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

This study has been completed.
Sponsor:
Collaborators:
Mulago Hospital, Uganda
Brigham and Women's Hospital
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT01293760
First received: February 10, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Contraception
Other: Immediate insertion
Other: 6 weeks interval insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • 6 month IUD usage rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • IUD Expulsion [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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

  • IUD Removal [ Time Frame: within six months ] [ Designated as safety issue: No ]
    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

  • IUD insertion [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    The proportion of participants receiving a Copper T 380A in each group

  • Pregnancy [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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

  • Infection [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study

  • Uterine Perforation [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 68
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
6 weeks interval insertion
IUD is inserted 6 weeks following c-section delivery of baby and placenta
Other: 6 weeks interval insertion
Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta
Experimental: Immediate insertion
IUD is inserted immediately following c-section delivery of baby and placenta
Other: Immediate insertion
Insertion of Copper T 380A immediately after c-section delivery of baby and placenta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnant at time of enrollment
  2. Scheduled to undergo non-emergent cesarean delivery
  3. Will have to wait at least 8 hours before their cesarean section
  4. Are not in active labor
  5. Desires to use the Copper T 380A for contraception
  6. Willing and able to sign an informed consent
  7. Willing to comply with the study protocol
  8. Age greater than or equal to 18 years
  9. English or Luganda speaking
  10. 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.

Exclusion Criteria:

  1. Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
  2. Positive N. gonorrheae or C. trachomatis testing
  3. Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
  4. Uterine anomaly which would not allow placement of the Copper T 380A
  5. Current cervical cancer or carcinoma in-situ
  6. Desire for repeat pregnancy in less than 12 months
  7. Evidence of intra-uterine infection (Chorioamnionitis)
  8. Pre-term birth prior to 34 weeks of gestation
  9. Diagnosis of AIDS (HIV is not an exclusion criteria)
  10. Fetal demise
  11. Antepartum hemorrhage
  12. Ruptured uterus
  13. Eclampsia
  14. Evidence of severe anemia

Post enrollment exclusion criteria

  1. Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
  2. 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
  3. Group 1: Prolonged rupture of membranes > 12 hours
  4. 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.
  5. Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
  6. Both Groups: Participant no longer desires a Copper T 380A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293760

Locations
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Mulago Hospital, Uganda
Brigham and Women's Hospital
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator Planned Parenthood League of Massachusetts
  More Information

No publications provided

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01293760     History of Changes
Other Study ID Numbers: 2010p001355
Study First Received: February 10, 2011
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board
Uganda: Institutional Review Board (Uganda National Council for Science and Technology)
Uganda: Institutional Review Board (Makerere University Research and Ethics Committee)

Keywords provided by Planned Parenthood League of Massachusetts:
intrauterine device
contraception

Additional relevant MeSH terms:
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014