Contraception BehaviorNCT03106805
Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion
A study testing early insertion and late insertion in people with Contraception Behavior, run by Assiut University at 1 site in Egypt.
Trial summary
The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- early insertion and late insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to Mar 2022
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.
Who cannot join
- Known uterine anomalies.
- Women with previous ectopic pregnancy.
- Presence of postpartum pyrexia.
- Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
- Retained products of conception.
- History of previous uterine perforation.
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- Anticipation of difficulty of subsequent follow-up with the women.
- Women with uncontrolled diabetes and hypertension.
- Women who wish to use other contraceptive methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial
The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals
- Conditions
- Contraception Behavior
- Being tested
- early insertion, late insertion
- Keywords
- intrauterine device
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early insertionProcedure or surgery
insertion at 4th postpartum week
late insertionProcedure or surgery
insertion at 6th postpartum week
| Study group | Role | What they receive |
|---|---|---|
| insertion by the end of the 4th week postpartum | Experimental | Not described Receives: Procedure: early insertion |
| insertion by the end of the 6th week postpartum | Active comparator | Not described Receives: Procedure: late insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants use the device
number of women place the intrauterine device within 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Jul 2017
- Primary completionNov 2021 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraception BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
- Investigators
- Ahmed Abbas, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106805
- Sponsor's protocol ID
- EAIUD
- Status last verified
- May 2022
- First submitted
- 4 Apr 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.
PubMed 27405702
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03106805
- Acronym / sponsor ID
- EAIUD
- Conditions
- Contraception Behavior
- Keywords
- intrauterine device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Apr 2017 (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.
The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insertion by the end of the 4th week postpartum | Experimental | Procedure: early insertion |
| insertion by the end of the 6th week postpartum | Active comparator | Procedure: late insertion |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.
Key exclusion criteria (9 listed)
- Known uterine anomalies.
- Women with previous ectopic pregnancy.
- Presence of postpartum pyrexia.
- Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
- Retained products of conception.
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 |
|---|---|---|
| early insertioninsertion at 4th postpartum week | Procedure or surgery | insertion by the end of the 4th week postpartum |
| late insertioninsertion at 6th postpartum week | Procedure or surgery | insertion by the end of the 6th week postpartum |
Primary outcome
The number of participants use the device
Time frame: 6 weeks
number of women place the intrauterine device within 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 27405702Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.
- Individual participant dataSharing planned: No
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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.
Ahmed Abbas, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early insertion and late insertion in people with Contraception Behavior, 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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 May 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants use the device (time frame: 6 weeks). 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 NCT03106805, which also lists 1 linked publication.
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 11 May 2022.