
17
Description
premature rupture of membranes
Timepoint
during delivery
Method of measurement
documented data
18
Description
chorioamnionitis
Timepoint
after delivery
Method of measurement
documented data
19
Description
Severe hemorrhage (blood transfusion)
Timepoint
after delivery
Method of measurement
documented data
20
Description
Days of hospitalization
Timepoint
after delivery
Method of measurement
documented data
Intervention groups
1
Description
Intervention group: Progesterone vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day.
Category
empty
2
Description
Control group: Placebo vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day.
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital,Rasht
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research-Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Seyede Hajar Sharami
Position
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Sharami@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Giulan University of Medical Sciences
Full name of responsible person
Dr.Seyede Hajar Sharami
Position
Associated professor-Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Sharami@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproduction Health Reseach Center
Full name of responsible person
Seyede Fatemeh Dalil Hirati
Position
Bs in Midwifery
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
H_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)