The effect of outpatient sublingual misoprostol 25 µg and oral misoprostol 50 µg on reducing post-term pregnancy and induction success and evaluation of maternal and fetal outcomes: a double-blind clinical trial
Determining the effect of outpatient misoprostol on cervical preparation and reduction of post-term pregnancy and delivery induction success
Design
In this double-blind clinical trial study, the sample size of patients was 70 pregnant women in each group (group A, B). Participants are selected from pregnant mothers who visit the midwifery clinic of Umm al-Banin and Imam Reza and Ghaem hospitals.
Settings and conduct
The midwifery clinic of Umm al-Banin and Imam Reza and Ghaem hospitals
Participants/Inclusion and exclusion criteria
Inclusion criteria included gestational age 40 weeks (based on first trimester ultrasound) and gravid primordia and monocytogenesis, cephalic presentation, normal amniotic fluid (AFI greater than or equal to 5 cm), no history of medical and midwifery and Bishab Score is less than 8 and the mother is between 18 and 40 years old, with no uterine contractions.
Intervention groups
A group of patients taking Misoprostol 25 mg sublingual tablets and a group of Misoprostol tablets 50 micrograms oral will be given at a specific time of pregnancy.
Main outcome variables
Duration of Cervical Preparation to Delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045653N1
Registration date:2020-02-14, 1398/11/25
Registration timing:registered_while_recruiting
Last update:2020-02-14, 1398/11/25
Update count:0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
sara partanezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 8409
Email address
partans941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-04, 1398/09/13
Expected recruitment end date
2020-12-03, 1399/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of outpatient sublingual misoprostol 25 µg and oral misoprostol 50 µg on reducing post-term pregnancy and induction success and evaluation of maternal and fetal outcomes: a double-blind clinical trial
Public title
sublingual misoprostol 25 µg and oral misoprostol 50 µg on reducing post-term pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Maximum gestational age of 40 weeks
pregnant women
Prime Grave
Single pregnancy
Cephalic display
Having normal amniotic fluid (AFI greater than or equal to 5 cm)
Bishop Score less than 8
Maternal age between 18 and 40 years
Exclusion criteria:
History of medical and midwifery disease
Diabetes
Preeclampsia
History of stillbirth
Opt out of the study
Improper use of medication
Age
From 18 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly divided into treatment groups A and B using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
researcher and Statistical analyzer are unaware of the dose of the drug being prescribed and the method of administration.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences