ContraceptionKAPNCT06273670
Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- screening and data collection
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
mahmoud abdelaleem, Doctorate, +201018880201, mahmaleem2000@yahoo.co.uk
About this study
Official title: Regular Six Weeks Versus Earlier Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)
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.
Read the 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 .
- Conditions
- Contraception
- Being tested
- screening and data collection
- Keywords
- Postpartum contraception, LARC, KAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening and data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Service providers | General practitioners, specialists, nurses, and social workers. Receives: Other: screening and data collection | |
| 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. Receives: Other: screening and data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clients' knowledge
The percentage of clients who have good knowledge that LARC can be initiated early after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Secondary outcomes (5)
Clients' attitude
The percentage of clients who have positive attitude towards early initiation of LARC after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Clients' practice
The percentage of clients who had previously or lately initiated any LARC early after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Providers' knowledge
The percentage of providers who have good knowledge that LARC can be initiated early after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Providers' attitude
The percentage of providers who have positive attitude towards early initiation of LARC after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Providers' practice
The percentage of providers who had previously or lately initiated any LARC for women early after delivery
Measured: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mahmoud M. Khalil, Assiut University
- Investigators
- Ahmed Ali Abdelaleem, Doctorate, Study chair, Obstetrics and gynecology department, Assiut UniversityKarim abdelhameed, Doctorate, Study chair, Obstetrics and gynecology department, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273670
- Sponsor's protocol ID
- 04-2023-200279
- Acronym
- KAP
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26393458Washington 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.
PubMed 25439838Conde-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.
PubMed 11082085
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Six Weeks Versus Earlier Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)
- ClinicalTrials.gov ID
- NCT06273670
- Acronym / sponsor ID
- KAP / 04-2023-200279
- Conditions
- Contraception
- Keywords
- Postpartum contraception, LARC, KAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Service providers | – | Other: screening and data collectionGeneral practitioners, specialists, nurses, and social workers. |
| Clients | – | Other: screening and data collectionAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- All service providers who are working in primary health care units \& hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening and data collectionStructured 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. | Other | Clients, Service providers |
Primary outcome
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
5 secondary outcomes
Clients' attitude
Time frame: 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
Providers' knowledge
Time frame: 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
Providers' practice
Time frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 26393458Committee 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.
- Background: PubMed 25439838Washington 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.
- Results publication: PubMed 11082085Conde-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.
- Individual participant dataSharing planned: Undecided
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Ali Abdelaleem, Doctorate study chair
Obstetrics and gynecology department, Assiut University
Karim abdelhameed, Doctorate study chair
Obstetrics and gynecology department, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada M. Khalil, Diploma (+201146640044, Topspot55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clients' knowledge (time frame: Immediately. The outcome is provided in the questionnaire which is completed once by the client). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.