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NCT03829592 Clinical Trial

TheEffect of pH on Misoprostol in Induction of Labor

Labor Pain Clinical Trial

Official title:
TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03829592
Other study ID # Misoprostol
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 6, 2019
Est. completion date July 12, 2020

Study information
Verified date May 2020
Source Aljazeera Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date July 12, 2020
Est. primary completion date May 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 42 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• misoprostol in a neutral media
giving misoprostol in a neutral media
• misoprostol in an acidic media
giving misoprostol in an acidic media
• misoprostol in an alkaline media
giving misoprostol in an alkaline media

Locations
Country Name City State
Egypt Algazeerah and Kasralainy hospital Giza

Sponsors (2)
Lead Sponsor Collaborator
Aljazeera Hospital Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 within 24 hours
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