Effectiveness of Evening Primrose Oil for Induction of Labor

August 2, 2024 updated by: sayed mohamed sayed mostafa, Assiut University
Effectivness of primrose oil in induction of labour .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • pregenent of 38 weeks and longer
  • singleton pregenency
  • vertex presentation
  • indication of labor induction
  • bishop score <6 and cervical dilation<2 cm

Exclusion Criteria:

  • women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
  • women with multiple gestation
  • women with evidence of low implanted placenta by ultrasound
  • women with contraindication to misoprostol or vaginal delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Evening primrose oil + misoprostol
combination of both drugs for induction of labor adminstrated vaginally.
Drug: Evening Primrose Oil 1000 MG
Evening primrose oil 1000mg vaginally plus misoprostal for induction of labor
Other: misoprostol only
misoprostol alone for induction of labor adminstrated vaginally.
Drug: Evening Primrose Oil 1000 MG
Evening primrose oil 1000mg vaginally plus misoprostal for induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The interval between induction of labor and delivery
Time Frame: induction of labor may take more than 24 hours
comparing between the interval between induction of labor and delivery in two groups one is using evening primrose oil + misoprostol and the other using misoprostol only.
induction of labor may take more than 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2024

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

October 12, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • primrose oil in labor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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