Back to resultsTheEffect of pH on Misoprostol in Induction of Labor
Primary Purpose
Labor Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
misoprostol in a neutral media
misoprostol in an acidic media
misoprostol in an alkaline media
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation
Exclusion Criteria:
- 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
Sites / Locations
- Algazeerah and Kasralainy hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Sham Comparator
Arm Label
misoprostol in neutral media
Misoprostol in acidic media
Misoprostol in alkaline media
Arm Description
Intervention : misoprostol in a neutral media will be given to women to induce labour
Intervention : misoprostol in acidic media will be given to induce labour
Intervention : misoprostol in alkaline media will be given to induce labour
Outcomes
Primary Outcome Measures
The number of women who will start lactive phase of labour after treatment
the number of women in a group who will enter in active labour faster than other groups
Secondary Outcome Measures
Full Information
NCT ID
NCT03829592
First Posted
February 1, 2019
Last Updated
May 16, 2020
Sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03829592
Brief Title
TheEffect of pH on Misoprostol in Induction of Labor
Official Title
TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
July 12, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .
Detailed Description
Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 paralle groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
misoprostol in neutral media
Arm Type
Placebo Comparator
Arm Description
Intervention : misoprostol in a neutral media will be given to women to induce labour
Arm Title
Misoprostol in acidic media
Arm Type
Active Comparator
Arm Description
Intervention : misoprostol in acidic media will be given to induce labour
Arm Title
Misoprostol in alkaline media
Arm Type
Sham Comparator
Arm Description
Intervention : misoprostol in alkaline media will be given to induce labour
Intervention Type
Drug
Intervention Name(s)
misoprostol in a neutral media
Other Intervention Name(s)
Drug (misoprostol + neutral media )
Intervention Description
giving misoprostol in a neutral media
Intervention Type
Drug
Intervention Name(s)
misoprostol in an acidic media
Other Intervention Name(s)
Drug ( Misoprostol + acidic media )
Intervention Description
giving misoprostol in an acidic media
Intervention Type
Drug
Intervention Name(s)
misoprostol in an alkaline media
Other Intervention Name(s)
Drug ( misoprostol + alkaline media )
Intervention Description
giving misoprostol in an alkaline media
Primary Outcome Measure Information:
Title
The number of women who will start lactive phase of labour after treatment
Description
the number of women in a group who will enter in active labour faster than other groups
Time Frame
within 24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Full term pregnant women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation
Exclusion Criteria:
1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy
Organizational Affiliation
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algazeerah and Kasralainy hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Learn more about this trial
TheEffect of pH on Misoprostol in Induction of Labor
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