- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293760
Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda
- Mulago Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 6 weeks interval insertion
IUD is inserted 6 weeks following c-section delivery of baby and placenta
|
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
|
Insertion of Copper T 380A immediately after c-section delivery of baby and placenta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 month IUD usage rates
Time Frame: 6 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IUD Expulsion
Time Frame: within 6 months
|
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
|
IUD Removal
Time Frame: within six months
|
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
|
IUD insertion
Time Frame: within 6 months
|
The proportion of participants receiving a Copper T 380A in each group
|
within 6 months
|
Pregnancy
Time Frame: within 6 months
|
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
|
Infection
Time Frame: within 6 months
|
The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study
|
within 6 months
|
Uterine Perforation
Time Frame: within 6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Principal Investigator, Planned Parenthood League of Massachusetts
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010p001355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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