Second trimester labor induction is a major problem in obstetrics.To compare the effectiveness of vaginal misoprostol and intravenous oxytocin in induction of labor,100 women 12-24 weeks of gestation will participate in a randomised controlled way. The inclusion criteria consis of mothers with Intra uterine fetal death; fetal anomaly; Premature rupture of membrane; maternal complications and parity below 6. Mothers with multigestations; chorioamnionits; prostaglandin contraindication and sufficient uterine contraction will be excluded from the study. one of two groups will get 200 micro gram vaginal tablet misoprostol and repeat after 12 hours if necessary. Another group of patients will receive 50 units of oxytocin in 500 ml of dextrose- saline infusion over 3 hours, one hour of no oxytocin, followed by a 100 unit in 500 ml solution over 3 hours, another of rest , and a 150 units in 500 ml over 3 hours , the oxytocin will increased to a final concentration of 300 units in 500 ml. In either treatment arm the assigned medication will be continued until either maximum dose will administer or delivery will occurr, whichever come first. The two groups will compare for induction to delivery intervals and their safety during inductions. The success rate In misoprostol group and in second group (after 24 hours) will be assessed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307159568N5
Registration date:2013-09-20, 1392/06/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University Medical of Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of vaginal misoprostol and intravenous oxytocin for induction of labor in women with second trimester pregnancy
Public title
Comparison of 2 different methods in Second trimester labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Intra uterine fetal death; fetal anomaly; PROM; maternal indications; Parity<5; previous cesarean section,
Exclusion criteria: multi pregnancy; prostaglandin contraindication; uterine contraction; mothers dissatisfaction; more than 2 cesarean sections; chorioamnionits; placenta previa
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bandar Abas University of Medical Sciences
Street address
Bandar Aabas, Medical University
City
Bandar Abas
Postal code
Approval date
2004-09-22, 1383/07/01
Ethics committee reference number
83/84/32
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
O00-O08
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
induction- to-delivery interval time
Timepoint
24 hours after misoprostol and oxytocin administration
Method of measurement
clock
Secondary outcomes
1
Description
Induction complications
Timepoint
During inductoion procedurs
Method of measurement
Observation and phisical exam
Intervention groups
1
Description
comparison of induction of labor in misoprostol & oxytocin groups. one of two groups will get 200 micro gram vaginal tablet misoprostol and repeat after 12 hours if necessary.
Category
Treatment - Drugs
2
Description
Another group of patients will receive 50 units of oxytocin in 500 ml of dextrose- saline infusion over 3 hours, one hour of no oxytocin, followed by a 100 unit in 500 ml solution over 3 hours, another of rest , and a 150 units in 500 ml over 3 hours , the oxytocin will increased to a final concentration of 300 units in 500 ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariaty Hospital. Bandar Abas
Full name of responsible person
Dr. Zhila Abedi Asl
Street address
City
Bandar Abas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr. Abedi
Street address
Hormozgan-Bandar Abas . University of Medical Sciences
City
Bandar Abas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Maternl, fetal and neonatal research center, tehran Medical University