The aim of the present study was to evaluate the effectiveness and the safety of orally administered misoprostol in comparison to intravenously infused oxytocin for labor induction in term pregnant women.
Between 2008 and 2010, a total of 285 term pregnant women whom were candidate for vaginal delivery assessed for eligibility to enter the study and were randomly assigned to one of two groups according to the method of treatment, misoprostol or oxytocin. The misoprostol group received 25 µg every two hours for up to 24 hours for induction. The oxytocin group received an infusion of 10 IU which was gradually increased. The time from induction to delivery and induction to the beginning of the active phase and successful inductions within 12, 18, and 24 hours were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061910068N1
Registration date:2012-07-05, 1391/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Aida Moeini
Name of organization / entity
Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
a.moeini64@gmail.com
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2008-01-01, 1386/10/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Induction and augmentation of labor with oral misoprostol versus oxytocin in term pregnancy: randomized controlled trial
Public title
Labor induction in term pregnant women of with oral misoprostol or oxytocin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term pregnant women whom were candidate for vaginal delivery; gestational age of 38 to 42 weeks; birth weight of maximally 4000 grams; normal fetal heart rate; cephalic presentation; lack of uterine contractures; single pregnancy and Bishop Score of six and less.
The exclusion criteria were lack of satisfaction for incorporation in the study; having a positive history of uterine surgery including cesarean; intrauterine growth retardation (IUGR); oligohydramnios; placenta previa; umbilical cord prolapse; active herpes infection; symptoms of chorioamnionitis; hepatic or renal disease; non-reactive contraindications for prostaglandins use; contraindications for labor induction and idiopathic vaginal bleeding.
Age
From 14 years old to 40 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
285
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Medical Sciences Ethics Committee
Street address
Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Postal code
Approval date
2007-10-01, 1386/07/09
Ethics committee reference number
69
Health conditions studied
1
Description of health condition studied
labor induction
ICD-10 code
O00-O08
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
The time from induction to delivery
Timepoint
12, 18, and 24 hours during labor
Method of measurement
Data recording
2
Description
The time from induction to the beginning of the active phase
Timepoint
12, 18, and 24 hours during labor
Method of measurement
Data recording
3
Description
Mode of delivery
Timepoint
12, 18, and 24 hours during labor
Method of measurement
Data recording
Secondary outcomes
1
Description
Maternal complications
Timepoint
Peri labor phase
Method of measurement
Data record
2
Description
Fetal and neonatal status
Timepoint
Peri labor phase
Method of measurement
Data record
Intervention groups
1
Description
In the oxytocin group, infusion rate of 2 mIU/min was prescribed for induction and gradually increased by 2 mIU/min every 15 minutes to a maximum dose of 36 mIU/min. In presence of any tachysystole (5 contractions in a 10-minute interval) or hypertonus (single contractions lasting 2 minutes or longer), or changes in fetal heart rate associated with tachysystole or hypertonus, infusion rate was decreased or stopped.
Category
Treatment - Drugs
2
Description
Initiation of labor induction was the time at which the first misoprostol dose was administered (group 1) or the oxytocin infusion was started (group 2).
In the misoprostol group, a tablet of 200 µg was dissolved in 200cc of water and 25cc was administered every two hours for up to 24 hours (10). The maximum dose was 300 µg. If the ideal pattern of contractions (at least 3 contractions per 10 minutes) was reached, misoprostol was no longer administered.
ّFetal heart monitoring and uterine contraction were also recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Seyed Jalaledin Khoshnevis
Street address
Shohada Hospital - Tajrish square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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
Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science
Full name of responsible person
Aida Moeini
Position
M.D.
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2271 8000
Fax
Email
a.moeini64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science
Full name of responsible person
Rezvan Aalami-Harandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2271 8000
Fax
Email
mahmaz2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science
Full name of responsible person
Aida Moeini
Position
M.D.
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2271 8000
Fax
Email
a.moeini64@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)