Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)

Contraception Clinical Trial

— KAP  

Official title:

Regular Six Weeks Versus Earlier Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273670
• Other study ID #: 04-2023-200279
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Nada M. Khalil, Diploma
• Phone: +201146640044
• Email: Topspot55[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• screening and data collection
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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clients' knowledge	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	Clients' attitude	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
Secondary	Clients' practice	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
Secondary	Providers' knowledge	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
Secondary	Providers' attitude	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
Secondary	Providers' practice	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