PostpartumPPIUDNCT02706340
Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study
An observational study of Postpartum and Intrauterine Devices, Copper, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, Intrauterine Devices, Copper
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult pregnant women, at least 24 weeks' gestation, anticipating a delivery and desiring an immediate postplacental TCu380A IUD, and adult women who have had a delivery and received an immediate post placental TCu380A IUD.
Who may be able to join
- Adult woman age 18 years or more
- Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
- Anticipating a delivery at the Hospital of the University of Pennsylvania
- Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
- Able and willing to give consent in English
- Willing to follow up 6 months after delivery
Who cannot join
- Allergy or contraindication to TCu380A
- Known cervical cancer or carcinoma in situ
- History of undiagnosed abnormal vaginal bleeding prior to pregnancy
- Unwilling to follow up in the six months following delivery will be excluded
- Additional exclusion criteria apply after delivery:
- Preterm delivery (33 weeks 6 days gestation or less at birth)
Show all 10Show fewer
- Clinical diagnosis of chorioamnionitis or treatment for presumed chorioamnionitis
- No longer desiring immediate postplacental TCu380A placement
- Subjects aged less than 18 years
- Men are excluded by the nature of this women's health research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19143
About this study
Official title: Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study (PPIUD)
This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.
Read the detailed description
The purpose of the study is to measure the rate of expulsion of the copper intrauterine device (ParaGard®) when placed immediately after childbirth. Many women in the United States have unintended pregnancies. Long-acting reversible birth control methods, like the copper intrauterine device (IUD), help prevent unintended pregnancy. This is because, once in place, the copper IUD provides excellent pregnancy prevention, and women using it do not have to do anything extra to make sure it works (like taking a birth control pill every day, for example). The copper IUD is safe and well liked among women who use it. Around the world, women have been getting their IUD fitted right after childbirth for the past 20 years, and this practice has been shown to be safe. This service has been offered at HUP since early 2014. When the IUD is placed after birth, there is a chance that it could fall out, as the uterus shrinks back to its pre-pregnancy size. Women who get their IUD fitted right after childbirth will be observed, and describe the rate of IUD expulsion at 6 months postpartum. Factors associated with IUD expulsion will be noted. Adult pregnant women delivering at the Hospital of the University of Pennsylvania, desiring an immediate IUD, and willing to follow up 6 months after birth, will be eligible to participate.
- Conditions
- Postpartum, Intrauterine Devices, Copper
- Being tested
- No intervention - observational study only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational study onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery | Women who have had a copper IUD placed within 10 minutes of a vaginal delivery of at least 34 weeks 0 days gestation. Receives: Other: No intervention - observational study only | |
| Cesarean delivery | Women who have had a copper IUD placed within 10 minutes of a cesarean delivery of at least 34 weeks 0 days gestation. Receives: Other: No intervention - observational study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania.
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 posted11 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706340
- Sponsor's protocol ID
- 822078
- Acronym
- PPIUD
- Status last verified
- Nov 2018
- First submitted
- 26 Jan 2016
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study (PPIUD)
- ClinicalTrials.gov ID
- NCT02706340
- Acronym / sponsor ID
- PPIUD / 822078
- Conditions
- Postpartum, Intrauterine Devices, Copper
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Mar 2016 (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.
This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.
Detailed description
The purpose of the study is to measure the rate of expulsion of the copper intrauterine device (ParaGard®) when placed immediately after childbirth. Many women in the United States have unintended pregnancies. Long-acting reversible birth control methods, like the copper intrauterine device (IUD), help prevent unintended pregnancy. This is because, once in place, the copper IUD provides excellent pregnancy prevention, and women using it do not have to do anything extra to make sure it works (like taking a birth control pill every day, for example). The copper IUD is safe and well liked among women who use it. Around the world, women have been getting their IUD fitted right after childbirth for the past 20 years, and this practice has been shown to be safe. This service has been offered at HUP since early 2014. When the IUD is placed after birth, there is a chance that it could fall out, as the uterus shrinks back to its pre-pregnancy size. Women who get their IUD fitted right after childbirth will be observed, and describe the rate of IUD expulsion at 6 months postpartum. Factors associated with IUD expulsion will be noted. Adult pregnant women delivering at the Hospital of the University of Pennsylvania, desiring an immediate IUD, and willing to follow up 6 months after birth, will be eligible to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery | – | Other: No intervention - observational study onlyWomen who have had a copper IUD placed within 10 minutes of a vaginal delivery of at least 34 weeks 0 days gestation. |
| Cesarean delivery | – | Other: No intervention - observational study onlyWomen who have had a copper IUD placed within 10 minutes of a cesarean delivery of at least 34 weeks 0 days gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult pregnant women, at least 24 weeks' gestation, anticipating a delivery and desiring an immediate postplacental TCu380A IUD, and adult women who have had a delivery and received an immediate post placental TCu380A IUD.
Key inclusion criteria (6 listed)
- Adult woman age 18 years or more
- Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
- Anticipating a delivery at the Hospital of the University of Pennsylvania
- Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
- Able and willing to give consent in English
Key exclusion criteria (10 listed)
- Allergy or contraindication to TCu380A
- Known cervical cancer or carcinoma in situ
- History of undiagnosed abnormal vaginal bleeding prior to pregnancy
- Unwilling to follow up in the six months following delivery will be excluded
- Preterm delivery (33 weeks 6 days gestation or less at birth)
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 |
|---|---|---|
| No intervention - observational study only | Other | Cesarean delivery, Vaginal delivery |
Primary outcome
The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania.
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 15 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum and Intrauterine Devices, Copper, run by University of Pennsylvania at 1 site in United States.
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 6 inclusion and 10 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 15 Nov 2018. 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 United States. 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?
The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2018.