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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293760
• Other study ID #: 2010p001355
• 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

• Contraception

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