- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06273670
Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP) (KAP)
Regular Six Weeks Versus Earlier Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Family planning is a behavior that allows individuals and couples to anticipate and attain their desired number of children, at the spacing and timing of their births. It is achieved through the use of contraceptive methods and treatment of involuntary infertility.
Postpartum family planning is the prevention of unintended and closely spaced pregnancies during the first 12 months following childbirth. Short interval pregnancies are associated with increased maternal morbidities such as anemia, bleeding disorders, premature rupture of membranes, puerperal endometritis and mortality .
Postpartum family planning (PPFP) has long been recognized as an important component of maternal health care. Through birth spacing and prevention of high-risk and unwanted pregnancies, PPFP helps women who have recently delivered to avoid exposure to the risks of maternal death. Likewise, the importance of the interplay between maternal health services and use of contraception in the postpartum period has been recognized for decades.
Globally, more than 90 percent of women during the first year postpartum want to either delay or avoid future pregnancies . An increase in contraceptive use during the postpartum period should substantially reduce rates of maternal and infant mortality by preventing unplanned and unwanted pregnancies and by spacing new pregnancies at least two years after the previous birth .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nada M. Khalil, Diploma
- Phone Number: +201146640044
- Email: Topspot55@gmail.com
Study Contact Backup
- Name: Omar Mamdouh Shaaban, Doctorate
- Phone Number: +201061000250, +208824144661
- Email: omshaaban2000@yahoo.com
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Assiut University
-
Contact:
- mahmoud abdelaleem, Doctorate
- Phone Number: +201018880201
- Email: mahmaleem2000@yahoo.co.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Client's group:
All females visiting family planning centers in public health facilities who delivered within a year and receiving a LARC method or willing are asked to volunteer.
Service provider group:
All service providers who are working in primary health care units & hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers are asked to volunteer.
Description
Inclusion Criteria:
Client's group All clients who were attending family planning centers in public health facilities at the study period if they have had a postpartum LARC method (Copper IUD, Progestin-releasing IUS, Subdermal implant) or willing to use it in the first year after delivery.
Service provider group:
All service providers who are working in primary health care units & hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers.
Exclusion Criteria:
- Clients and service providers who refused to participate in the study
- Clients who are currently using or willing to use a method other than LARC
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Service providers
General practitioners, specialists, nurses, and social workers.
|
Structured questionnaire prepared in English and translated to local language (Arabic). The questionnaire is then linguistically validated by two forwards translations and one backward translation. Data was collected by the investigators who were not participating in the study. Personal or telephone interview will be conducted with clients and service providers conducted to collect the data. |
Clients
All clients who were attending family planning centers in public health facilities at the study period will be included if they have had a postpartum LARC method (Copper IUD, Progestin-releasing IUS or Subdermal implant) or willing to use it in the first year after delivery.
|
Structured questionnaire prepared in English and translated to local language (Arabic). The questionnaire is then linguistically validated by two forwards translations and one backward translation. Data was collected by the investigators who were not participating in the study. Personal or telephone interview will be conducted with clients and service providers conducted to collect the data. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clients' knowledge
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of clients who have good knowledge that LARC can be initiated early after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clients' attitude
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of clients who have positive attitude towards early initiation of LARC after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Clients' practice
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of clients who had previously or lately initiated any LARC early after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Providers' knowledge
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of providers who have good knowledge that LARC can be initiated early after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Providers' attitude
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of providers who have positive attitude towards early initiation of LARC after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Providers' practice
Time Frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
The percentage of providers who had previously or lately initiated any LARC for women early after delivery
|
Immediately. The outcome is provided in the questionnaire which is completed once by the client
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmed Ali Abdelaleem, Doctorate, Obstetrics and gynecology department, Assiut University
- Study Chair: Karim abdelhameed, Doctorate, Obstetrics and gynecology department, Assiut University
Publications and helpful links
General Publications
- Committee Opinion No. 642: Increasing Access to Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy. Obstet Gynecol. 2015 Oct;126(4):e44-e48. doi: 10.1097/AOG.0000000000001106.
- Washington CI, Jamshidi R, Thung SF, Nayeri UA, Caughey AB, Werner EF. Timing of postpartum intrauterine device placement: a cost-effectiveness analysis. Fertil Steril. 2015 Jan;103(1):131-7. doi: 10.1016/j.fertnstert.2014.09.032. Epub 2014 Oct 25.
- Conde-Agudelo A, Belizan JM. Maternal morbidity and mortality associated with interpregnancy interval: cross sectional study. BMJ. 2000 Nov 18;321(7271):1255-9. doi: 10.1136/bmj.321.7271.1255.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 04-2023-200279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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