Protocol summary

Summary
Objective: Investigation the success rate of Estradiol in combination with Misoprostol in labor induction Design: Noting to Estradiol leads to an increase in Prostaglandin production, and Prostaglandin has a important role in onset of labor, we decided to investigate the effect of Estradiol on induction of labor. Setting and conduct: This study is a prospective clinical trial, double blind and randomization, with control group. The study will be performed in the Hospitals of Mashhad University of Medical Sciences on pregnant women who gestational age is upper 36 weeks and cervix is undesirable , and has indication of the termination of pregnancy will be done. The randomization is done by using closed envelopes by placing the referee for treatment in the envelope. Inclusion criteria included: Gestational age over 36 weeks, singleton pregnancy with a vertex presentation, the absence of contraindications to vaginal delivery, there is no indication for emergency childbirth, no history of liver and kidney disease, no history of fetal distributors, no history of contraindications use Misoprostol (such as the mother's risk of blood coagulation disorders, asthma, glaucoma, etc.).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120920264N1
Registration date: 2017-10-29, 1396/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Seyedeh Azam Pourhoseini
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 1446
Email address
pourhoseinia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of misoprostol / ‎estradiol compared with ‎misoprostol in labor ‎induction ‎
Public title
Comparison of the effect of letrozole /Estradiol and Misoprostol in labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age over 36 weeks; singleton pregnancy with a vertex presentation; the absence of contraindications to vaginal delivery Exclusion criteria: Indication for emergency childbirth; History of liver and kidney disease; History of fetal distributors; History of contraindications use misoprostol (such as the mother's risk of blood coagulation disorders, asthma, glaucoma, etc).
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Street address
daneshgah St, Ghoreish department Mashhad , Islamic Republic Of Iran
City
Mashhad
Postal code
13944-91388 :
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
922107

Health conditions studied

1

Description of health condition studied
labor
ICD-10 code
O96.0
ICD-10 code description
Death from direct obstetric cause

Primary outcomes

1

Description
cervical ripening
Timepoint
The Bishop score less than 4 until the Bishop score of above 7
Method of measurement
vaginal exam

Secondary outcomes

1

Description
Duration of delivery
Timepoint
Every 4 hours
Method of measurement
vaginal exam

Intervention groups

1

Description
Intervention group:In this group, 25 microgram of Misoprostol vaginal cervix to start preparing favorable with 50 Micrograms of Estradiol (two pills Vagifom witch each pill contains 25 micrograms of Estradiol ) will be used.
Category
Treatment - Drugs

2

Description
Control group: In this group to begin to prepare a favorable cervix, vaginal 25 micrograms of Misoprostol will be used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolalbanin Hospital
Full name of responsible person
seyedeh azam pourhoseini
Street address
Omolalbanin Hospital, Ayatolah Bahjat Street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St., Mashhad. Mashhad
City
Mashhad
Grant name
Grant code / Reference number
922107
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Azam Pourhoseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Postal code
13944-91388
Phone
+98 51 3802 2608
Fax
+98 51 3843 0249
Email
pourhoseinia@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
seyedeh azam pourhoseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square.
City
Mashhad
Postal code
7449389918
Phone
+98 51 3802 2608
Fax
Email
pourhoseinia@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
seyedeh azam pourhoseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Postal code
7449389918
Phone
+98 51 3802 2608
Fax
Email
pourhoseinia@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...