Prolonged labor is a common problem, especially among nulliparous women. It can result in a negative birth experience. The aim of the present study is to evaluate the effectiveness and the safety of orally administered misoprostol for labor augmentation among women at 36 to 42 weeks of gestation with spontaneous onset of active labor and compare it with intravenously infused oxytocin. A total of 250 term pregnant women with spontaneous onset of active labor whom are candidate for vaginal delivery assess for eligibility to enter the study. Women meeting the general selection criteria with regular contractions and an effaced cervix dilated between 3 and 9 cm, and who have inadequate uterine contractions (two or fewer contractions every 10 minutes) during the first stage of labor, were randomly assigned to titrated oral misoprostol or intravenous oxytocin. The misoprostol group received 25 µg every two hours (maximum doses of 300µg). The oxytocin group received an infusion of 10 IU which was gradually increased. Our study was designed to carry out between 2009 and 2011. The primary parameters used to evaluate efficacy were the interval from the start of augmentation to vaginal delivery and the percentage of women who delivered their newborns vaginally within 12 or 24 hours of this interval. Maternal and neonatal complications were also assessed between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102910068N2
Registration date:2012-11-28, 1391/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
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
2009-01-01, 1387/10/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of oral Misoprostol versus Oxytocin on labor augmentation in pregnant women
Public title
comparison of Misoprostol with Oxytocin on labor augmentation in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnancy between 36 and 42 weeks of gestation; a live singleton fetus in cephalic presentation; no history of uterine surgery; spontaneous onset of active labor with regular contractions; an effaced cervix dilated between 3 cm and 9 cm; a reassuring fetal heart rate (FHR) pattern.
Exclusion criteria:
nonreassuring FHR pattern; parity greater than five; any contraindication to labor or vaginal delivery or both; epidural analgesia; significant maternal cardiac; renal or hepatic disease; hypersensitivity to misoprostol or prostaglandin analogues.
Age
From 16 years old to 45 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
250
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 science
Street address
Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Postal code
Approval date
2008-08-01, 1387/05/11
Ethics committee reference number
310
Health conditions studied
1
Description of health condition studied
Long labour
ICD-10 code
O63.1
ICD-10 code description
Prolonged second stage (of labour)
Primary outcomes
1
Description
the time from augmentation to vaginal delivery
Timepoint
12 and 24 hours during labor
Method of measurement
data recording
2
Description
mode of delivery
Timepoint
12 and 24 hours during labor
Method of measurement
data recording
Secondary outcomes
1
Description
Fetal and neonatal status
Timepoint
peri labor phase
Method of measurement
data record
2
Description
maternal complications
Timepoint
peri labor phase
Method of measurement
data record
Intervention groups
1
Description
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. The maximum dose was 300 µg.
Fetal heart monitoring and uterine contraction were also recorded.
Adequate uterine contractions were defined as three or more in 10 minutes over 30-minute windows. Once uterine activity was adequate over 1 hour, no further misoprostol was given.
Category
Treatment - Drugs
2
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Rezvan Aalami-Harandi
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science
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)