Comparing cervical foley catheter and vaginal misoprostol in simplification of labor delivery
Design
This study is a randomized clinical trial which was conducted in the delivery and women hospital of Bandar- Abbas in 2016-2017. In this study 120 randomized postdate primigravid women between 18-35 yeares old who suffered from vaginal bleeding, abnormal fetal heartbeat, natural disease that needed to terminate the pregnancy season, misoprostol susceptibility and weren't utrine scar were selected. They were randomly divided into two groups of 60. In one group cervical foley catheter and in another one vaginal misoprostol 25 microgram was used.
Settings and conduct
This study is a randomized clinical trial which was conducted in the delivery and women hospital of Bandar- Abbas in 2016-2017. In this study 120 randomized postdate primigravid women between 18-35 yeares old who suffered from vaginal bleeding, abnormal fetal heartbeat, natural disease that needed to terminate the pregnancy season, misoprostol susceptibility and weren't utrine scar were selected. They were randomly divided into two groups of 60. In one group cervical foley catheter and in another one vaginal misoprostol 25 microgram was used. In terms of delivery progress need of oxytocin, Apgar score, delivery time, NICU requirement, meconium- stained amniotic fluid were examined. T
Participants/Inclusion and exclusion criteria
In this study 120 randomized postdate primigravid women between 18-35 yeares old who suffered from vaginal bleeding, abnormal fetal heartbeat, natural disease that needed to terminate the pregnancy season, misoprostol susceptibility and weren't utrine scar were selected.
Intervention groups
In one group cervical foley catheter and in another one vaginal misoprostol 25 microgram was used.
Main outcome variables
Time of normal vaginal delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042033N4
Registration date:2020-04-19, 1399/01/31
Registration timing:retrospective
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Nazanin Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
abdinazanin834@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
2017-08-15, 1396/05/24
Actual recruitment end date
2018-03-18, 1396/12/27
Trial completion date
2018-03-18, 1396/12/27
Scientific title
Comparison of vaginal misoprostol and intra cervical foleycatheter for cervical ripening of postdate primigravid women
Public title
Comparison of vaginal misoprostol and intra cervical foleycatheter for cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravid women
18-35 yeares old
Vaginal bleeding
Abnormal fetal heartbeat
Natural disease that needed to terminate the pregnancy season
Exclusion criteria:
Misoprostol susceptibility
Uterine scar
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar bottles
Blinding (investigator's opinion)
Single blinded
Blinding description
Our colleague in this study in hospital delivered formulations to the participants of the study according to the randomized block table.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Homozgan University of medical sciences
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas