NCT05471362

Brief Summary

increase immediate postpartum intrauterine device uptake and support family planning programs to overcome barriers and increase contraception prevalence rate in Egypt determine client related barriers of immediate postpartum intrauterine device uptake in Assiut Hospitals (Demand side) identify provider related barriers of immediate postpartum intrauterine device uptake in Assiut Hospitals (Supply side) describe method related barriers perceived by women

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 17, 2022

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Identifying the different barriers of uptake of immediate Postpartum copper Intrauterine device on the demand side; barriers to immediate postpartum uptake of the intrauterine device as perceived by the clients

    Determining client related barriers of uptake of immediate postpartum copper intrauterine device in Assiut public Hospitals (Demand side) and identifying the most common barriers wether it is Cognitive; if she ever heard about Immediate postpartum intrauterine device, source of information and when was she informed about the method (during antenatal care or Delivery) and her knowledge about Immediate postpartum intrauterine device or wether it is Cultural \& family factors; fertility preferences of couple, husband's or family disapproval of using contraception, fear of use due to myths and misconception, cultural preference of pregnancy in young age and the belief that untraditional contraception harm the health

    Baseline

  • Identifying the different barriers of uptake of immediate Postpartum copper Intrauterine device on the supply side; barriers as perceived by the physicians and nurses and other barriers related to the facility

    Identifying the barriers of uptake of immediate Postpartum copper Intrauterine device on the supply side; barriers to immediate postpartum uptake of the intrauterine device as perceived by the physicians and nurses and in the facility in Assiut public hospitals such as provider personal preference, negative attitude of the hospital staff towards immediate postpartum intrauterine device, Perceived poor quality of care in the facility, previous personal or a relatives' bad experience with the facility, shortage of stock on the supply of intrauterine device in delivery settings, bad providers attitude towards pregnant women, lack of access to Postpartum intrauterine device during delivery and cost of the IUD

    Baseline

  • Identifying the method related barriers to immediate postpartum uptake of the intrauterine device as perceived by women in Assiut public hospitals

    Describing method related barriers perceived by women such as fear of side effects, tried it before and failed, used it before and caused bleeding or pain, want the best available method, wants to try other methods, already uses a certain method and doesn't wish to change and attitude towards postpartum intrauterine device

    Baseline

Study Arms (2)

Cases women who used IUD

Cases: women who had immediate Copper IUD inserted since October 2021 at the 4 public hospitals

Device: Postpartum IUD

Control women who didn't use IUD

Controls: women who gave birth at the same hospitals and not using the immediate Copper IUD

Interventions

Postpartum IUD prevents pregnancy and short inter-pregnancy interval and allow spacing and family regulation

Cases women who used IUD

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women delivering via C-Section
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged from 16 to 50 who are pregnant and delivering in Assiut public hospitals via c-section

You may qualify if:

  • Women who gave birth via elective Cesarian Section at 4 public hospitals in Assiut city from October 2021:
  • woman who gave birth via elective c-section at Women Health hospital of Assiut University from October 2021
  • women who gave birth via elective c-section at Assiut General Hospital from October 2021
  • women who gave birth at via elective c-section El-Eman El-Arbaeen from October 2021
  • women who gave birth at via elective c-section El-Mabarra from October 2021

You may not qualify if:

  • Women who delivered by vaginal delivery
  • Women who delivered by emergency c-section
  • women who has anomalies in the uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Ganatra B, Faundes A. Role of birth spacing, family planning services, safe abortion services and post-abortion care in reducing maternal mortality. Best Pract Res Clin Obstet Gynaecol. 2016 Oct;36:145-155. doi: 10.1016/j.bpobgyn.2016.07.008. Epub 2016 Aug 3.

    PMID: 27640082BACKGROUND
  • Holden EC, Lai E, Morelli SS, Alderson D, Schulkin J, Castleberry NM, McGovern PG. Ongoing barriers to immediate postpartum long-acting reversible contraception: a physician survey. Contracept Reprod Med. 2018 Nov 8;3:23. doi: 10.1186/s40834-018-0078-5. eCollection 2018.

    PMID: 30455978BACKGROUND
  • Eltomy EM, Saboula NE, Hussein AA. Barriers affecting utilization of family planning services among rural Egyptian women. East Mediterr Health J. 2013 May;19(5):400-8.

    PMID: 24617117BACKGROUND
  • Divakar H, Bhardwaj A, Purandare CN, Sequeira T, Sanghvi P. Critical Factors Influencing the Acceptability of Post-placental Insertion of Intrauterine Contraceptive Device: A Study in Six Public/Private Institutes in India. J Obstet Gynaecol India. 2019 Aug;69(4):344-349. doi: 10.1007/s13224-019-01221-7. Epub 2019 May 10.

    PMID: 31391742BACKGROUND
  • Hanna MM, El Gibaly O, Fathalla MMF, Mohammed HM. Exploring barriers and facilitators to immediate postpartum intrauterine device uptake within the strengthening Egypt family planning program: a case-control study. BMC Health Serv Res. 2025 Aug 14;25(1):1081. doi: 10.1186/s12913-025-13306-3.

Study Officials

  • Omaima El Gibaly, PhD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mireille Hanna, Bachelor's

CONTACT

Omaima El Gibaly, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at the Public Health Department

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 22, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

July 22, 2022

Record last verified: 2022-07