Protocol summary
-
Study aim
-
Comparison of the effect of misoprostol alone and misoprostol together with vaginal estrogen in preparing the cervix and induction of labor in term pregnancies
-
Design
-
This three-phase clinical trial, with parallel groups, randomized (using the allocation randomization rule) is performed on 200 pregnant women.
-
Settings and conduct
-
In this interventional study, 200 pregnant women are selected by convenience sampling method in Yas Hospital. This study is double-blind, the participants and the physician who evaluates the outcome are kept blind.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria include term pregnancy (Gestational age >37 weeks), nulliparous woman, singleton pregnancy, and alive Fetus with the cephalic presentation, and Bishop score < 5. Exclusion criteria: Misoprostol or estrogen contraindication, women with a history the uterus surgery, and a history or family history of thromboembolism.
-
Intervention groups
-
In both groups, For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. In the intervention group, in the first and second times of misoprostol administration, an applicator of Stromarin (estrogen) cream is also placed in the posterior part of the vagina.
-
Main outcome variables
-
The interval from induction with misoprostol to the attainment of 6 cm cervical dilation, from 6 cm cervical dilation to full cervical dilation, and from full cervical dilation to active phase of labor.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20230611058454N1
Registration date:
2023-06-24, 1402/04/03
Registration timing:
prospective
Last update:
2023-07-25, 1402/05/03
Update count:
1
-
Registration date
-
2023-06-24, 1402/04/03
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-07-23, 1402/05/01
-
Expected recruitment end date
-
2024-08-21, 1403/05/31
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparison of the effect of misoprostol alone and misoprostol together with vaginal estrogen in preparing the cervix and induction of labor in term pregnancies
-
Public title
-
The effect of misoprostol alone and misoprostol together with vaginal estrogen in induction of labor
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Term pregnancy (Gestational age >37 weeks)
Nulliparous woman
Singleton pregnancy
Alive Fetus with cephalic presentation
Bishop score < 5
Exclusion criteria:
Misoprostol or estrogen contraindication
Women with a history the uterus surgery
Women with a history or family history of thromboembolism
-
Age
-
No age limit
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
200
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Random allocation rule: First, 100 letters A and 100 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A
(misoprostol) or B (misoprotol and estrogen) are determined by a lot.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
This study is performed double-blind, the physician evaluating outcomes and the participants do not know the type of treatment.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-06-11, 1402/03/21
-
Ethics committee reference number
-
اخلاق: IR.TUMS.MEDICINE.REC.1402.171
Health conditions studied
1
-
Description of health condition studied
-
Labor induction
-
ICD-10 code
-
O61.0
-
ICD-10 code description
-
Failed medical induction of labor
Primary outcomes
1
-
Description
-
Interval from induction with misoprostol to the attainment of 6 cm cervical dilation
-
Timepoint
-
Once, after delivery
-
Method of measurement
-
Information entered in the patient's delivery record
2
-
Description
-
Interval from 6 cm cervical dilation to full cervical dilation
-
Timepoint
-
Once, after delivery
-
Method of measurement
-
Information entered in the patient's delivery record
3
-
Description
-
Interval from full cervical dilation to active phase of labor
-
Timepoint
-
Once, after delivery
-
Method of measurement
-
Information entered in the patient's delivery record
Intervention groups
1
-
Description
-
Intervention group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. In the first and second times of misoprostol administration, an applicator of Stromarin (estrogen) cream is also placed in the posterior part of the vagina.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
All data is potentially shareable after unidentified participants.
-
When the data will become available and for how long
-
After the manuscript is published.
-
To whom data/document is available
-
No limitations.
-
Under which criteria data/document could be used
-
The data is only available to the project manager, Dr. Golshahi, and any analysis must be done with her opinion.
-
From where data/document is obtainable
-
Dr. Golshahi.
-
What processes are involved for a request to access data/document
-
Any request must be sent by e-mail with its proposal to Dr. Golshahi.
-
Comments
-