- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901639
Postpartum Contraception Counseling on the Rate of Unintended Pregnancy
June 26, 2018 updated by: Ahmed Mohamed Abbas, Assiut University
Influence of Immediate Postpartum Contraception Counseling on the Rate of Unintended Pregnancy in Primigravida: A Randomized Controlled Study
Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries.
According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted.
Unintended pregnancy also is a major health problem in the United States of America.
In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended.
When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Assiut, Cairo, Egypt, 002
- Recruiting
- Ahmed Abbas
-
Contact:
- ahmed abbas
- Email: bmr90@hotmail.com
-
-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age: above 18 years
- Primigravida
- Women who will accept to participate in
Exclusion Criteria:
- Women who are not intended to use contraception
- Multiparous
- Women who refuse to participate in the study
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: counseling group
will receive counseling about contraceptive methods using illustrations through postpartum interview with the study
|
|
No Intervention: NO counseling
will not receive any counseling about contraceptive methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in the rate of unintended pregnancy in both groups
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
September 1, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
September 10, 2016
First Submitted That Met QC Criteria
September 10, 2016
First Posted (Estimate)
September 15, 2016
Study Record Updates
Last Update Posted (Actual)
June 27, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PPCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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