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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01293760
Other study ID # 2010p001355
Secondary ID
Status Completed
Phase N/A
First received February 10, 2011
Last updated May 8, 2012
Start date February 2011
Est. completion date November 2011

Study information

Verified date May 2012
Source Planned Parenthood League of Massachusetts
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUganda: Institutional Review Board (Uganda National Council for Science and Technology)Uganda: Institutional Review Board (Makerere University Research and Ethics Committee)
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Immediate insertion
Insertion of Copper T 380A immediately after c-section delivery of baby and placenta
6 weeks interval insertion
Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta

Locations

Country Name City State
Uganda Mulago Hospital Kampala

Sponsors (4)

Lead Sponsor Collaborator
Planned Parenthood League of Massachusetts Brigham and Women's Hospital, Mulago Hospital, Uganda, Society of Family Planning

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months No
Secondary 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 within 6 months No
Secondary 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 within six months No
Secondary IUD insertion The proportion of participants receiving a Copper T 380A in each group within 6 months No
Secondary 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 within 6 months No
Secondary Infection The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study within 6 months No
Secondary 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 within 6 months No
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