ContraceptionPPIUDNCT01175161
Postpartum Intrauterine Device Study
A study testing Copper T380A Intrauterine Device in people with Contraception and Intrauterine Devices, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Intrauterine Devices, Pilot Study
- What is being tested?
- Copper T380A Intrauterine Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2010to Jun 2011
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary Inclusion Criteria:
- Ages 18-45 attending prenatal care
- Greater than 34 weeks estimated gestational age
- Desire to use the CuT380A-IUCD for contraception postpartum
- Plan to stay in the area for at least 5 months postpartum
- If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
Show all 22Show fewer
- No prior cesarean delivery
- No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
- No known uterine anomalies
- No known pelvic tuberculosis
- No known genital tract cancer
- No known allergy to copper
- No known history of ectopic pregnancy within 3 months prior to pregnancy.
- No evidence of clinical anemia as assessed by a clinician at enrollment
- Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery
- Secondary Eligibility Criteria
- Vaginal delivery within the last 48 hours
- No postpartum hemorrhage documented by the delivering clinician
- Not known to have ruptured membranes for greater than 24 hours prior to delivery
- No infection diagnosed by a clinician
- No fever of greater than 38° during labour or delivery
- Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.
Who cannot join
- prior cesarean section
- fever during labor and delivery
- AIDS, not well on antiretroviral therapy
- genital tuberculosis
- known uterine abnormalities or genital tract cancer
- history of ectopic pregnancy within 3 months of current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.
The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.
Read the detailed description
Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.
- Conditions
- Contraception, Intrauterine Devices, Pilot Study, Africa
- Being tested
- Copper T380A Intrauterine Device
- Keywords
- Postpartum Contraception, Intrauterine device, feasibility, IUD, Immediate postpartum IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper T380A Intrauterine DeviceDevice
the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Immediate postpartum IUD insertion | Experimental | Women assigned to have the IUD placed 10 minutes to 48 hours postpartum Receives: Device: Copper T380A Intrauterine Device |
| 6 week postpartum IUD insertion | Experimental | Women who receive the IUD at the traditional time frame. Receives: Device: Copper T380A Intrauterine Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Estimate the time required to enroll 140 women into this study
Measured: 6 months
Secondary outcomes (2)
Expulsion rates
Estimate the expulsion rate of the CuT380A-IUCD
Measured: 6 months
Satisfaction
Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
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 ContraceptionStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Bryant, University of North Carolina, Chapel Hill
- Investigators
- Amy G Bryant, MD, Principal investigator, University of North Carolina, Chapel HillGretchen S Stuart, MD, MPHTM, Study director, University of Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175161
- Sponsor's protocol ID
- CID-0925
- Acronym
- PPIUD
- Status last verified
- Dec 2011
- First submitted
- 2 Aug 2010
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013 Jun;17(2):72-9.
PubMed 24069753
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT01175161
- Acronym / sponsor ID
- PPIUD / CID-0925
- Conditions
- Contraception, Intrauterine Devices, Pilot Study, Africa
- Keywords
- Postpartum Contraception, Intrauterine device, feasibility, IUD, Immediate postpartum IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Aug 2010 (estimated)
- 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 purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.
The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.
Detailed description
Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate postpartum IUD insertion | Experimental | Device: Copper T380A Intrauterine DeviceWomen assigned to have the IUD placed 10 minutes to 48 hours postpartum |
| 6 week postpartum IUD insertion | Experimental | Device: Copper T380A Intrauterine DeviceWomen who receive the IUD at the traditional time frame. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Primary Inclusion Criteria:
- Secondary Eligibility Criteria
- Vaginal delivery within the last 48 hours
- No postpartum hemorrhage documented by the delivering clinician
- Not known to have ruptured membranes for greater than 24 hours prior to delivery
Key exclusion criteria (6 listed)
- prior cesarean section
- fever during labor and delivery
- AIDS, not well on antiretroviral therapy
- genital tuberculosis
- known uterine abnormalities or genital tract cancer
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 |
|---|---|---|
| Copper T380A Intrauterine Devicethe Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum. | Device | 6 week postpartum IUD insertion, Immediate postpartum IUD insertion |
Primary outcome
Time
Time frame: 6 months
Estimate the time required to enroll 140 women into this study
2 secondary outcomes
Expulsion rates
Time frame: 6 months
Satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- Derived from this study: PubMed 24069753Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013 Jun;17(2):72-9.
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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.
Amy G Bryant, MD principal investigator
University of North Carolina, Chapel Hill
Gretchen S Stuart, MD, MPHTM study director
University of Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper T380A Intrauterine Device in people with Contraception and Intrauterine Devices, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 22 inclusion and 6 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: finished, as of the sponsor's last update on 7 Dec 2011. 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 Malawi. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time (time frame: 6 months). 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 NCT01175161, 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 7 Dec 2011.