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ContraceptionNCT01293760

Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion

A study testing Immediate insertion and 6 weeks interval insertion in people with Contraception, run by Planned Parenthood League of Massachusetts at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Immediate insertion and 6 weeks interval insertion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUganda
Study dates
Feb 2011to Nov 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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant at time of enrollment
  • Scheduled to undergo non-emergent cesarean delivery
  • Will have to wait at least 8 hours before their cesarean section
  • Are not in active labor
  • Desires to use the Copper T 380A for contraception
  • Willing and able to sign an informed consent
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  • Willing to comply with the study protocol
  • Age greater than or equal to 18 years
  • English or Luganda speaking
  • Willing to be accompanied home upon discharge from the hospital and have their address recorded in order to be able to visit them at home at 6 months postpartum if they do not return for their 6 month follow-up visit.

Who cannot join

  • Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
  • Positive N. gonorrheae or C. trachomatis testing
  • Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
  • Uterine anomaly which would not allow placement of the Copper T 380A
  • Current cervical cancer or carcinoma in-situ
  • Desire for repeat pregnancy in less than 12 months
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  • Evidence of intra-uterine infection (Chorioamnionitis)
  • Pre-term birth prior to 34 weeks of gestation
  • Diagnosis of AIDS (HIV is not an exclusion criteria)
  • Fetal demise
  • Antepartum hemorrhage
  • Ruptured uterus
  • Eclampsia
  • Evidence of severe anemia
  • Post enrollment exclusion criteria
  • Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
  • Group 1: Post-partum hemorrhage with continued active bleeding that does not allow placement of the Copper T 380A within 10 minutes of the delivery of the placenta
  • Group 1: Prolonged rupture of membranes > 12 hours
  • Group 2: Diagnosis of active cervical infection within 3 months of planned insertion, or evidence of active pelvic or cervical infection, pus at the cervical os or any concern for upper genital tract infection, including fever (temperature ≥ 38° C) or uterine or adnexal tenderness. Diagnosis of new pregnancy.
  • Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
  • Both Groups: Participant no longer desires a Copper T 380A

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Mulago Hospital

    Kampala

Other trials in Uganda

About this study

Official title: Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial

The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up.

The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.

Conditions
Contraception
Being tested
Immediate insertion, 6 weeks interval insertion
Keywords
intrauterine device, contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate insertionOther

    Insertion of Copper T 380A immediately after c-section delivery of baby and placenta

  • 6 weeks interval insertionOther

    Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta

Study groups in NCT01293760
Study groupRoleWhat they receive
6 weeks interval insertionOtherIUD is inserted 6 weeks following c-section delivery of baby and placenta
Receives: Other: 6 weeks interval insertion
Immediate insertionExperimentalIUD is inserted immediately following c-section delivery of baby and placenta
Receives: Other: Immediate insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 month IUD usage rates

    The number of participants enrolled who are using the Copper T 380A at 6 months post-delivery. This will include participants who are excluded at time of delivery or interval insertion and participants who do not follow up for interval Copper T 380A insertion

    Measured: 6 months

Secondary outcomes (6)

  1. IUD Expulsion

    The time until expulsion of the Copper T 380A will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the Copper T 380A is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial

    Measured: within 6 months

  2. IUD Removal

    The proportion of participants who have the Copper T 380A inserted and who deliberately have it removed. We will also analyze the time to removal for these participants

    Measured: within six months

  3. IUD insertion

    The proportion of participants receiving a Copper T 380A in each group

    Measured: within 6 months

  4. Pregnancy

    Time to pregnancy will be calculated from the date of delivery until the estimated date of conception of a subsequent pregnancy, as based on sonographic dating. If sonographic dating is not available, the date of the last missed menses or three weeks before the first positive urine pregnancy test (if amenorrheic or oligomenorrheic) will be used

    Measured: within 6 months

  5. Infection

    The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study

    Measured: within 6 months

  6. Uterine Perforation

    The diagnosis of a perforation may be made by a transvaginal sonogram that shows no Copper T 380A within the uterus and an abdominal radiograph that shows a Copper T 380A within the abdominal cavity

    Measured: within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01293760
Sponsor's protocol ID
2010p001355
Status last verified
May 2012
First submitted
10 Feb 2011
Last updated
10 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

    PubMed 36302159

  • Lester F, Kakaire O, Byamugisha J, Averbach S, Fortin J, Maurer R, Goldberg A. Intracesarean insertion of the Copper T380A versus 6 weeks postcesarean: a randomized clinical trial. Contraception. 2015 Mar;91(3):198-203. doi: 10.1016/j.contraception.2014.12.002. Epub 2014 Dec 12.

    PubMed 25499587

Questions about this trial

What is this clinical trial studying?

A study testing Immediate insertion and 6 weeks interval insertion in people with Contraception, run by Planned Parenthood League of Massachusetts at 1 site in Uganda.

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 10 inclusion and 21 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 10 May 2012. 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 Uganda. 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?

6 month IUD usage rates (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 NCT01293760, which also lists 2 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 10 May 2012.

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