NCT06273670

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

July 15, 2023

Last Update Submit

February 14, 2024

Conditions

Keywords

Postpartum contraceptionLARCKAP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Clients' attitude

    Immediately. The outcome is provided in the questionnaire which is completed once by the client

  • Clients' practice

    Immediately. The outcome is provided in the questionnaire which is completed once by the client

  • Providers' knowledge

    Immediately. The outcome is provided in the questionnaire which is completed once by the client

  • Providers' attitude

    Immediately. The outcome is provided in the questionnaire which is completed once by the client

  • Providers' practice

    Immediately. The outcome is provided in the questionnaire which is completed once by the client

Study Arms (2)

Service providers

General practitioners, specialists, nurses, and social workers.

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.

Other: screening and data collection

Interventions

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.

ClientsService providers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related 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.

    PMID: 26393458BACKGROUND
  • 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.

    PMID: 25439838BACKGROUND
  • 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.

MeSH Terms

Interventions

Mass ScreeningData Collection

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Ahmed Ali Abdelaleem, Doctorate

    Obstetrics and gynecology department, Assiut University

    STUDY CHAIR
  • Karim abdelhameed, Doctorate

    Obstetrics and gynecology department, Assiut University

    STUDY CHAIR

Central Study Contacts

Nada M. Khalil, Diploma

CONTACT

Omar Mamdouh Shaaban, Doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 15, 2023

First Posted

February 22, 2024

Study Start

June 15, 2023

Primary Completion

December 1, 2024

Study Completion

October 1, 2025

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations