- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471362
Barriers of Immediate Postpartum Intrauterine Device Uptake
Barriers of Immediate Postpartum Intrauterine Device Uptake in Assiut Public Hospitals
Study Overview
Detailed Description
Population increase in Egypt is a major problem with the fertility rate 3.5 children per woman the postpartum period starts after the birth of the placenta and lasts for 6-8weeks after delivery Women resume sexual activity 1 to 2 months after delivery, with 45-day average till return of ovulation. women returning for intrauterine device insertion 6-8 weeks are at risk of unintended pregnancy Insertion of postpartum intrauterine device is immediate or interval. immediate Postpartum intrauterine device inserted from the placental delivery time (within 10 minutes), or within first 48 hours, it can be done after vaginal or caesarean.
Postpartum intrauterine device can improve mothers' health by reducing difficulties from closely spaced pregnancies Immediate postpartum intrauterine device uptake is low in most developing countries and Egypt due to several barriers
- Health facility: provider knowledge, attitude, lack of training, counseling, privacy, shortage of supply of intrauterine device,poor quality of service, bad experience with the facility
- Community: as Sociodemographic (desire more children), cultural norms, husband opposition, and religious beliefs , fear of side effects., Cognitive (didn't hear about family planning in past 6 months), reproductive (long interval between intercourse), medical (requiring checkups) physical (distance of clinic) The rational is postpartum women are motivated to avoid pregnancy, 90% of women deliver in hospitals, they are in facilities with skilled physicians who can offer contraception. Immediate postpartum intrauterine device is cost-effective and efficient Assiut implemented a program training physicians on immediate Postpartum intrauterine device insertion in 2021.
This study will support the newly implemented program to overcome barriers from demand and supply sides and direct the program to future activity.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mireille Hanna, Bachelor's
- Phone Number: +201110777565
- Email: miray.maged222@med.aun.edu.eg
Study Contact Backup
- Name: Omaima El Gibaly, PhD
- Phone Number: +201223971259
- Email: oelgibaly@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Women who delivered by vaginal delivery
- Women who delivered by emergency c-section
- women who has anomalies in the uterus
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases women who used IUD
Cases: women who had immediate Copper IUD inserted since October 2021 at the 4 public hospitals
|
Postpartum IUD prevents pregnancy and short inter-pregnancy interval and allow spacing and family regulation
|
Control women who didn't use IUD
Controls: women who gave birth at the same hospitals and not using the immediate Copper IUD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Omaima El Gibaly, PhD, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- Barriers of postpartum IUD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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