TheEffect of pH on Misoprostol in Induction of Labor

TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies

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 .

Study Overview

• Status: Unknown
• Conditions: Labor Pain
• Intervention / Treatment: Drug: misoprostol in a neutral media; Drug: misoprostol in an acidic media; Drug: misoprostol in an alkaline media

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

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Algazeerah and Kasralainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: misoprostol in neutral media; Intervention : misoprostol in a neutral media will be given to women to induce labour	Drug: misoprostol in a neutral media; giving misoprostol in a neutral media; Other Names: Drug (misoprostol + neutral media )
Active Comparator: Misoprostol in acidic media; Intervention : misoprostol in acidic media will be given to induce labour	Drug: misoprostol in an acidic media; giving misoprostol in an acidic media; Other Names: Drug ( Misoprostol + acidic media )
Sham Comparator: Misoprostol in alkaline media; Intervention : misoprostol in alkaline media will be given to induce labour	Drug: misoprostol in an alkaline media; giving misoprostol in an alkaline media; Other Names: Drug ( misoprostol + alkaline media )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): May 10, 2020
• Study Completion (Anticipated): July 12, 2020

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 16, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Misoprostol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No