IUDNCT05471362
Barriers of Immediate Postpartum Intrauterine Device Uptake
An observational study of IUD, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- IUD
- What is being tested?
- Postpartum IUD
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Feb 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 16 to 50 years
- Women only
- Child, Adult
Study population: Women aged from 16 to 50 who are pregnant and delivering in Assiut public hospitals via c-section
Who may be able to join
- 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
Who cannot join
- Women who delivered by vaginal delivery
- Women who delivered by emergency c-section
- women who has anomalies in the uterus
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Barriers of Immediate Postpartum Intrauterine Device Uptake in Assiut Public Hospitals
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
Read the 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.
- Conditions
- IUD
- Being tested
- Postpartum IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum IUDDevice
Postpartum IUD prevents pregnancy and short inter-pregnancy interval and allow spacing and family regulation
| Study group | Role | What they receive |
|---|---|---|
| Cases women who used IUD | Cases: women who had immediate Copper IUD inserted since October 2021 at the 4 public hospitals Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for IUDStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Maged Emile Hanna, Assiut University
- Investigators
- Omaima El Gibaly, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471362
- Sponsor's protocol ID
- Barriers of postpartum IUD
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27640082Holden 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.
PubMed 30455978Eltomy 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.
PubMed 24617117Divakar 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.
PubMed 31391742Hanna 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.
PubMed 40813660
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers of Immediate Postpartum Intrauterine Device Uptake in Assiut Public Hospitals
- ClinicalTrials.gov ID
- NCT05471362
- Acronym / sponsor ID
- Barriers of postpartum IUD
- Conditions
- IUD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Jul 2022 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases women who used IUD | – | Device: Postpartum IUDCases: women who had immediate Copper IUD inserted since October 2021 at the 4 public hospitals |
| Control women who didn't use IUD | – | –Controls: women who gave birth at the same hospitals and not using the immediate Copper IUD |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Women aged from 16 to 50 who are pregnant and delivering in Assiut public hospitals via c-section
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Women who delivered by vaginal delivery
- Women who delivered by emergency c-section
- women who has anomalies in the uterus
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 |
|---|---|---|
| Postpartum IUDPostpartum IUD prevents pregnancy and short inter-pregnancy interval and allow spacing and family regulation | Device | Cases women who used IUD |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 27640082Ganatra 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.
- Background: PubMed 30455978Holden 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.
- Background: PubMed 24617117Eltomy 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.
- Background: PubMed 31391742Divakar 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.
- Derived from this study: PubMed 40813660Hanna 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.
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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.
Omaima El Gibaly, PhD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of IUD, run by Assiut University.
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 5 inclusion and 3 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mireille Hanna, Bachelor's (+201110777565, miray.maged222@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 NCT05471362, which also lists 5 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 Jul 2022.